Trial Outcomes & Findings for Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers (NCT NCT05148962)
NCT ID: NCT05148962
Last Updated: 2024-12-11
Results Overview
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Within 8 Days After the Injection of Prime Dose on Day 1
Results posted on
2024-12-11
Participant Flow
The participants were enrolled at 3 sites in United Kingdom. A total of 61 participants were screened and 45 participants were enrolled in 6 cohorts (Cohorts 1 to 6).
Of 45 enrolled participants, 1 participant was enrolled in Cohort 5; however, the sponsor decided to terminate this participant prior to the study vaccination and close the recruitment of Cohort 5. As a result, Cohort 5 was removed from the GO-009 study. Therefore, the results include participants enrolled in Cohorts 1, 2, 3, 4, and 6.
Participant milestones
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
8
|
10
|
12
|
3
|
|
Overall Study
Vaccinated
|
10
|
7
|
10
|
10
|
3
|
|
Overall Study
COMPLETED
|
10
|
7
|
7
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
7
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Participant was early terminated per protocol
|
0
|
0
|
3
|
5
|
2
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of GRT-R910 COVID-19 Boost Vaccine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 6.61 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 5.06 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 3.95 • n=5 Participants
|
73.5 years
STANDARD_DEVIATION 5.40 • n=4 Participants
|
33.0 years
STANDARD_DEVIATION 11.36 • n=21 Participants
|
66.1 years
STANDARD_DEVIATION 11.46 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 8 Days After the Injection of Prime Dose on Day 1Population: SAF population
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Local Adverse Event (AE) Within 8 Days After the Injection of Prime Dose
|
8 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6)Population: Participants in the SAF population who received booster dose and submitted any data for the solicited AEs.
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited local AEs included injection site pain, injection site tenderness, injection site erythema, injection site edema/induration. Solicited AEs (reactogenicity) were collected using a memory aid.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Local AE Within 8 Days After the Injection of Booster Dose
|
6 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 8 Days After the Injection of Prime Dose on Day 1Population: SAF population
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Prime Dose
|
8 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 8 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6)Population: Participants in the SAF population who received booster dose and submitted any data for the solicited AEs.
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. Solicited systemic AEs included headache, fatigue, malaise, myalgia, arthralgia, nausea, fever, and chills. Solicited AEs (reactogenicity) were collected using a memory aid.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Solicited Systemic AE Within 8 Days After the Injection of Booster Dose
|
4 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days After the Injection of Prime Dose on Day 1Population: SAF population
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Unsolicited Treatment-emergent AEs (TEAEs) Within 28 Days After the Injection of Prime Dose
|
5 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 28 Days After the Injection of Booster Dose on Day 113 (Cohorts 1, 2); Within 8 Days After the Injection of Booster Dose on Day 29 (Cohorts 3, 4, 6)Population: Participants in the SAF population who received booster dose were analyzed.
An AE was defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related in a participant or clinical investigation participant who administered a pharmaceutical product regardless of its causal relationship to the study treatment. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Unsolicited TEAEs Within 28 Days After the Injection of Booster Dose
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Basophils : Baseline
|
0.033 10^9 cells per liter
Standard Deviation 0.0150
|
0.017 10^9 cells per liter
Standard Deviation 0.0153
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Basophils : Change at Day 8
|
-0.003 10^9 cells per liter
Standard Deviation 0.0126
|
-0.003 10^9 cells per liter
Standard Deviation 0.0115
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Eosinophils : Baseline
|
0.185 10^9 cells per liter
Standard Deviation 0.1420
|
0.137 10^9 cells per liter
Standard Deviation 0.0874
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Eosinophils : Change at Day 8
|
0.073 10^9 cells per liter
Standard Deviation 0.1333
|
-0.040 10^9 cells per liter
Standard Deviation 0.0794
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Lymphocytes : Baseline
|
1.338 10^9 cells per liter
Standard Deviation 0.7852
|
1.203 10^9 cells per liter
Standard Deviation 0.8739
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Lymphocytes : Change at Day 8
|
-0.053 10^9 cells per liter
Standard Deviation 0.2109
|
-0.187 10^9 cells per liter
Standard Deviation 0.5052
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Monocytes : Baseline
|
0.430 10^9 cells per liter
Standard Deviation 0.1722
|
0.570 10^9 cells per liter
Standard Deviation 0.1442
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Monocytes : Change at Day 8
|
-0.023 10^9 cells per liter
Standard Deviation 0.1195
|
0.010 10^9 cells per liter
Standard Deviation 0.0500
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Neutrophils : Baseline
|
3.170 10^9 cells per liter
Standard Deviation 1.1786
|
5.057 10^9 cells per liter
Standard Deviation 0.5036
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Neutrophils : Change at Day 8
|
-0.443 10^9 cells per liter
Standard Deviation 0.9483
|
-1.610 10^9 cells per liter
Standard Deviation 0.9681
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Platelets : Baseline
|
199.8 10^9 cells per liter
Standard Deviation 65.20
|
276.0 10^9 cells per liter
Standard Deviation 53.86
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Platelets : Change at Day 8
|
-5.5 10^9 cells per liter
Standard Deviation 19.49
|
-39.0 10^9 cells per liter
Standard Deviation 29.87
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Leukocytes : Baseline
|
5.15 10^9 cells per liter
Standard Deviation 1.808
|
7.00 10^9 cells per liter
Standard Deviation 0.794
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Leukocytes : Change at Day 8
|
-0.43 10^9 cells per liter
Standard Deviation 1.348
|
-1.83 10^9 cells per liter
Standard Deviation 1.266
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Basophils : Baseline
|
0.040 10^9 cells per liter
Standard Deviation 0.0126
|
0.063 10^9 cells per liter
Standard Deviation 0.0359
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Basophils : Change at Day 8
|
-0.020 10^9 cells per liter
Standard Deviation 0.0110
|
-0.030 10^9 cells per liter
Standard Deviation 0.0216
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Eosinophils : Baseline
|
0.128 10^9 cells per liter
Standard Deviation 0.1783
|
0.143 10^9 cells per liter
Standard Deviation 0.0846
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Eosinophils : Change at Day 8
|
0.037 10^9 cells per liter
Standard Deviation 0.0866
|
-0.043 10^9 cells per liter
Standard Deviation 0.0150
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Lymphocytes : Baseline
|
1.510 10^9 cells per liter
Standard Deviation 0.3653
|
1.610 10^9 cells per liter
Standard Deviation 0.3350
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Lymphocytes : Change at Day 8
|
0.088 10^9 cells per liter
Standard Deviation 0.1731
|
-0.223 10^9 cells per liter
Standard Deviation 0.1209
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Monocytes : Baseline
|
0.490 10^9 cells per liter
Standard Deviation 0.1456
|
0.558 10^9 cells per liter
Standard Deviation 0.2152
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Monocytes : Change at Day 8
|
-0.028 10^9 cells per liter
Standard Deviation 0.0708
|
-0.053 10^9 cells per liter
Standard Deviation 0.0789
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Neutrophils : Baseline
|
5.205 10^9 cells per liter
Standard Deviation 1.3505
|
4.003 10^9 cells per liter
Standard Deviation 1.3023
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Neutrophils : Change at Day 8
|
-1.165 10^9 cells per liter
Standard Deviation 0.8976
|
-0.970 10^9 cells per liter
Standard Deviation 1.0519
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Platelets : Baseline
|
269.0 10^9 cells per liter
Standard Deviation 95.68
|
271.8 10^9 cells per liter
Standard Deviation 21.36
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Platelets : Change at Day 8
|
-43.5 10^9 cells per liter
Standard Deviation 54.70
|
-26.5 10^9 cells per liter
Standard Deviation 42.07
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Leukocytes : Baseline
|
7.37 10^9 cells per liter
Standard Deviation 1.325
|
6.40 10^9 cells per liter
Standard Deviation 1.679
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Leukocytes : Change at Day 8
|
-1.07 10^9 cells per liter
Standard Deviation 0.954
|
-1.35 10^9 cells per liter
Standard Deviation 0.929
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 120Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Basophils : Baseline
|
0.040 10^9 cells per liter
Standard Deviation 0.0126
|
0.063 10^9 cells per liter
Standard Deviation 0.0359
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Basophils : Change at Day 120
|
-0.013 10^9 cells per liter
Standard Deviation 0.0103
|
-0.030 10^9 cells per liter
Standard Deviation 0.0163
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Eosinophils : Change at Day 120
|
0.032 10^9 cells per liter
Standard Deviation 0.0581
|
-0.013 10^9 cells per liter
Standard Deviation 0.0263
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Lymphocytes : Baseline
|
1.510 10^9 cells per liter
Standard Deviation 0.3653
|
1.610 10^9 cells per liter
Standard Deviation 0.3350
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Lymphocytes : Change at Day 120
|
0.192 10^9 cells per liter
Standard Deviation 0.1873
|
-0.143 10^9 cells per liter
Standard Deviation 0.1477
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Monocytes : Baseline
|
0.490 10^9 cells per liter
Standard Deviation 0.1456
|
0.558 10^9 cells per liter
Standard Deviation 0.2152
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Monocytes : Change at Day 120
|
-0.040 10^9 cells per liter
Standard Deviation 0.0363
|
-0.108 10^9 cells per liter
Standard Deviation 0.1646
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Neutrophils : Baseline
|
5.205 10^9 cells per liter
Standard Deviation 1.3505
|
4.003 10^9 cells per liter
Standard Deviation 1.3023
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Neutrophils : Change at Day 120
|
-2.040 10^9 cells per liter
Standard Deviation 0.8313
|
-1.170 10^9 cells per liter
Standard Deviation 0.3218
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Platelets : Baseline
|
269.0 10^9 cells per liter
Standard Deviation 95.68
|
271.8 10^9 cells per liter
Standard Deviation 21.36
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Platelets : Change at Day 120
|
-21.3 10^9 cells per liter
Standard Deviation 36.79
|
-31.5 10^9 cells per liter
Standard Deviation 54.86
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Leukocytes : Baseline
|
7.37 10^9 cells per liter
Standard Deviation 1.325
|
6.40 10^9 cells per liter
Standard Deviation 1.679
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Leukocytes : Change at Day 120
|
-1.87 10^9 cells per liter
Standard Deviation 0.898
|
-1.50 10^9 cells per liter
Standard Deviation 0.392
|
—
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Eosinophils : Baseline
|
0.128 10^9 cells per liter
Standard Deviation 0.1783
|
0.143 10^9 cells per liter
Standard Deviation 0.0846
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Basophils : Baseline
|
0.047 10^9 cells per liter
Standard Deviation 0.0250
|
0.047 10^9 cells per liter
Standard Deviation 0.0125
|
0.043 10^9 cells per liter
Standard Deviation 0.0115
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Basophils : Change at Day 8
|
-0.020 10^9 cells per liter
Standard Deviation 0.0176
|
-0.022 10^9 cells per liter
Standard Deviation 0.0132
|
-0.023 10^9 cells per liter
Standard Deviation 0.0058
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Eosinophils : Baseline
|
0.123 10^9 cells per liter
Standard Deviation 0.1311
|
0.126 10^9 cells per liter
Standard Deviation 0.0875
|
0.107 10^9 cells per liter
Standard Deviation 0.0569
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Eosinophils : Change at Day 8
|
0.022 10^9 cells per liter
Standard Deviation 0.0721
|
0.009 10^9 cells per liter
Standard Deviation 0.0493
|
-0.047 10^9 cells per liter
Standard Deviation 0.0289
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Lymphocytes : Baseline
|
1.574 10^9 cells per liter
Standard Deviation 0.4610
|
1.639 10^9 cells per liter
Standard Deviation 0.9816
|
1.507 10^9 cells per liter
Standard Deviation 0.1793
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Lymphocytes : Change at Day 8
|
-0.006 10^9 cells per liter
Standard Deviation 0.2913
|
-0.170 10^9 cells per liter
Standard Deviation 0.2732
|
-0.293 10^9 cells per liter
Standard Deviation 0.0306
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Monocytes : Baseline
|
0.481 10^9 cells per liter
Standard Deviation 0.1194
|
0.508 10^9 cells per liter
Standard Deviation 0.1160
|
0.373 10^9 cells per liter
Standard Deviation 0.1464
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Monocytes : Change at Day 8
|
-0.066 10^9 cells per liter
Standard Deviation 0.0929
|
-0.131 10^9 cells per liter
Standard Deviation 0.1058
|
-0.120 10^9 cells per liter
Standard Deviation 0.1323
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Platelets : Baseline
|
230.2 10^9 cells per liter
Standard Deviation 30.53
|
249.4 10^9 cells per liter
Standard Deviation 59.23
|
267.0 10^9 cells per liter
Standard Deviation 23.58
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Platelets : Change at Day 8
|
12.5 10^9 cells per liter
Standard Deviation 41.25
|
-20.3 10^9 cells per liter
Standard Deviation 25.58
|
-19.7 10^9 cells per liter
Standard Deviation 70.32
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Leukocytes : Change at Day 8
|
-0.650 10^9 cells per liter
Standard Deviation 0.9058
|
-1.350 10^9 cells per liter
Standard Deviation 0.6042
|
-1.367 10^9 cells per liter
Standard Deviation 0.8963
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Neutrophils : Baseline
|
3.701 10^9 cells per liter
Standard Deviation 1.4781
|
3.921 10^9 cells per liter
Standard Deviation 0.7834
|
2.643 10^9 cells per liter
Standard Deviation 0.6831
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Neutrophils : Change at Day 8
|
-0.645 10^9 cells per liter
Standard Deviation 0.7103
|
-1.041 10^9 cells per liter
Standard Deviation 0.6897
|
-0.920 10^9 cells per liter
Standard Deviation 0.9885
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 8 in Cohorts 3, 4, and 6
Leukocytes : Baseline
|
5.920 10^9 cells per liter
Standard Deviation 1.7261
|
6.240 10^9 cells per liter
Standard Deviation 1.2834
|
4.633 10^9 cells per liter
Standard Deviation 0.7506
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 37Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Basophils : Baseline
|
0.047 10^9 cells per liter
Standard Deviation 0.0250
|
0.047 10^9 cells per liter
Standard Deviation 0.0125
|
0.043 10^9 cells per liter
Standard Deviation 0.0115
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Basophils : Change at Day 37
|
-0.013 10^9 cells per liter
Standard Deviation 0.0116
|
-0.014 10^9 cells per liter
Standard Deviation 0.0117
|
-0.017 10^9 cells per liter
Standard Deviation 0.0115
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Eosinophils : Baseline
|
0.123 10^9 cells per liter
Standard Deviation 0.1311
|
0.126 10^9 cells per liter
Standard Deviation 0.0875
|
0.107 10^9 cells per liter
Standard Deviation 0.0569
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Lymphocytes : Change at Day 37
|
0.021 10^9 cells per liter
Standard Deviation 0.3380
|
-0.140 10^9 cells per liter
Standard Deviation 0.3636
|
-0.253 10^9 cells per liter
Standard Deviation 0.1343
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Monocytes : Baseline
|
0.481 10^9 cells per liter
Standard Deviation 0.1194
|
0.508 10^9 cells per liter
Standard Deviation 0.1160
|
0.373 10^9 cells per liter
Standard Deviation 0.1464
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Platelets : Baseline
|
230.2 10^9 cells per liter
Standard Deviation 30.53
|
249.4 10^9 cells per liter
Standard Deviation 59.23
|
267.0 10^9 cells per liter
Standard Deviation 23.58
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Platelets : Change at Day 37
|
37.4 10^9 cells per liter
Standard Deviation 65.25
|
-4.5 10^9 cells per liter
Standard Deviation 21.18
|
13.3 10^9 cells per liter
Standard Deviation 60.68
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Eosinophils : Change at Day 37
|
0.013 10^9 cells per liter
Standard Deviation 0.0523
|
0.001 10^9 cells per liter
Standard Deviation 0.0669
|
-0.033 10^9 cells per liter
Standard Deviation 0.0153
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Lymphocytes : Baseline
|
1.574 10^9 cells per liter
Standard Deviation 0.4610
|
1.639 10^9 cells per liter
Standard Deviation 0.9816
|
1.507 10^9 cells per liter
Standard Deviation 0.1793
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Monocytes : Change at Day 37
|
0.033 10^9 cells per liter
Standard Deviation 0.1585
|
-0.107 10^9 cells per liter
Standard Deviation 0.1846
|
-0.030 10^9 cells per liter
Standard Deviation 0.1044
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Neutrophils : Baseline
|
3.701 10^9 cells per liter
Standard Deviation 1.4781
|
3.921 10^9 cells per liter
Standard Deviation 0.7834
|
2.643 10^9 cells per liter
Standard Deviation 0.6831
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Neutrophils : Change at Day 37
|
-0.136 10^9 cells per liter
Standard Deviation 0.8558
|
-0.125 10^9 cells per liter
Standard Deviation 0.7983
|
0.000 10^9 cells per liter
Standard Deviation 1.4504
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Leukocytes : Baseline
|
5.920 10^9 cells per liter
Standard Deviation 1.7261
|
6.240 10^9 cells per liter
Standard Deviation 1.2834
|
4.633 10^9 cells per liter
Standard Deviation 0.7506
|
—
|
—
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes at Day 37 in Cohorts 3, 4, and 6
Leukocytes : Change at Day 37
|
-0.070 10^9 cells per liter
Standard Deviation 0.9900
|
-0.390 10^9 cells per liter
Standard Deviation 0.8556
|
-0.280 10^9 cells per liter
Standard Deviation 1.4153
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Hemoglobin : Baseline
|
131.5 g/L
Standard Deviation 12.58
|
136.7 g/L
Standard Deviation 11.85
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Hemoglobin : Change at Day 8
|
-3.8 g/L
Standard Deviation 3.50
|
-4.0 g/L
Standard Deviation 1.73
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Hemoglobin : Baseline
|
137.8 g/L
Standard Deviation 13.01
|
144.8 g/L
Standard Deviation 7.97
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Hemoglobin : Change at Day 8
|
-5.5 g/L
Standard Deviation 5.24
|
-7.0 g/L
Standard Deviation 10.10
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 120Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Hemoglobin : Baseline
|
137.8 g/L
Standard Deviation 13.01
|
144.8 g/L
Standard Deviation 7.97
|
—
|
—
|
—
|
|
Change From Baseline in Hemoglobin at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Hemoglobin : Change at Day 120
|
-4.8 g/L
Standard Deviation 4.54
|
-5.3 g/L
Standard Deviation 2.75
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6
Hemoglobin : Baseline
|
136.3 g/L
Standard Deviation 9.25
|
139.0 g/L
Standard Deviation 8.69
|
130.3 g/L
Standard Deviation 6.03
|
—
|
—
|
|
Change From Baseline in Hemoglobin at Day 8 in Cohorts 3, 4, and 6
Hemoglobin : Change at Day 8
|
-5.9 g/L
Standard Deviation 3.25
|
-4.8 g/L
Standard Deviation 5.45
|
-5.7 g/L
Standard Deviation 6.35
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 37Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6
Hemoglobin : Change at Day 37
|
-8.0 g/L
Standard Deviation 4.62
|
-6.6 g/L
Standard Deviation 4.53
|
-11.0 g/L
Standard Deviation 6.08
|
—
|
—
|
|
Change From Baseline in Hemoglobin at Day 37 in Cohorts 3, 4, and 6
Hemoglobin : Baseline
|
136.3 g/L
Standard Deviation 9.25
|
139.0 g/L
Standard Deviation 8.69
|
130.3 g/L
Standard Deviation 6.03
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Baseline
|
75.0 International Units Per Liter (IU/L)
Standard Deviation 14.63
|
81.3 International Units Per Liter (IU/L)
Standard Deviation 24.01
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Change at Day 8
|
4.8 International Units Per Liter (IU/L)
Standard Deviation 13.35
|
1.7 International Units Per Liter (IU/L)
Standard Deviation 8.33
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Baseline
|
22.3 International Units Per Liter (IU/L)
Standard Deviation 7.63
|
17.3 International Units Per Liter (IU/L)
Standard Deviation 3.51
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Change at Day 8
|
11.8 International Units Per Liter (IU/L)
Standard Deviation 29.93
|
38.7 International Units Per Liter (IU/L)
Standard Deviation 39.32
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Baseline
|
24.5 International Units Per Liter (IU/L)
Standard Deviation 5.20
|
18.7 International Units Per Liter (IU/L)
Standard Deviation 2.89
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Change at Day 8
|
5.3 International Units Per Liter (IU/L)
Standard Deviation 11.35
|
14.7 International Units Per Liter (IU/L)
Standard Deviation 10.97
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Baseline
|
82.5 IU/L
Standard Deviation 20.50
|
67.5 IU/L
Standard Deviation 35.75
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Change at Day 8
|
4.8 IU/L
Standard Deviation 22.97
|
-12.5 IU/L
Standard Deviation 8.96
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Baseline
|
25.5 IU/L
Standard Deviation 13.34
|
18.3 IU/L
Standard Deviation 9.39
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Change at Day 8
|
2.5 IU/L
Standard Deviation 14.54
|
3.5 IU/L
Standard Deviation 8.66
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Baseline
|
23.5 IU/L
Standard Deviation 8.38
|
18.8 IU/L
Standard Deviation 1.50
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Change at Day 8
|
0.6 IU/L
Standard Deviation 6.66
|
3.0 IU/L
Standard Deviation 4.08
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 120Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose and who had available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Change at Day 120
|
-4.0 IU/L
Standard Deviation 11.03
|
4.3 IU/L
Standard Deviation 5.68
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Baseline
|
23.5 IU/L
Standard Deviation 8.38
|
18.8 IU/L
Standard Deviation 1.50
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Baseline
|
82.5 IU/L
Standard Deviation 20.50
|
67.5 IU/L
Standard Deviation 35.75
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Alkaline Phosphatase : Change at Day 120
|
-2.8 IU/L
Standard Deviation 18.65
|
-13.5 IU/L
Standard Deviation 10.41
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Alanine Aminotransferase : Baseline
|
25.5 IU/L
Standard Deviation 13.34
|
18.3 IU/L
Standard Deviation 9.39
|
—
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Aspartate Aminotransferase : Change at Day 120
|
-0.8 IU/L
Standard Deviation 4.50
|
1.0 IU/L
Standard Deviation 3.46
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Aspartate Aminotransferase : Change at Day 8
|
-0.1 IU/L
Standard Deviation 4.51
|
1.9 IU/L
Standard Deviation 8.55
|
1.5 IU/L
Standard Deviation 9.19
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Alkaline Phosphatase : Baseline
|
75.0 IU/L
Standard Deviation 19.96
|
83.9 IU/L
Standard Deviation 20.56
|
58.7 IU/L
Standard Deviation 6.81
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Alkaline Phosphatase : Change at Day 8
|
7.7 IU/L
Standard Deviation 10.67
|
-6.8 IU/L
Standard Deviation 13.10
|
-4.7 IU/L
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Alanine Aminotransferase : Baseline
|
25.6 IU/L
Standard Deviation 8.62
|
25.1 IU/L
Standard Deviation 9.42
|
14.3 IU/L
Standard Deviation 5.51
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Alanine Aminotransferase : Change at Day 8
|
-0.4 IU/L
Standard Deviation 5.17
|
7.2 IU/L
Standard Deviation 15.10
|
10.0 IU/L
Standard Deviation 14.73
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 8 in Cohorts 3, 4, and 6
Aspartate Aminotransferase : Baseline
|
25.2 IU/L
Standard Deviation 6.27
|
26.1 IU/L
Standard Deviation 5.71
|
21.5 IU/L
Standard Deviation 2.12
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 37Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Alkaline Phosphatase : Change at Day 37
|
-7.9 IU/L
Standard Deviation 8.13
|
0.2 IU/L
Standard Deviation 11.44
|
-1.7 IU/L
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Alanine Aminotransferase : Baseline
|
25.6 IU/L
Standard Deviation 8.62
|
25.1 IU/L
Standard Deviation 9.42
|
14.3 IU/L
Standard Deviation 5.51
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Alanine Aminotransferase : Change at Day 37
|
0.7 IU/L
Standard Deviation 7.83
|
3.2 IU/L
Standard Deviation 6.92
|
2.7 IU/L
Standard Deviation 0.58
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Aspartate Aminotransferase : Baseline
|
25.2 IU/L
Standard Deviation 6.27
|
26.1 IU/L
Standard Deviation 5.71
|
21.5 IU/L
Standard Deviation 2.12
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Aspartate Aminotransferase : Change at Day 37
|
1.9 IU/L
Standard Deviation 7.04
|
3.1 IU/L
Standard Deviation 8.61
|
-1.0 IU/L
|
—
|
—
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase at Day 37 in Cohorts 3, 4, and 6
Alkaline Phosphatase : Baseline
|
75.0 IU/L
Standard Deviation 19.96
|
83.9 IU/L
Standard Deviation 20.56
|
58.7 IU/L
Standard Deviation 6.81
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Bilirubin : Baseline
|
8.3 micromole per liter (µmol/L)
Standard Deviation 4.43
|
7.7 micromole per liter (µmol/L)
Standard Deviation 4.73
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Bilirubin : Change at Day 8
|
2.3 micromole per liter (µmol/L)
Standard Deviation 1.71
|
-0.3 micromole per liter (µmol/L)
Standard Deviation 2.52
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Creatinine : Baseline
|
79.0 micromole per liter (µmol/L)
Standard Deviation 15.87
|
66.3 micromole per liter (µmol/L)
Standard Deviation 14.36
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Creatinine : Change at Day 8
|
4.5 micromole per liter (µmol/L)
Standard Deviation 7.72
|
-3.7 micromole per liter (µmol/L)
Standard Deviation 3.79
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Bilirubin : Baseline
|
7.0 µmol/L
Standard Deviation 2.68
|
9.0 µmol/L
Standard Deviation 3.56
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Bilirubin : Change at Day 8
|
0.3 µmol/L
Standard Deviation 1.75
|
1.5 µmol/L
Standard Deviation 2.08
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Creatinine : Baseline
|
66.8 µmol/L
Standard Deviation 13.41
|
69.3 µmol/L
Standard Deviation 23.41
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Creatinine : Change at Day 8
|
3.5 µmol/L
Standard Deviation 2.26
|
-3.3 µmol/L
Standard Deviation 6.65
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 120Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Bilirubin : Baseline
|
7.0 µmol/L
Standard Deviation 2.68
|
9.0 µmol/L
Standard Deviation 3.56
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Bilirubin : Change at Day 120
|
0.2 µmol/L
Standard Deviation 2.56
|
-1.0 µmol/L
Standard Deviation 3.46
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Creatinine : Baseline
|
66.8 µmol/L
Standard Deviation 13.41
|
69.3 µmol/L
Standard Deviation 23.41
|
—
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Creatinine : Change at Day 120
|
2.7 µmol/L
Standard Deviation 8.87
|
-3.8 µmol/L
Standard Deviation 8.66
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6
Bilirubin : Baseline
|
8.2 µmol/L
Standard Deviation 3.16
|
7.6 µmol/L
Standard Deviation 3.06
|
19.3 µmol/L
Standard Deviation 14.74
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6
Bilirubin : Change at Day 8
|
-0.8 µmol/L
Standard Deviation 2.57
|
0.3 µmol/L
Standard Deviation 1.64
|
-8.0 µmol/L
Standard Deviation 9.85
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6
Creatinine : Baseline
|
66.6 µmol/L
Standard Deviation 16.15
|
63.7 µmol/L
Standard Deviation 14.94
|
61.3 µmol/L
Standard Deviation 5.86
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 8 in Cohorts 3, 4, and 6
Creatinine : Change at Day 8
|
3.7 µmol/L
Standard Deviation 4.42
|
0.8 µmol/L
Standard Deviation 2.95
|
-2.0 µmol/L
Standard Deviation 4.00
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 37Population: Participants in SAF population from Cohorts 3, 4, and 6 with available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6
Bilirubin : Baseline
|
8.2 µmol/L
Standard Deviation 3.16
|
7.6 µmol/L
Standard Deviation 3.06
|
19.3 µmol/L
Standard Deviation 14.74
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6
Bilirubin : Change at Day 37
|
-1.2 µmol/L
Standard Deviation 2.30
|
-0.4 µmol/L
Standard Deviation 2.07
|
-4.0 µmol/L
Standard Deviation 0.00
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6
Creatinine : Baseline
|
66.6 µmol/L
Standard Deviation 16.15
|
63.7 µmol/L
Standard Deviation 14.94
|
61.3 µmol/L
Standard Deviation 5.86
|
—
|
—
|
|
Change From Baseline in Bilirubin and Creatinine at Day 37 in Cohorts 3, 4, and 6
Creatinine : Change at Day 37
|
5.2 µmol/L
Standard Deviation 6.53
|
-1.2 µmol/L
Standard Deviation 4.39
|
1.7 µmol/L
Standard Deviation 5.51
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who did not receive the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Baseline
|
1.3083 microkatal per liter (μkat/L)
Standard Deviation 0.3869
|
1.1056 microkatal per liter (μkat/L)
Standard Deviation 0.5453
|
—
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Day 8 in Participants Without Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Change at Day 8
|
-0.2083 microkatal per liter (μkat/L)
Standard Deviation 0.1680
|
-0.3556 microkatal per liter (μkat/L)
Standard Deviation 0.3417
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Baseline
|
1.2917 μkat/L
Standard Deviation 0.5212
|
1.4708 μkat/L
Standard Deviation 0.6065
|
—
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Day 8 in Participants With Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Change at Day 8
|
-0.1417 μkat/L
Standard Deviation 0.2736
|
-0.2458 μkat/L
Standard Deviation 0.2002
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 120Population: Participants in the SAF population from Cohorts 1 and 2 who received the booster dose were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=4 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Baseline
|
1.2917 μkat/L
Standard Deviation 0.5212
|
1.4708 μkat/L
Standard Deviation 0.6065
|
—
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Day 120 in Participants With Booster Dose (Cohorts 1 and 2)
Creatine Kinase : Change at Day 120
|
0.0750 μkat/L
Standard Deviation 0.5691
|
-0.5625 μkat/L
Standard Deviation 0.2640
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: Participants in the SAF population from Cohorts 3, 4 and 6 were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6
Creatine Kinase : Baseline
|
2.2217 μkat/L
Standard Deviation 1.0841
|
1.9067 μkat/L
Standard Deviation 0.7348
|
1.8056 μkat/L
Standard Deviation 0.7473
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Day 8 in Cohorts 3, 4, and 6
Creatine Kinase : Change at Day 8
|
-0.4833 μkat/L
Standard Deviation 0.5619
|
-0.1217 μkat/L
Standard Deviation 0.4350
|
-0.4444 μkat/L
Standard Deviation 0.4703
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 37Population: Participants in the SAF population from Cohorts 3, 4 and 6 with available data were analyzed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6
Creatine Kinase : Change at Day 37
|
-0.4217 μkat/L
Standard Deviation 0.6258
|
-0.3583 μkat/L
Standard Deviation 0.4508
|
-0.4417 μkat/L
Standard Deviation 0.1532
|
—
|
—
|
|
Change From Baseline in Creatine Kinase at Day 37 in Cohorts 3, 4, and 6
Creatine Kinase : Baseline
|
2.2217 μkat/L
Standard Deviation 1.0841
|
1.9067 μkat/L
Standard Deviation 0.7348
|
1.8056 μkat/L
Standard Deviation 0.7473
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 Up to 16 monthsPopulation: SAF population
An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the vaccine. A TEAE was defined as any event not observed before the first vaccination or any event observed before the first vaccination that worsens in intensity or frequency after exposure. A treatment-emergent SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. Adverse events of special interest were serologically or virologically confirmed SARS-CoV-2 infection or severe COVID-19, NOCMCs, MAAE (hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel for any reason), and PIMMCs.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
SAEs
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
All AESIs
|
9 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
MAAEs
|
6 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
Severe COVID-19
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
PIMMCs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
NOCMCs
|
5 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Serious AEs (SAEs), AE of Special Interest (AESIs) Including Potentially Immune-mediated Medical Conditions (PIMMCs), Medically Attended AEs (MAAEs), and New Onset Chronic Medical Conditions (NOCMCs)
Serologically or Virologically Confirmed Relevant to COVID-19
|
7 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209, 293, 365, 394, 478Population: Immunogenicity analysis population included participants who received assigned dose(s) at baseline and had at least one available assessment at post-baseline. Participants with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
Sera were analyzed for Spike (WT variant)-specific IgG levels pre and post administration of GRT-R910 via enzyme-linked immunosorbent assay (ELISA) and reported as ELISA laboratory units (ELU)/mL (amount of antibodies in the sample according to the unit assigned by the standard).
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Baseline
|
1472.7 ELU/mL
Standard Deviation 2054.30
|
927.4 ELU/mL
Standard Deviation 1432.97
|
8154.3 ELU/mL
Standard Deviation 10615.60
|
16841.9 ELU/mL
Standard Deviation 25813.96
|
14127.5 ELU/mL
Standard Deviation 12307.51
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 15
|
—
|
—
|
127.6 ELU/mL
Standard Deviation 187.31
|
2172.0 ELU/mL
Standard Deviation 5047.29
|
-1710.6 ELU/mL
Standard Deviation 4374.86
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 29
|
11895.9 ELU/mL
Standard Deviation 13649.88
|
18911.4 ELU/mL
Standard Deviation 33885.50
|
12487.0 ELU/mL
Standard Deviation 32915.21
|
6894.5 ELU/mL
Standard Deviation 10642.03
|
-811.4 ELU/mL
Standard Deviation 4591.85
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 86
|
—
|
—
|
19988.1 ELU/mL
Standard Deviation 29698.91
|
19290.2 ELU/mL
Standard Deviation 29851.34
|
3598.0 ELU/mL
Standard Deviation 4584.89
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 113
|
5338.6 ELU/mL
Standard Deviation 2788.22
|
4429.0 ELU/mL
Standard Deviation 4194.22
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 142
|
9912.1 ELU/mL
Standard Deviation 3698.76
|
4325.1 ELU/mL
Standard Deviation 998.99
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 180
|
5617.7 ELU/mL
Standard Deviation 3997.75
|
43597.9 ELU/mL
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 209
|
—
|
—
|
19612.2 ELU/mL
Standard Deviation 25727.45
|
13302.7 ELU/mL
Standard Deviation 35861.57
|
669.2 ELU/mL
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 293
|
8168.6 ELU/mL
Standard Deviation 1102.84
|
1550.2 ELU/mL
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 365
|
6717.5 ELU/mL
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 394
|
—
|
—
|
29156.7 ELU/mL
Standard Deviation 34271.63
|
19892.7 ELU/mL
Standard Deviation 29538.44
|
-2550.5 ELU/mL
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 478
|
6280.8 ELU/mL
|
1787.8 ELU/mL
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 57
|
13611.5 ELU/mL
Standard Deviation 15451.74
|
18389.1 ELU/mL
Standard Deviation 32185.66
|
—
|
—
|
—
|
|
Change From Baseline in Immunoglobulin (Ig)G Level (Spike Wild Type [WT] Variant)
Change at Day 58
|
—
|
—
|
26631.5 ELU/mL
Standard Deviation 40900.86
|
20522.6 ELU/mL
Standard Deviation 23369.31
|
2764.7 ELU/mL
Standard Deviation 4119.63
|
SECONDARY outcome
Timeframe: For WT: Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394, 478; For Alpha, Beta, Delta, Gamma:Baseline, Days 15, 29, 57, 58, 86, 113, 142, 180, 209 293, 365, 394Population: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
Neutralizing antibody titers against live virus were assessed via microneutralization assay. Neutralizing antibody levels were measured for the following variants: WT, Alpha, Beta, Delta, Gamma.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 57
|
1791.3 titers
Standard Deviation 1761.22
|
11060.3 titers
Standard Deviation 25154.49
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 58
|
—
|
—
|
10524.0 titers
Standard Deviation 15090.23
|
1534.0 titers
Standard Deviation 1431.72
|
962.7 titers
Standard Deviation 829.00
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Baseline
|
389.3 titers
Standard Deviation 648.63
|
364.1 titers
Standard Deviation 531.95
|
1598.8 titers
Standard Deviation 1614.15
|
1770.6 titers
Standard Deviation 2197.25
|
2876.3 titers
Standard Deviation 2313.05
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 15
|
—
|
—
|
-181.5 titers
Standard Deviation 150.61
|
1291.3 titers
Standard Deviation 943.07
|
886.0 titers
Standard Deviation 751.13
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 113
|
1877.0 titers
Standard Deviation 1083.54
|
1273.0 titers
Standard Deviation 998.27
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 142
|
3933.0 titers
Standard Deviation 2349.21
|
1479.0 titers
Standard Deviation 804.08
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 180
|
2722.7 titers
Standard Deviation 2504.27
|
11020.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 209
|
—
|
—
|
1896.3 titers
Standard Deviation 1539.0
|
4046.8 titers
Standard Deviation 4136.43
|
3767.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 293
|
2527.3 titers
Standard Deviation 1758.06
|
412.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 365
|
469.0 titers
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 394
|
—
|
—
|
5771.5 titers
Standard Deviation 6639.03
|
6617.8 titers
Standard Deviation 8217.53
|
9904.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Baseline
|
212.2 titers
Standard Deviation 321.43
|
145.8 titers
Standard Deviation 199.14
|
472.5 titers
Standard Deviation 318.83
|
2888.6 titers
Standard Deviation 3326.23
|
2131.3 titers
Standard Deviation 1220.58
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 15
|
—
|
—
|
151.0 titers
Standard Deviation 4.24
|
-473.3 titers
Standard Deviation 2492.24
|
462.3 titers
Standard Deviation 670.00
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 29
|
2015.5 titers
Standard Deviation 1970.93
|
5750.8 titers
Standard Deviation 11303.79
|
5824.3 titers
Standard Deviation 10927.20
|
508.2 titers
Standard Deviation 2193.32
|
492.7 titers
Standard Deviation 169.21
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 86
|
—
|
—
|
12548.7 titers
Standard Deviation 16593.11
|
2793.7 titers
Standard Deviation 1513.65
|
6464.3 titers
Standard Deviation 6400.08
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 113
|
742.0 titers
Standard Deviation 435.92
|
690.7 titers
Standard Deviation 501.34
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 142
|
1222.0 titers
Standard Deviation 341.83
|
647.0 titers
Standard Deviation 381.84
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Baseline
|
46.8 titers
Standard Deviation 24.53
|
54.8 titers
Standard Deviation 58.38
|
3049.0 titers
Standard Deviation 5611.44
|
728.2 titers
Standard Deviation 714.93
|
692.7 titers
Standard Deviation 333.52
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 15
|
—
|
—
|
241.0 titers
Standard Deviation 101.82
|
1325.3 titers
Standard Deviation 1151.95
|
670.0 titers
Standard Deviation 323.30
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 58
|
—
|
—
|
491.0 titers
Standard Deviation 480.77
|
908.7 titers
Standard Deviation 725.16
|
355.0 titers
Standard Deviation 499.88
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 86
|
—
|
—
|
551.3 titers
Standard Deviation 242.88
|
1479.3 titers
Standard Deviation 2024.13
|
1535.0 titers
Standard Deviation 1004.73
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 209
|
—
|
—
|
59.0 titers
|
474.7 titers
Standard Deviation 799.09
|
396.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 394
|
—
|
—
|
29.0 titers
|
2556.0 titers
Standard Deviation 2736.07
|
204.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Baseline
|
30.7 titers
Standard Deviation 20.15
|
130.8 titers
Standard Deviation 287.88
|
204.6 titers
Standard Deviation 89.47
|
939.4 titers
Standard Deviation 1439.18
|
1111.3 titers
Standard Deviation 817.14
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 113
|
505.0 titers
Standard Deviation 364.87
|
455.0 titers
Standard Deviation 232.27
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 142
|
743.3 titers
Standard Deviation 455.08
|
312.5 titers
Standard Deviation 26.16
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 180
|
543.0 titers
Standard Deviation 332.50
|
8896.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 209
|
—
|
—
|
859.5 titers
Standard Deviation 211.42
|
463.0 titers
Standard Deviation 1029.03
|
2272.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 15
|
—
|
—
|
4.0 titers
Standard Deviation 230.52
|
383.3 titers
Standard Deviation 577.54
|
30.3 titers
Standard Deviation 277.62
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 86
|
—
|
—
|
5854.3 titers
Standard Deviation 9508.49
|
1361.3 titers
Standard Deviation 1933.56
|
633.0 titers
Standard Deviation 405.82
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 113
|
568.3 titers
Standard Deviation 432.60
|
683.7 titers
Standard Deviation 466.31
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 86
|
—
|
—
|
12417.2 titers
Standard Deviation 28027.00
|
9031.7 titers
Standard Deviation 9679.50
|
1252.7 titers
Standard Deviation 1158.66
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 478
|
1059.0 titers
|
163.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 180
|
1110.0 titers
Standard Deviation 732.28
|
4826.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 209
|
—
|
—
|
394.0 titers
|
-295.7 titers
Standard Deviation 1059.91
|
-103.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 293
|
774.0 titers
Standard Deviation 15.56
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 365
|
508.0 titers
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 394
|
—
|
—
|
310.0 titers
|
1800.3 titers
Standard Deviation 3177.44
|
-428.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 180
|
700.3 titers
Standard Deviation 1330.07
|
9089.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 209
|
—
|
—
|
9643.0 titers
|
906.0 titers
Standard Deviation 419.01
|
8843.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 293
|
1282.0 titers
Standard Deviation 944.69
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 365
|
758.0 titers
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Alpha Variant : Change at Day 394
|
—
|
—
|
2430.0 titers
|
3497.0 titers
Standard Deviation 4154.15
|
1441.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 29
|
2736.7 titers
Standard Deviation 2296.58
|
5698.4 titers
Standard Deviation 8043.68
|
7199.6 titers
Standard Deviation 20163.93
|
1520.0 titers
Standard Deviation 1481.62
|
403.0 titers
Standard Deviation 492.63
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 57
|
3069.6 titers
Standard Deviation 3084.54
|
6195.9 titers
Standard Deviation 11607.01
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike WT Variant : Change at Day 58
|
—
|
—
|
27494.5 titers
Standard Deviation 60940.14
|
11316.4 titers
Standard Deviation 15472.50
|
1684.3 titers
Standard Deviation 1330.26
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 29
|
620.2 titers
Standard Deviation 359.53
|
1645.0 titers
Standard Deviation 2331.97
|
946.0 titers
Standard Deviation 1918.04
|
438.0 titers
Standard Deviation 923.19
|
120.7 titers
Standard Deviation 298.41
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 57
|
938.2 titers
Standard Deviation 483.10
|
1651.0 titers
Standard Deviation 2729.72
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 113
|
541.0 titers
Standard Deviation 442.36
|
531.0 titers
Standard Deviation 255.69
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 142
|
599.3 titers
Standard Deviation 426.48
|
608.0 titers
Standard Deviation 445.48
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 180
|
473.0 titers
Standard Deviation 187.93
|
4357.0 titers
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 293
|
360.0 titers
Standard Deviation 77.78
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Beta Variant : Change at Day 365
|
353.0 titers
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 15
|
—
|
—
|
66.5 titers
Standard Deviation 72.83
|
556.0 titers
Standard Deviation 903.70
|
35.7 titers
Standard Deviation 169.21
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 29
|
881.7 titers
Standard Deviation 463.61
|
2620.2 titers
Standard Deviation 4221.31
|
2190.8 titers
Standard Deviation 4501.32
|
441.2 titers
Standard Deviation 598.52
|
72.0 titers
Standard Deviation 263.90
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 57
|
1346.5 titers
Standard Deviation 1108.33
|
3149.2 titers
Standard Deviation 6124.92
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 58
|
—
|
—
|
5775.0 titers
Standard Deviation 10376.28
|
1591.0 titers
Standard Deviation 1515.13
|
202.7 titers
Standard Deviation 76.05
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 86
|
—
|
—
|
2020.5 titers
Standard Deviation 2913.95
|
861.0 titers
Standard Deviation 1075.02
|
1040.7 titers
Standard Deviation 1058.26
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 293
|
359.5 titers
Standard Deviation 6.36
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 365
|
361.0 titers
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Delta Variant : Change at Day 394
|
—
|
—
|
1478.5 titers
Standard Deviation 437.70
|
2093.7 titers
Standard Deviation 2175.41
|
2571.0 titers
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Baseline
|
42.2 titers
Standard Deviation 19.02
|
64.8 titers
Standard Deviation 118.26
|
751.8 titers
Standard Deviation 638.95
|
1823.0 titers
Standard Deviation 2042.95
|
1387.7 titers
Standard Deviation 836.53
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 29
|
1595.7 titers
Standard Deviation 1258.32
|
2597.3 titers
Standard Deviation 4419.00
|
6524.3 titers
Standard Deviation 12990.41
|
643.8 titers
Standard Deviation 722.95
|
668.7 titers
Standard Deviation 654.71
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 57
|
1824.8 titers
Standard Deviation 1702.96
|
3001.5 titers
Standard Deviation 5634.38
|
—
|
—
|
—
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 58
|
—
|
—
|
12835.0 titers
Standard Deviation 21500.00
|
2440.7 titers
Standard Deviation 1763.62
|
549.7 titers
Standard Deviation 905.99
|
|
Change From Baseline in Neutralizing Antibody (nAb) Levels
Spike Gamma Variant : Change at Day 142
|
979.7 titers
Standard Deviation 1110.39
|
610.0 titers
Standard Deviation 571.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 478 daysPopulation: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
Immunogenicity response defined as \>= 2-fold change in the levels from baseline. Response rate was assessed by Spike IgG wild type and nAb Variants \[wild type, alpha, beta, gamma, delta\]. Number of participants with immunogenicity response at any post-baseline timepoint are provided.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=9 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
IgG WT
|
9 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
nAb Gamma
|
6 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
nAb WT
|
9 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
nAb Alpha
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
nAb Beta
|
6 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Immunogenicity Response by Spike IgG and nAb Variants
nAb Delta
|
6 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478Population: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood. T cell responses to SARS-CoV-2 D614G were assessed via ex vivo IFNγ ELISpot assay (methods). Cells were stimulated with overlapping peptide (OLP) pools containing peptides that were 15 amino acids in length (15mers) and spanning both S subunits (Spike pool 1-2, 3-4 \[S1\], 5-6, and 7-8 \[S2\]).
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=9 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=1 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 8
|
-5.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 41.06
|
-5.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 31.38
|
-19.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 30.81
|
-0.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 1.02
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 29
|
46.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 119.95
|
20.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 37.10
|
30.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 46.61
|
1.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 3.35
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 58
|
—
|
—
|
29.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 34.60
|
9.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 15.25
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 142
|
-13.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 33.61
|
6.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 11.55
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 180
|
1.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 40.66
|
30.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 209
|
—
|
—
|
52.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 84.85
|
7.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 12.99
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 478
|
20.0 Spot Forming Unit (SFU) per 10^6 cells
|
82.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Baseline
|
30.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 19.86
|
51.1 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 37.16
|
69.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 56.35
|
94.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 180.45
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 29
|
24.1 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 38.52
|
16.1 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 31.72
|
34.2 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 52.65
|
21.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 47.63
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 142
|
-5.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 25.02
|
17.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 30.31
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 113
|
4.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 22.16
|
-15.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 36.97
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 142
|
14.2 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 53.70
|
-25.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 43.30
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 180
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
62.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 209
|
—
|
—
|
61.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 76.01
|
-17.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 30.31
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Baseline
|
62.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 61.35
|
62.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 53.93
|
75.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 82.22
|
17.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 7.14
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 113
|
-0.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 37.10
|
1.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 38.65
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 293
|
-2.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 33.63
|
40.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 1_2 : Change at Day 365
|
40.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 293
|
58.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 92.68
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 8
|
10.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 27.79
|
10.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 23.25
|
5.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 27.35
|
-22.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 41.35
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 478
|
225.0 Spot Forming Unit (SFU) per 10^6 cells
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Baseline
|
34.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 32.37
|
33.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 40.51
|
37.2 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 41.18
|
34.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 29.34
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 8
|
11.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 37.03
|
11.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 32.56
|
3.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 20.09
|
-4.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 11.23
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 29
|
17.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 68.54
|
9.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 25.31
|
36.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 36.11
|
23.1 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 36.93
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 3_4 : Change at Day 58
|
—
|
—
|
23.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 29.26
|
2.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 9.25
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 58
|
—
|
—
|
62.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 45.55
|
-3.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 4.47
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 113
|
-7.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 17.18
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 180
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
25.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 209
|
—
|
—
|
75.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 106.07
|
-10.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 10.00
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 293
|
5.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 19.42
|
32.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 5_6 : Change at Day 478
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
|
67.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Baseline
|
20.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 6.94
|
25.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 13.13
|
30.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 22.83
|
16.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 3.06
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 8
|
3.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 9.54
|
52.1 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 88.04
|
-11.6 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 17.27
|
-1.3 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 3.06
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 29
|
8.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 23.37
|
80.4 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 148.42
|
9.2 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 29.18
|
-1.9 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 3.75
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 58
|
—
|
—
|
8.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 17.50
|
-1.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 3.35
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 113
|
-0.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 11.58
|
15.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 42.62
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 142
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 15.25
|
169.2 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 308.28
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 180
|
0.0 Spot Forming Unit (SFU) per 10^6 cells
|
20.0 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 209
|
—
|
—
|
13.8 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 19.45
|
1.7 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 2.89
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 293
|
7.5 Spot Forming Unit (SFU) per 10^6 cells
Standard Deviation 9.01
|
-32.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by Spike Pools (ex Vivo ELISpot)
Spike pool 7_8 : Change at Day 478
|
20.0 Spot Forming Unit (SFU) per 10^6 cells
|
27.5 Spot Forming Unit (SFU) per 10^6 cells
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293, 365, 478Population: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via ex vivo IFNγ ELISpot assay (methods). Responses to Nucleocapsid (Nuc) and open reading frame 3a (ORF3a)/Membrane TCE regions were assessed using OLP pools.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=1 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 58
|
—
|
—
|
4.4 SFU per 10^6 cells
Standard Deviation 16.12
|
3.5 SFU per 10^6 cells
Standard Deviation 7.83
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Baseline
|
—
|
15.0 SFU per 10^6 cells
Standard Deviation 0.00
|
15.0 SFU per 10^6 cells
Standard Deviation 0.00
|
16.3 SFU per 10^6 cells
Standard Deviation 3.06
|
15.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 8
|
—
|
3.6 SFU per 10^6 cells
Standard Deviation 9.45
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
-1.5 SFU per 10^6 cells
Standard Deviation 3.35
|
0.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 29
|
—
|
1.1 SFU per 10^6 cells
Standard Deviation 2.83
|
3.3 SFU per 10^6 cells
Standard Deviation 5.40
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
0.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 58
|
—
|
—
|
3.8 SFU per 10^6 cells
Standard Deviation 7.50
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 113
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 142
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 180
|
—
|
0.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 209
|
—
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
Nuc OLP : Change at Day 293
|
—
|
0.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Baseline
|
—
|
17.9 SFU per 10^6 cells
Standard Deviation 7.56
|
19.4 SFU per 10^6 cells
Standard Deviation 9.04
|
15.0 SFU per 10^6 cells
Standard Deviation 0.00
|
15.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 8
|
—
|
-0.4 SFU per 10^6 cells
Standard Deviation 0.94
|
0.8 SFU per 10^6 cells
Standard Deviation 2.04
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
0.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 29
|
—
|
15.4 SFU per 10^6 cells
Standard Deviation 26.24
|
0.0 SFU per 10^6 cells
Standard Deviation 6.32
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
0.0 SFU per 10^6 cells
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 113
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 142
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 180
|
—
|
47.5 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 209
|
—
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
—
|
|
Change From Baseline in T Cell Response by T Cell Epitope (TCE) Pools (ex Vivo ELISpot)
ORF3a/Membrane OLP : Change at Day 293
|
—
|
0.0 SFU per 10^6 cells
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Days 8, 29, 58, 113, 142, 180, 209, 293Population: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
PBMCs were isolated from whole blood. T cell responses to conserved SARS-CoV-2 viral epitopes were assessed via IFNγ ELISpot assay following in vitro stimulation. Responses to Nuc, ORF3a, and membrane TCE regions were assessed using OLP pools.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=2 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 58
|
—
|
—
|
-183.3 SFU per 10^6 cells
Standard Deviation 409.95
|
1482.5 SFU per 10^6 cells
Standard Deviation 2755.78
|
55.0 SFU per 10^6 cells
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 142
|
843.0 SFU per 10^6 cells
Standard Deviation 1741.89
|
281.7 SFU per 10^6 cells
Standard Deviation 617.70
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Baseline
|
502.5 SFU per 10^6 cells
Standard Deviation 609.64
|
1823.6 SFU per 10^6 cells
Standard Deviation 2091.63
|
2292.5 SFU per 10^6 cells
Standard Deviation 2198.52
|
2890.0 SFU per 10^6 cells
Standard Deviation 3792.10
|
10397.5 SFU per 10^6 cells
Standard Deviation 3680.49
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 8
|
-122.5 SFU per 10^6 cells
Standard Deviation 637.16
|
353.6 SFU per 10^6 cells
Standard Deviation 2385.88
|
-1280.8 SFU per 10^6 cells
Standard Deviation 2440.97
|
145.8 SFU per 10^6 cells
Standard Deviation 669.91
|
-4355.0 SFU per 10^6 cells
Standard Deviation 6264.97
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 29
|
206.7 SFU per 10^6 cells
Standard Deviation 498.15
|
-360.8 SFU per 10^6 cells
Standard Deviation 3094.77
|
-541.3 SFU per 10^6 cells
Standard Deviation 479.69
|
371.0 SFU per 10^6 cells
Standard Deviation 2366.67
|
-5890.0 SFU per 10^6 cells
Standard Deviation 8683.27
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 113
|
1341.7 SFU per 10^6 cells
Standard Deviation 1743.64
|
10.0 SFU per 10^6 cells
Standard Deviation 748.55
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 142
|
656.7 SFU per 10^6 cells
Standard Deviation 772.89
|
655.0 SFU per 10^6 cells
Standard Deviation 1079.11
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 180
|
—
|
140.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 209
|
—
|
—
|
2487.5 SFU per 10^6 cells
Standard Deviation 3744.13
|
-615.0 SFU per 10^6 cells
Standard Deviation 466.69
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Nuc OLP : Change at Day 293
|
315.0 SFU per 10^6 cells
Standard Deviation 1154.69
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Baseline
|
472.1 SFU per 10^6 cells
Standard Deviation 485.03
|
695.8 SFU per 10^6 cells
Standard Deviation 1328.89
|
364.0 SFU per 10^6 cells
Standard Deviation 355.17
|
298.8 SFU per 10^6 cells
Standard Deviation 249.21
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 8
|
-125.0 SFU per 10^6 cells
Standard Deviation 441.99
|
-555.0 SFU per 10^6 cells
Standard Deviation 1544.96
|
163.0 SFU per 10^6 cells
Standard Deviation 560.80
|
66.3 SFU per 10^6 cells
Standard Deviation 101.93
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 29
|
-81.4 SFU per 10^6 cells
Standard Deviation 425.82
|
126.3 SFU per 10^6 cells
Standard Deviation 259.27
|
-86.3 SFU per 10^6 cells
Standard Deviation 248.04
|
111.3 SFU per 10^6 cells
Standard Deviation 105.39
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 58
|
—
|
—
|
-15.0 SFU per 10^6 cells
Standard Deviation 232.86
|
155.0 SFU per 10^6 cells
Standard Deviation 330.95
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 113
|
170.0 SFU per 10^6 cells
Standard Deviation 604.78
|
0.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 142
|
211.0 SFU per 10^6 cells
Standard Deviation 446.86
|
68.3 SFU per 10^6 cells
Standard Deviation 70.06
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 180
|
—
|
495.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 209
|
—
|
—
|
0.0 SFU per 10^6 cells
Standard Deviation 0.00
|
-340.0 SFU per 10^6 cells
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
ORF3a OLP : Change at Day 293
|
-385.0 SFU per 10^6 cells
Standard Deviation 544.47
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Baseline
|
993.6 SFU per 10^6 cells
Standard Deviation 1190.16
|
347.5 SFU per 10^6 cells
Standard Deviation 270.40
|
1277.0 SFU per 10^6 cells
Standard Deviation 2005.93
|
645.0 SFU per 10^6 cells
Standard Deviation 434.40
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 8
|
152.5 SFU per 10^6 cells
Standard Deviation 608.04
|
235.8 SFU per 10^6 cells
Standard Deviation 1078.42
|
1794.0 SFU per 10^6 cells
Standard Deviation 3722.19
|
1846.3 SFU per 10^6 cells
Standard Deviation 2972.90
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 29
|
-95.0 SFU per 10^6 cells
Standard Deviation 1336.77
|
1041.3 SFU per 10^6 cells
Standard Deviation 882.95
|
-190.0 SFU per 10^6 cells
Standard Deviation 299.14
|
1290.0 SFU per 10^6 cells
Standard Deviation 2321.25
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 58
|
—
|
—
|
973.3 SFU per 10^6 cells
Standard Deviation 848.27
|
2308.3 SFU per 10^6 cells
Standard Deviation 4019.82
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 113
|
281.0 SFU per 10^6 cells
Standard Deviation 1127.42
|
0.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 180
|
—
|
1075.0 SFU per 10^6 cells
|
—
|
—
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 209
|
—
|
—
|
125.0 SFU per 10^6 cells
Standard Deviation 176.78
|
-820.0 SFU per 10^6 cells
|
—
|
|
Change From Baseline in Immunogenicity Response by TCE Pools (in Vitro Stimulation)
Membrane OLP : Change at Day 293
|
-280.0 SFU per 10^6 cells
Standard Deviation 1909.19
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 478 daysPopulation: Participants in immunogenicity analysis population with available data were analyzed. Data from timepoints collected after reported COVID-19 diagnosis or receipt of external vaccine were excluded.
T cell responses to SARS-CoV-2 D614G and conserved non-Spike epitopes were assessed via ex vivo IFNγ ELISpot assay (methods) using OLP pools containing peptides that were 15 amino acids in length and spanning both S subunits (Spike pool 1-2, 3-4 \[S1\], 5-6, and 7-8 \[S2\]) and TCE regions Nuc and ORF3a/Membrane. Immunogenicity response was defined as \>= 2-fold change in levels from baseline. Response rate to both Spike pools (Spike pool 1-2, 3-4, 5-6, and 7-8) and TCE pools (Nuc OLP and ORF3a/Membrane OLP) was assessed.
Outcome measures
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=9 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 Participants
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=8 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=6 Participants
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=1 Participants
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
Spike Pool 1_2
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
Spike Pool 3_4
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
Spike Pool 5_6
|
3 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
Spike Pool 7_8
|
3 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
TCE Pool : Nuc OLP
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immunogenicity Response by Spike Pools and TCE Pools (ex Vivo ELISpot)
TCE Pool : Mem/ORF3a OLP
|
—
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 microgram (µg) intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 participants at risk
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 participants at risk
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Infections and infestations
Pneumonia bacterial
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
Other adverse events
| Measure |
Cohort 1: GRT-R910 10 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 10 microgram (µg) intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 2: GRT-R910 30 µg, Age ≥60 Years (Receipt of AstraZeneca Vaccine)
n=7 participants at risk
Healthy participants of age ≥60 years received prime dose (on Day 1) of GRT-R910 30 µg intramuscularly at least 2 months after receiving a first-generation COVID-19 (AstraZeneca) vaccine primary series. A subset of participants elected to receive a booster vaccination of GRT-R910 10 µg, which was administered 113 days after the prime vaccination. Participants not receiving booster dose were followed for 12 months, and participants receiving booster dose were followed for 16 months.
|
Cohort 3: GRT-R910 10 µg, ≥60 Years, (Receipt of AstraZeneca or Janssen COVID-19 Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving an adenoviral COVID-19 (AstraZeneca, Janssen) primary series vaccine. Participants were followed for 13 months.
|
Cohort 4: GRT-R910 10 µg, ≥60 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=10 participants at risk
Healthy participants of age ≥60 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving a messenger ribonucleic acid (mRNA)-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
Cohort 6: GRT-R910 10 µg, ≥18 to ≤59 Years, (Receipt of Pfizer/BioNTech, Moderna COVID-19 Vaccine)
n=3 participants at risk
Healthy participants of age ≥18 to ≤59 years received two doses (Day 1 and Day 29) of GRT-R910 10 µg (homologous prime-boost), at least 2 months after receiving mRNA-based COVID-19 (Pfizer/BioNTech, Moderna) primary series vaccine. Participants were followed for 13 months.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
30.0%
3/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Injection site pain
|
100.0%
10/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
7/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
10/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
10/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Fatigue
|
60.0%
6/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
85.7%
6/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
10/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
80.0%
8/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Feverish (Chills/Sweating)
|
70.0%
7/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
7/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
90.0%
9/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
70.0%
7/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Malaise
|
50.0%
5/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
85.7%
6/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
10/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
90.0%
9/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Headache
|
80.0%
8/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
85.7%
6/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
90.0%
9/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
40.0%
4/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Muscle Pain
|
40.0%
4/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
7/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
80.0%
8/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
50.0%
5/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
100.0%
3/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Arthralgia
|
30.0%
3/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
85.7%
6/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
60.0%
6/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
40.0%
4/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
66.7%
2/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Nausea or Vomiting
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
57.1%
4/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
50.0%
5/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
50.0%
5/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
66.7%
2/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Injection site swelling
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
57.1%
4/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
66.7%
2/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Fever
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
28.6%
2/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
28.6%
2/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
30.0%
3/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Injection site bruising
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
33.3%
1/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
28.6%
2/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
14.3%
1/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/7 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
10.0%
1/10 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
0.00%
0/3 • From first dose to month 16
The Safety Analysis Population will include all participants who received any dose of GRT-R910. AEs were collected as solicited and unsolicited AEs. The preferred term reported as both solicited and unsolicited AEs are presented under more than one system organ class due to the difference in nature of the events.
|
Additional Information
Elizabeth Martin, Vice President, Clinical Development Infectious Disease
Gritstone bio, Inc.
Phone: +1 (877) 520-2233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER