Trial Outcomes & Findings for Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 (NCT NCT04728347)
NCT ID: NCT04728347
Last Updated: 2024-12-30
Results Overview
Solicited local adverse events were defined as pain, tenderness, erythema, or swelling at the injection site. Solicited systemic adverse events were defined as fever, fatigue, headache, chills, nausea, vomiting, diarrhoea, myalgia, and arthralgia. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Up to Day 7 (7 days after vaccine administration)
Results posted on
2024-12-30
Participant Flow
Participant milestones
| Measure |
Cohort 1a
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2 Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
25
|
16
|
|
Overall Study
Received Study Drug in This Study
|
12
|
12
|
0
|
0
|
|
Overall Study
COMPLETED
|
12
|
12
|
24
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1a
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2 Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Overall Study
Sponsor decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
Baseline characteristics by cohort
| Measure |
Cohort 1a
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=25 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=16 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 14.99 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 16.17 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 4.13 • n=4 Participants
|
48.2 years
STANDARD_DEVIATION 14.28 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
65 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
61 Participants
n=21 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
|
|
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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7 (7 days after vaccine administration)Population: Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohort 1b, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02. As pre-specified, data is reported for Cohort 1 only.
Solicited local adverse events were defined as pain, tenderness, erythema, or swelling at the injection site. Solicited systemic adverse events were defined as fever, fatigue, headache, chills, nausea, vomiting, diarrhoea, myalgia, and arthralgia. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1a
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Events
Solicited Local
|
11 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Solicited Local and Systemic Adverse Events
Solicited Systemic
|
11 Participants
|
8 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29 (28 days after vaccine administration)Population: Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohort 1b, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02. As pre-specified, data is reported for Cohort 1 only.
Unsolicited adverse events were defined as any spontaneously occurring adverse event (serious and non-serious). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1a
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
3 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to a maximum of approximately 12 monthsPopulation: Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A NOCD was defined as a MAAE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. A MAAE was an adverse event that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Cohort 1a
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=25 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=16 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs)
SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs)
Unsolicited Adverse Events Associated with NOCD
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs)
MAAEs
|
2 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 who had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=19 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=3 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies
Day 1
|
5.0 Titer
Interval 5.0 to 5.0
|
7.3 Titer
Interval 3.14 to 16.99
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies
Day 29
|
6.1 Titer
Interval 4.46 to 8.41
|
38.6 Titer
Interval 12.1 to 123.12
|
9.7 Titer
Interval 4.28 to 21.75
|
5.0 Titer
Interval 5.0 to 5.0
|
|
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies
Day 57
|
5.7 Titer
Interval 4.28 to 7.45
|
23.5 Titer
Interval 7.65 to 71.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=19 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=3 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers
Day 57
|
1.1 Ratio
Interval 0.86 to 1.49
|
3.6 Ratio
Interval 1.42 to 9.33
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers
Day 1
|
—
|
0.9 Ratio
Interval 0.71 to 1.07
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers
Day 29
|
1.2 Ratio
Interval 0.89 to 1.68
|
4.3 Ratio
Interval 1.71 to 10.88
|
1.6 Ratio
Interval 0.49 to 5.48
|
1.0 Ratio
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Days 29, and 57Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
Seroconversion was defined as a 4-fold increase in antibody titer/concentration from baseline. Data is presented for the number of participants seroconverting for neutralizing antibodies and immunoglobulin G (IgG) antibodies against the full-length SARS-CoV-2 recombinant spike protein antigen and spike protein receptor binding domain of the SARS-CoV-2 spike glycoprotein (RBD). ARCT-021-naïve participants were those participants whose first ARCT-021 vaccine administration occurred in this study (Cohort 1a). As pre-specified, data is presented for participants in Cohort 1a only.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies)
Day 29
|
1 Participants
|
—
|
—
|
—
|
|
Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Neutralizing Antibodies)
Day 57
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1a and 1b: Days 1, 29, 57, Cohort 2: Day 29Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 who had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
GMC data are reported for the S (spike binding antibodies) analyte.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=19 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=3 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies
Day 57
|
1013.5 Arbitrary units per milliliter (AU/mL)
Interval 501.13 to 2049.58
|
3088.1 Arbitrary units per milliliter (AU/mL)
Interval 1172.0 to 8136.75
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies
Day 1
|
47.3 Arbitrary units per milliliter (AU/mL)
Interval 24.06 to 93.12
|
310.6 Arbitrary units per milliliter (AU/mL)
Interval 90.06 to 1071.18
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Serum SARS-CoV-2 Binding Antibodies
Day 29
|
1629.3 Arbitrary units per milliliter (AU/mL)
Interval 770.41 to 3445.89
|
5319.8 Arbitrary units per milliliter (AU/mL)
Interval 1817.81 to 15568.32
|
802.8 Arbitrary units per milliliter (AU/mL)
Interval 349.23 to 1845.44
|
713.2 Arbitrary units per milliliter (AU/mL)
Interval 178.25 to 2853.69
|
SECONDARY outcome
Timeframe: Cohort 1a: Days 29, 57, Cohort 1b: Days 1, 29, 57, and Cohort 2: Day 29Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
GMFR data are reported for the S (spike binding antibodies) analyte.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=19 Participants
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=3 Participants
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
GMFR in SARS-CoV-2 Binding Antibody Titers
Day 1
|
—
|
7.2 Ratio
Interval 3.83 to 13.45
|
—
|
—
|
|
GMFR in SARS-CoV-2 Binding Antibody Titers
Day 29
|
34.4 Ratio
Interval 16.76 to 70.69
|
136.5 Ratio
Interval 46.58 to 400.08
|
13.3 Ratio
Interval 3.94 to 44.75
|
29.6 Ratio
Interval 15.8 to 55.33
|
|
GMFR in SARS-CoV-2 Binding Antibody Titers
Day 57
|
20.4 Ratio
Interval 10.59 to 39.24
|
104.9 Ratio
Interval 34.62 to 317.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, and 57Population: Immunogenicity population, which included all participants who received Study vaccine in either ARCT-021-01 or ARCT-021-02 and had evaluable immunogenicity data following first vaccine administration. Overall number of participants analyzed' = participants evaluable for endpoint. 'Number analyzed' = participants evaluable at specified timepoint.
Seroconversion was defined as a 4-fold increase in antibody titer/concentration from baseline. Data is presented for the number of participants seroconverting for binding antibodies and immunoglobulin G (IgG) antibodies against the full-length SARS-CoV-2 recombinant spike protein antigen and spike protein receptor binding domain of the SARS-CoV-2 spike glycoprotein (RBD). ARCT-021-naïve participants were those participants whose first ARCT-021 vaccine administration occurred in this study (Cohort 1a). As pre-specified, data is presented for participants in Cohort 1a only.
Outcome measures
| Measure |
Cohort 1a
n=11 Participants
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Binding Antibodies)
Day 29
|
10 Participants
|
—
|
—
|
—
|
|
Number of ARCT-021-naïve Participants (Cohort 1a) With Seroconversion (Binding Antibodies)
Day 57
|
9 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort 1a
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1b
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: Younger Adults
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: Older Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1a
n=12 participants at risk
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 participants at risk
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=25 participants at risk
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=16 participants at risk
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
8.3%
1/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
Other adverse events
| Measure |
Cohort 1a
n=12 participants at risk
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose primary injection of ARCT-021 on Day 1.
|
Cohort 1b
n=12 participants at risk
Participants who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were without detectable neutralizing antibody responses at baseline received a single-dose booster injection of ARCT-021 on Day 1.
|
Cohort 2: Younger Adults
n=25 participants at risk
Participants aged 21 to 55 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
Cohort 2: Older Adults
n=16 participants at risk
Participants aged 56 to 80 years old who participated in Study ARCT-021-01 (the Parent Study \[NCT04480957\]) and were vaccinated with ARCT-021 who did not receive subsequent vaccination with ARCT-021 in this study.
|
|---|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
8.3%
1/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
1/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
8.3%
1/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
4.0%
1/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
4.0%
1/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
4.0%
1/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
4.0%
1/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/12 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
4.0%
1/25 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
0.00%
0/16 • Up to a maximum of approximately 12 months
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported in the Safety population for Cohort 1a, which included all participants who received Study vaccine in ARCT-021-02 only, and in the Longitudinal Safety population for Cohorts 1b and Cohort 2, which included all participants who received Study vaccine in ARCT- 021-01 and ARCT-021-02 (Cohort 1b) or ARCT-021-01 only (Cohort 2).
|
Additional Information
Arcturus Therapeutics, Inc.
Arcturus Therapeutics, Inc.
Phone: 858-900-2660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place