Trial Outcomes & Findings for A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1) (NCT NCT04830800)
NCT ID: NCT04830800
Last Updated: 2025-02-13
Results Overview
Percentage of participants with solicited local and systemic adverse events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
During the first 7 days after each vaccination
Results posted on
2025-02-13
Participant Flow
The screening and enrollment were conducted from 10 Mar 2021 to 17 April 2021 at the clinical trial center of Hanoi Medical University. Total 224 subjects were screened, and 120 subjects were randomized to 5 treatment arms (25 for each of 4 study vaccine doses/formulation and 20 for placebo cohort).
This is a first-in-human with dose escalation. There are 4 groups, each group (25 subjects for each vaccine dose/formulation + 5 subject of placebo cohort) will be divided into two sequential subgroups, a sentinel subgroup (n=6) and a larger subgroup (n=24) that includes the remaining subjects to be evaluated at that dose level (or for that formulation in the case of the one adjuvanted treatment group).
Participant milestones
| Measure |
COVIVAC 1mcg
1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 3mcg
3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 10mcg
10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 1mcg + CpG1018 1.5mg
1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
Placebo
Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Phosphate-buffered saline: Phosphate buffer solution (pH 7.2), manufactured by IVAC
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
25
|
20
|
|
Overall Study
At 14 Days After Second Vaccination
|
25
|
25
|
25
|
25
|
20
|
|
Overall Study
At Day 197 (6 Months After Second Vaccination)
|
23
|
24
|
25
|
24
|
20
|
|
Overall Study
COMPLETED
|
23
|
24
|
25
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
COVIVAC 1mcg
1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 3mcg
3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 10mcg
10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 1mcg + CpG1018 1.5mg
1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
Placebo
Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Phosphate-buffered saline: Phosphate buffer solution (pH 7.2), manufactured by IVAC
|
|---|---|---|---|---|---|
|
Overall Study
4 subject was missing value at visit 7 (Day 197) due to migrated/moved from the study area.
|
2
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1)
Baseline characteristics by cohort
| Measure |
COVIVAC 1mcg
n=25 Participants
1mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 3mcg
n=25 Participants
3mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 10mcg
n=25 Participants
10mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
COVIVAC 1mcg + CpG1018 1.5mg
n=25 Participants
1mcg + CpG1018 IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC: COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
|
Placebo
n=20 Participants
Phosphate buffered saline (pH 7.2) for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
Phosphate-buffered saline: Phosphate buffer solution (pH 7.2), manufactured by IVAC
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
34.4 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
36.7 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
34.3 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
35.1 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
32.4 Years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
34.7 Years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
20 participants
n=21 Participants
|
120 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Kinh (Ethnicity)
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
19 participants
n=21 Participants
|
117 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other (Ethnicity)
|
00 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Region of Enrollment
Vietnam
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
20 participants
n=21 Participants
|
120 participants
n=8 Participants
|
|
BMI
|
22.1 kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 2.1 • n=7 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 2.5 • n=5 Participants
|
22.3 kg/m^2
STANDARD_DEVIATION 2.4 • n=4 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 2.7 • n=21 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 2.5 • n=8 Participants
|
PRIMARY outcome
Timeframe: During the first 7 days after each vaccinationPopulation: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population.
Percentage of participants with solicited local and systemic adverse events (AEs)
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Solicited Adverse Events
|
88.0 percent of participants
Interval 68.8 to 97.5
|
88.0 percent of participants
Interval 68.8 to 97.5
|
68.0 percent of participants
Interval 46.5 to 85.1
|
80.0 percent of participants
Interval 59.3 to 93.2
|
70.0 percent of participants
Interval 45.7 to 88.1
|
PRIMARY outcome
Timeframe: At 7 days post each vaccinationPopulation: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population
Percentage of participants with clinically significant hematological and biochemical abnormalities
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Clinical Safety Tests
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
0 percent of participants
|
PRIMARY outcome
Timeframe: During the first 28 days after each vaccinationPopulation: All participants receiving at least one dose of study vaccine/placebo will be included in the safety analysis population
Number of participants with any unsolicited adverse event
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Unsolicited Adverse Events
|
48.0 percent of participants
Interval 27.8 to 68.7
|
44.0 percent of participants
Interval 24.4 to 65.1
|
32.0 percent of participants
Interval 14.9 to 53.5
|
52.0 percent of participants
Interval 31.3 to 72.2
|
45.0 percent of participants
Interval 23.1 to 68.5
|
PRIMARY outcome
Timeframe: Throughout the Study Period (until Day 197)Population: There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm)
Number of participants with serious adverse events (SAEs)
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Serious Adverse Event
|
0.0 percent of participants
Interval 0.0 to 13.7
|
0.0 percent of participants
Interval 0.0 to 13.7
|
0.0 percent of participants
Interval 0.0 to 13.7
|
4.0 percent of participants
Interval 0.1 to 20.4
|
5.0 percent of participants
Interval 0.1 to 24.9
|
PRIMARY outcome
Timeframe: Throughout the Study Period (until Day 197)Population: There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm).
Number of participants with medically-attended AEs (MAAEs)
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Medical Attended Adverse Events
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Throughout the Study Period (until Day 197)Population: There are 116 subject attended the follow-up visit day 197 (23 subjects in 1mcg arm, 24 subjects in 3mcg arm, 25 subjects in 10mcg arm, 24 subjects in 1mcg + CpG arm, and 20 subjects in placebo arm).
Number of participants with adverse events of special interest (AESI) , including AESI relevant to COVID-19, and potential immune-mediated medical conditions (PIMMC)
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Adverse Event of Special Interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: GMT of NT50 at 28 days after first vaccination, at 14 days and 6 months after the second vaccinationPopulation: NT50 GMTs are analyzed from subjects with seronegative anti-S IgG at baseline. There were 5 subjects with sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), 2 subjects (1 μg) with invalid result (IR) at visit 3 (Day 29), 8 subjects missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient).
50% neutralizing antibody (NT50) geometric mean titer (GMT) against SARS-CoV-2 pseudovirus
Outcome measures
| Measure |
COVIVAC 10 mcg
n=24 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=24 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=17 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
GMT of 50% Neutralizing Antibody (NT50)
GMT of NT50 at 28 days after first vaccination
|
23.50 IU/ml
Interval 14.91 to 37.02
|
10.67 IU/ml
Interval 6.98 to 16.31
|
8.48 IU/ml
Interval 6.63 to 10.85
|
9.35 IU/ml
Interval 6.29 to 13.89
|
5.00 IU/ml
All participants in placebo cohort had titer less than 10 and were assigned titer of 5. Then 95%CI had not been calculated for all assigned titers.
|
|
GMT of 50% Neutralizing Antibody (NT50)
GMT of NT50 at 14 days after second vaccination
|
460.87 IU/ml
Interval 284.49 to 746.58
|
104.96 IU/ml
Interval 69.29 to 159.0
|
170.24 IU/ml
Interval 119.11 to 243.32
|
268.32 IU/ml
Interval 175.99 to 409.07
|
5.00 IU/ml
All participants in placebo cohort had titer less than 10 and were assigned titer of 5. Then 95%CI had not been calculated for all assigned titers.
|
|
GMT of 50% Neutralizing Antibody (NT50)
GMT of NT50 at 6 months after second vaccination
|
556.25 IU/ml
Interval 237.39 to 1303.36
|
230.72 IU/ml
Interval 75.92 to 701.16
|
607.00 IU/ml
Interval 254.44 to 1448.11
|
452.35 IU/ml
Interval 182.87 to 1118.91
|
20.27 IU/ml
Interval 11.54 to 35.58
|
SECONDARY outcome
Timeframe: GMFR at 28 days after first vaccination, at 14 days and 6 months after the second vaccinationPopulation: There are 2 subjects (1 μg) were invalid result (IR) at visit 3 (Day 29), 8 subjects were missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient).
Geometric mean fold rise (GMFR) (from baseline) in NT50 against SARS-CoV-2 pseudovirus
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR)
GMFR at 28 after first vaccination
|
4.91 fold rise
Interval 3.15 to 7.66
|
2.06 fold rise
Interval 1.37 to 3.11
|
1.70 fold rise
Interval 1.33 to 2.17
|
1.87 fold rise
Interval 1.26 to 2.78
|
1.00 fold rise
All participants in placebo cohort had titer less than 10 and were assigned titer of 5. Then 95%CI had not been calculated for all assigned titers.
|
|
Geometric Mean Fold Rise (GMFR)
GMFR at 14 days after first vaccination
|
84.75 fold rise
Interval 51.76 to 138.77
|
22.50 fold rise
Interval 13.74 to 30.6
|
34.05 fold rise
Interval 23.82 to 48.66
|
53.66 fold rise
Interval 35.2 to 81.81
|
1.00 fold rise
All participants in placebo cohort had titer less than 10 and were assigned titer of 5. Then 95%CI had not been calculated for all assigned titers.
|
|
Geometric Mean Fold Rise (GMFR)
GMFR at 6 months after second vaccination
|
103.27 fold rise
Interval 45.14 to 263.28
|
49.53 fold rise
Interval 17.04 to 143.93
|
121.40 fold rise
Interval 50.89 to 289.62
|
90.47 fold rise
Interval 36.57 to 223.78
|
4.42 fold rise
Interval 2.68 to 7.28
|
SECONDARY outcome
Timeframe: Seroresponse at 28 days after first vaccination, at 14 days and 6 months after the second vaccinationPopulation: NT50 GMTs are analyzed from subjects with seronegative anti-S IgG at baseline. There were 2 subjects (1 μg) with invalid result (IR) at visit 3 (Day 29), 8 subjects missed visit at visit 7 (Day 197), and 1 subject (visit 7 (Day 197)) was not having a sufficient quantity (volume) of specimen to test (QNS- Quantity not sufficient).
Percentage of subjects with NT50 seroresponse against SARS-CoV-2 pseudovirus as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Seroresponse in NT50
Seroresponse at 28 days after first vaccination
|
40.0 percentage of participants
Interval 21.1 to 61.3
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
0.0 percentage of participants
Interval 0.0 to 13.7
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
|
Seroresponse in NT50
Seroresponse at 14 days after second vaccination
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
|
Seroresponse in NT50
Seroresponse at 6 months after second vaccination
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
68.2 percentage of participants
Interval 45.1 to 86.1
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
81.8 percentage of participants
Interval 59.7 to 94.8
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
SECONDARY outcome
Timeframe: GMC of Anti-S IgG at 28 days after the first vaccination, at 14 days and 6 months after the second vaccinationPopulation: GMCs are analyzed from subjects with seronegative anti-S IgG at baseline. There are 5 subjects were sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), and 8 subjects were missed visit at visit 7 (Day 197).
Immunogenicity outcome measurement
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Anti-S IgG GMC
GMC of Anti-S IgG at 28 days after first vaccination
|
29.33 BAU/ml
Interval 19.26 to 44.66
|
9.89 BAU/ml
Interval 6.28 to 15.57
|
15.35 BAU/ml
Interval 11.33 to 20.81
|
6.40 BAU/ml
Interval 4.64 to 8.83
|
3.15 BAU/ml
All participants had titer below the level of detection. GMCs calculation, concentrations of \<10 were assigned as titer of 3.15.
|
|
Anti-S IgG GMC
GMC of Anti-S IgG at 14 days after second vaccination
|
446.50 BAU/ml
Interval 302.6 to 658.83
|
122.54 BAU/ml
Interval 87.06 to 172.48
|
173.38 BAU/ml
Interval 128.12 to 234.61
|
206.51 BAU/ml
Interval 152.89 to 278.93
|
3.15 BAU/ml
All participants had titer below the level of detection. GMCs calculation, concentrations of \<10 were assigned as titer of 3.15.
|
|
Anti-S IgG GMC
GMC of Anti-S IgG at 6 months after second vaccination
|
515.41 BAU/ml
Interval 228.33 to 1163.46
|
242.54 BAU/ml
Interval 129.73 to 909.71
|
469.36 BAU/ml
Interval 178.31 to 1235.52
|
350.79 BAU/ml
Interval 137.91 to 892.26
|
85.98 BAU/ml
Interval 33.22 to 222.51
|
SECONDARY outcome
Timeframe: GMFR at 28 days after the first vaccination, 14 days and 6 months after the second vaccinationPopulation: There are and 8 subjects were missed visit at visit 7 (Day 197).
GMFR (from baseline) in anti-S IgG GMC
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
GMFR in Anti-S IgG GMC
GMFR at 28 days after first vaccination
|
9.14 fold rise
Interval 6.1 to 13.69
|
3.00 fold rise
Interval 1.93 to 4.68
|
4.87 fold rise
Interval 3.59 to 6.61
|
2.03 fold rise
Interval 1.47 to 2.8
|
1.00 fold rise
Interval 0.99 to 1.01
|
|
GMFR in Anti-S IgG GMC
GMFR at 14 days after second vaccination
|
124.11 fold rise
Interval 78.2 to 196.99
|
34.65 fold rise
Interval 23.11 to 51.93
|
55.02 fold rise
Interval 40.66 to 74.46
|
65.54 fold rise
Interval 48.52 to 88.52
|
0.98 fold rise
Interval 0.94 to 1.02
|
|
GMFR in Anti-S IgG GMC
GMFR at 6 months after second vaccination
|
147.60 fold rise
Interval 65.92 to 330.5
|
103.13 fold rise
Interval 40.49 to 262.73
|
148.95 fold rise
Interval 56.59 to 392.1
|
111.33 fold rise
Interval 43.77 to 283.16
|
30.61 fold rise
Interval 13.6 to 68.88
|
SECONDARY outcome
Timeframe: Seroresponse at 28 days after the first vaccination, 14 days and 6 months after the second vaccinationPopulation: There are 8 subjects were missed visit at visit 7 (Day 197).
Percentage of subjects with seroresponses in anti-S IgG titer as defined by (1) a ≥ 4-fold increase from baseline, and (2) a ≥ 10-fold increase from baseline
Outcome measures
| Measure |
COVIVAC 10 mcg
n=25 Participants
All subjects in the exposed population who have no major protocol deviations that are determined to potentially interfere with the immunogenicity assessment of the study product.
|
COVIVAC 1 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 Participants
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Seroresponse in Anti-S IgG Concentration
Seroresponse at 28 days after first vaccination
|
64.0 percentage of participants
Interval 42.5 to 82.0
|
44.2 percentage of participants
Interval 35.1 to 53.5
|
44.0 percentage of participants
Interval 24.4 to 65.1
|
84.0 percentage of participants
Interval 63.9 to 95.5
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
|
Seroresponse in Anti-S IgG Concentration
Seroresponse at 14 days after second vaccination
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
82.5 percentage of participants
Interval 74.5 to 88.8
|
96.0 percentage of participants
Interval 76.9 to 99.9
|
100.0 percentage of participants
Interval 86.3 to 100.0
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
|
Seroresponse in Anti-S IgG Concentration
Seroresponse at 6 months after second vaccination
|
100 percentage of participants
Interval 85.8 to 100.0
|
82.6 percentage of participants
Interval 61.2 to 95.0
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
90.9 percentage of participants
Interval 70.8 to 98.9
|
89.5 percentage of participants
Interval 66.9 to 98.7
|
Adverse Events
COVIVAC 1 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
COVIVAC 3 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
COVIVAC 10 mcg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COVIVAC 1mcg + CpG
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COVIVAC 1 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 10 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Adnexitis
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
5.0%
1/20 • Number of events 1 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
|
Injury, poisoning and procedural complications
COMPLICATED WOUND AT LEFT HAND
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
4.0%
1/25 • Number of events 1 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/20 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
Other adverse events
| Measure |
COVIVAC 1 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 3 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 10 mcg
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
COVIVAC 1mcg + CpG
n=25 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
Placebo
n=20 participants at risk
Participants receiving 2 doses with 28 days apart reporting solicited AEs
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.0%
4/25 • Number of events 4 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
12.0%
3/25 • Number of events 3 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/25 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
8.0%
2/25 • Number of events 2 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
0.00%
0/20 • - Solicited AEs were collected during the 7 days after each vaccination - Unsolicited AEs were collected during the 28 days after each vaccination - MAAEs, AESIs and SAEs were collected from first vaccination until Day 197
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place