Trial Outcomes & Findings for Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19） (NCT NCT05065619)
NCT ID: NCT05065619
Last Updated: 2023-11-07
Results Overview
Immediate AEs are defined as any solicited AEs and unsolicited AEs occurring within 30 minutes after vaccination. The causal relationship of all solicited AEs to investigational product was analyzed as related.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
128 participants
Primary outcome timeframe
Within 30 minutes after each vaccination
Results posted on
2023-11-07
Participant Flow
Low dose arm is open-label, not randomized arm and was not enrolled. It was described in the protocol that the study may be completed even if fewer than planned number of subjects in Low dose arm are enrolled.
Participant milestones
| Measure |
MT-2766 High Dose (3.75 µg)
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Up to Day 42
STARTED
|
102
|
26
|
|
Up to Day 42
COMPLETED
|
100
|
26
|
|
Up to Day 42
NOT COMPLETED
|
2
|
0
|
|
After Day 43
STARTED
|
100
|
26
|
|
After Day 43
COMPLETED
|
0
|
0
|
|
After Day 43
NOT COMPLETED
|
100
|
26
|
Reasons for withdrawal
| Measure |
MT-2766 High Dose (3.75 µg)
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Up to Day 42
Lost to Follow-up
|
1
|
0
|
|
Up to Day 42
Withdrawal by Subject
|
1
|
0
|
|
After Day 43
Lost to Follow-up
|
1
|
0
|
|
After Day 43
Physician Decision
|
3
|
0
|
|
After Day 43
Withdrawal by Subject
|
1
|
2
|
|
After Day 43
Public vaccination
|
6
|
8
|
|
After Day 43
Difficult to go to the hospital due to moving
|
1
|
0
|
|
After Day 43
Study Terminated by Sponsor
|
88
|
16
|
Baseline Characteristics
Safety Immunogenicity Study of MT-2766 in Japanese Adults（COVID-19）
Baseline characteristics by cohort
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
127 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes after each vaccinationPopulation: Safety population included all randomized subjects who received at least 1 dose of the investigational product.
Immediate AEs are defined as any solicited AEs and unsolicited AEs occurring within 30 minutes after vaccination. The causal relationship of all solicited AEs to investigational product was analyzed as related.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Percentage of Participants with Immediate Solicited AEs
|
11.9 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Solicited AE: Mild
|
11.9 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Solicited AE: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Solicited AE: Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Solicited AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Percentage of Participants with Immediate Unsolicited AE
|
1.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Unsolicited AE: Mild
|
1.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Unsolicited AE: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Unsolicited AE: Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Severity of Immediate Unsolicited AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Immediate Adverse Events (AEs) According to Severity, and Investigator-assessed Causality
Percentage of Participants with Immediate Related Unsolicited AE
|
1.0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days after each vaccinationPopulation: Safety population included all randomized subjects who received at least 1 dose of the investigational product.
Solicited AEs are defined the following; (i) local AEs (injection site erythema, injection site swelling, injection site induration, and injection site pain) and (ii) systemic AEs (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck)．
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Percentage of Participants With Solicited AEs According to Severity
Percentage of Participants with Solicited AE
|
91.1 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited AE: Mild
|
60.4 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited AE: Moderate
|
24.8 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited AE: Severe
|
5.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Percentage of Participants with Solicited Local AE
|
85.1 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Local AE: Mild
|
76.2 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Local AE: Moderate
|
6.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Local AE: Severe
|
2.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Local AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Percentage of Participants with Solicited Systemic AE
|
70.3 percentage of participants
|
38.5 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Systemic AE: Mild
|
45.5 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Systemic AE: Moderate
|
20.8 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Systemic AE: Severe
|
3.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited AEs According to Severity
Severity of Solicited Systemic AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 21 days after each vaccinationPopulation: Safety population included all randomized subjects who received at least 1 dose of the investigational product.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Severity of Unsolicited AE: Severe
|
0.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Percentage of Participants with Unsolicited AEs
|
18.8 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Severity of Unsolicited AE: Mild
|
15.8 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Severity of Unsolicited AE: Moderate
|
3.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Severity of Unsolicited AE: Potentially life-threatening
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Unsolicited AEs According to Severity, and Investigator-assessed Causality
Percentage of Participants with Related Unsolicited AE
|
12.9 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Within 21 days after each vaccinationPopulation: Safety population included all randomized subjects who received at least 1 dose of the investigational product.
AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with SAEs
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with MAAEs
|
3.0 percentage of participants
|
11.5 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with AEs Leading to Study Withdrawal
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with AESIs
|
2.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with Deaths
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections.
Geometric mean neutralizing antibody titer (GMT)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=99 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
GMT: Day 0
|
6.6 titer
Interval 5.5 to 8.0
|
6.9 titer
Interval 4.5 to 10.6
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
GMT: Day 21
|
43.9 titer
Interval 31.9 to 60.3
|
7.0 titer
Interval 4.3 to 11.5
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
GMT: Day 42
|
912.6 titer
Interval 733.6 to 1135.1
|
7.0 titer
Interval 4.5 to 11.0
|
PRIMARY outcome
Timeframe: Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections.
Geometric mean fold rise (GMFR) is defined as the ratio of geometric mean antibody titer (GMT) based on that of Day 0 (i.e. Day 21/Day 0 and Day 42/Day 0).
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=99 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
GMFR: Day 21/Day 0
|
6.55 fold rise
Interval 5.2 to 8.26
|
1.03 fold rise
Interval 0.66 to 1.62
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
GMFR: Day 42/Day 0
|
136.75 fold rise
Interval 112.15 to 166.74
|
1.04 fold rise
Interval 0.71 to 1.54
|
PRIMARY outcome
Timeframe: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections.
Seroconversion (SC) rate. SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with: * For subjects with detectable Nab titer at Day 0 (i.e. baseline Nab titer ≥10): a ≥ 4-fold increase in Nab titers between Day 0 and Day 21/42, respectively. * For subjects with undetectable Nab titer at Day 0 (i.e. baseline Nab titer \< 10): Nab titer of ≥ 40 on Day 21/42, respectively.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=99 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses
Day 21
|
38.9 percentage of subjects achieving SC
Interval 29.1 to 49.5
|
0 percentage of subjects achieving SC
Interval 0.0 to 13.7
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses
Day 42
|
99.0 percentage of subjects achieving SC
Interval 94.4 to 100.0
|
0 percentage of subjects achieving SC
Interval 0.0 to 13.7
|
PRIMARY outcome
Timeframe: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections.
Using the interferon-γ enzyme-linked immunospot (ELISpot) assay. Unit of Measure: Spot-Forming Cell (SFC)/10\^6 Peripheral Blood Mononuclear Cells (PBMC)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=99 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Day 0
|
188.0 SFC/10^6 PBMC
Interval 73.0 to 258.0
|
277.5 SFC/10^6 PBMC
Interval 120.0 to 450.0
|
|
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Day 21
|
265.5 SFC/10^6 PBMC
Interval 128.0 to 635.0
|
330.0 SFC/10^6 PBMC
Interval 233.0 to 465.0
|
|
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
Day 42
|
1173.0 SFC/10^6 PBMC
Interval 1010.0 to 1305.0
|
413.0 SFC/10^6 PBMC
Interval 43.0 to 835.0
|
PRIMARY outcome
Timeframe: Day 0 (before 1st vaccination), Day 21 (21 days after 1st vaccination and before 2nd vaccination), and Day 42 (21 days after 2nd vaccination)Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 21 analysis, this included the subjects who received the first vaccine dose and had Day 0 and Day 21 immunogenicity sample collections. For the Day 42 analysis, this included the subjects who received both vaccine doses and had Day 0 and Day 42 immunogenicity sample collections.
Using the interleukin-4 ELISpot assay
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=99 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Day 0
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 0.0
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 0.0
|
|
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Day 21
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 75.0
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 0.0
|
|
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
Day 42
|
619.0 SFC/10^6 PBMC
Interval 540.0 to 786.0
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.Population: Safety population included all randomized subjects who received at least 1 dose of the investigational product.
AESIs include vaccine-associated enhanced diseases, hypersensitivity reactions, and potential immune-mediated diseases.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with SAEs
|
2.0 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with MAAEs
|
31.7 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with AEs Leading to Study Withdrawal
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with AESIs
|
2.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESIs), and Deaths
Percentage of Participants with Deaths
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22).
Geometric mean neutralizing antibody titer (GMT)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=94 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=25 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
GMT: Day 128
|
196.5 titer
Interval 147.0 to 262.7
|
8.5 titer
Interval 4.6 to 15.8
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMT
GMT: Day 201
|
139.9 titer
Interval 99.5 to 196.8
|
8.3 titer
Interval 4.2 to 16.4
|
SECONDARY outcome
Timeframe: Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22).
Geometric mean fold rise (GMFR)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=94 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=25 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
GMFR: Day 128/Day 0
|
29.17 fold rise
Interval 22.6 to 37.65
|
1.22 fold rise
Interval 0.74 to 2.0
|
|
SARS-CoV-2 Neutralizing Antibody (Nab) Responses: GMFR
GMFR: Day 201/Day 0
|
22.63 fold rise
Interval 16.55 to 30.94
|
1.17 fold rise
Interval 0.62 to 2.21
|
SECONDARY outcome
Timeframe: Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 128, analysis included the subjects who received both doses and had Day 0 and 128 sample collections (MT-2766 n=94, Placebo n=25). For the Day 201, analysis included the subjects who received both doses and had Day 0 and 201 sample collections (MT-2766 n=90, Placebo n=22).
SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with: * For subjects with detectable Nab titer at Day 0 (i.e. baseline Nab titer ≥10): a ≥ 4-fold increase in Nab titers between Day 0 and Day 128/201, respectively. * For subjects with undetectable Nab titer at Day 0 (i.e. baseline Nab titer \< 10): Nab titer of ≥ 40 on Day 128/201, respectively.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=94 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=25 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody
SC rate: Day 128
|
90.4 ％
Interval 82.6 to 95.5
|
4.0 ％
Interval 0.1 to 20.4
|
|
Seroconversion (SC) Rate of SARS-CoV-2 Neutralizing Antibody
SC rate: Day 201
|
77.8 ％
Interval 67.8 to 85.9
|
4.5 ％
Interval 0.1 to 22.8
|
SECONDARY outcome
Timeframe: Days 201Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 128 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 128 immunogenicity sample collections. For the Day 201 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 201 immunogenicity sample collections.
Using the interferon-γ enzyme-linked immunospot (ELISpot) assay.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=85 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=18 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific T Helper 1 (Th1) Cell-mediated Immune (CMI) Responses
|
948.0 SFC/10^6 PBMC
Interval 815.0 to 1103.0
|
171.50 SFC/10^6 PBMC
Interval 0.0 to 295.0
|
SECONDARY outcome
Timeframe: Days 201Population: Immunogenicity Per Protocol population included all randomized subjects who do not have any major protocol violations, and who received the investigational product. For the Day 128 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 128 immunogenicity sample collections. For the Day 201 analysis, this should include the subjects who received both vaccine doses and had Day 0 and Day 201 immunogenicity sample collections.
Using the interleukin-4 ELISpot assay
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=87 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=19 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific T Helper 2 (Th2) CMI Responses
|
375.0 SFC/10^6 PBMC
Interval 302.0 to 516.0
|
0.0 SFC/10^6 PBMC
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0，Day 21，Day 42，Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point.
Geometric mean neutralizing antibody titer (GMT)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=100 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
GMT: Day 0
|
103.6 titer
Interval 72.8 to 147.6
|
119.5 titer
Interval 52.5 to 271.7
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
GMT: Day 21
|
2258.3 titer
Interval 1529.5 to 3334.3
|
118.6 titer
Interval 52.1 to 270.0
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
GMT: Day 42
|
95159.8 titer
Interval 78038.0 to 116038.2
|
114.3 titer
Interval 50.6 to 257.9
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
GMT: Day 128
|
24391.9 titer
Interval 17875.1 to 33284.5
|
147.0 titer
Interval 59.4 to 363.7
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMT
GMT: Day 201
|
15429.0 titer
Interval 10934.6 to 21770.8
|
216.6 titer
Interval 80.2 to 584.7
|
SECONDARY outcome
Timeframe: Day 0，Day 21，Day 42，Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point.
Geometric mean fold rise (GMFR)
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=98 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
GMFR: Day 201/Day 0
|
176.32 fold rise
Interval 125.47 to 247.77
|
1.95 fold rise
Interval 0.98 to 3.9
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
GMFR: Day 21/Day 0
|
22.34 fold rise
Interval 16.94 to 29.47
|
1.02 fold rise
Interval 0.6 to 1.75
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
GMFR: Day 42/Day 0
|
917.37 fold rise
Interval 738.51 to 1139.54
|
1.03 fold rise
Interval 0.67 to 1.57
|
|
SARS-CoV-2-specific Antibody Responses (Total IgG): GMFR
GMFR: Day 128/Day 0
|
245.38 fold rise
Interval 181.54 to 331.67
|
1.34 fold rise
Interval 0.75 to 2.38
|
SECONDARY outcome
Timeframe: Day 0，Day 21，Day 42，Day 128 and Day 201Population: This analysis population included randomized subjects who had no major protocol violations and received investigational drug (MT-2766 n=100, Placebo n=26). For the Day 21, analysis included the subjects who received the 1st dose and had Day 0 and 21 sample collections. For the Day 42, 128, and 201, analyses included the subjects who received two doses and had Day 0 and the each time point sample collections. See the table below for the number of analyzed subjects at each time point.
SC rate is defined as the proportion of subjects achieving SC in the analysis set i.e. subjects with: * For subjects with detectable Nab titer at Day 0 (i.e. baseline Nab titer ≥10): a ≥ 4-fold increase in Nab titers between Day 0 and Day 21/42/128/201, respectively. * For subjects with undetectable Nab titer at Day 0 (i.e. baseline Nab titer \< 10): Nab titer of ≥ 40 on Day 21/42, respectively.
Outcome measures
| Measure |
MT-2766 High Dose (3.75 µg)
n=98 Participants
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 Participants
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
SC rate: Day 21
|
83.7 percentage of subjects achieving SC
Interval 74.8 to 90.4
|
0.0 percentage of subjects achieving SC
Interval 0.0 to 13.2
|
|
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
SC rate: Day 42
|
97.9 percentage of subjects achieving SC
Interval 92.7 to 99.7
|
0.0 percentage of subjects achieving SC
Interval 0.0 to 13.7
|
|
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
SC rate: Day 128
|
96.8 percentage of subjects achieving SC
Interval 91.0 to 99.3
|
11.5 percentage of subjects achieving SC
Interval 2.4 to 30.2
|
|
Seroconversion (SC) Rate of SARS-CoV-2-specific Antibody Responses (Total IgG):
SC rate: Day 201
|
95.6 percentage of subjects achieving SC
Interval 89.0 to 98.8
|
18.2 percentage of subjects achieving SC
Interval 5.2 to 40.3
|
Adverse Events
MT-2766 High Dose (3.75 µg)
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 participants at risk
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 participants at risk
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
3.8%
1/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Nervous system disorders
Cerebral infarction
|
0.99%
1/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.99%
1/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
3.8%
1/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
Other adverse events
| Measure |
MT-2766 High Dose (3.75 µg)
n=101 participants at risk
Subjects received two doses of MT-2766 high dose (3.75 µg) given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
Placebo
n=26 participants at risk
Subjects received two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once).
|
|---|---|---|
|
General disorders
Induration
|
35.6%
36/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Pain
|
83.2%
84/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
11.5%
3/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Skin and subcutaneous tissue disorders
Redness
|
11.9%
12/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Chills
|
43.6%
44/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
3.8%
1/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Fatigue
|
49.5%
50/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
23.1%
6/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Feeling of General Discomfort
|
38.6%
39/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
19.2%
5/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Feeling of Swelling in the Neck
|
8.9%
9/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
3.8%
1/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Fever
|
14.9%
15/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Nervous system disorders
Headache
|
46.5%
47/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
19.2%
5/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Musculoskeletal and connective tissue disorders
Joint Aches
|
27.7%
28/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
3.8%
1/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
43.6%
44/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
|
General disorders
Swelling
|
29.7%
30/101 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
0.00%
0/26 • Day 0 (after 1st vaccination) to end of study, on average the study duration by the termination is 334 days.
Data were collected based on regular investigator assessment and laboratory testing, self-reporting by participants and subject diary. For solicited AEs, prespecified AEs were collected up to 7 days after each administration using the subject diary.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER