Trial Outcomes & Findings for NDV-HXP-S Vaccine Clinical Trial (COVIVAC) (NCT NCT05940194)
NCT ID: NCT05940194
Last Updated: 2025-01-15
Results Overview
* Local solicited AEs: Pain or tenderness, Swelling or induration, Erythema * Systemic solicited AEs: Fever (defined as oral temperature ≥ 38°C), Headache, Fatigue or malaise, Myalgia, Arthralgia, Nausea or vomiting * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
374 participants
Primary outcome timeframe
7 days after each vaccination
Results posted on
2025-01-15
Participant Flow
The screening and enrollment were conducted from 11 Aug 2021 to 23 August 2021 at the District Health Center of Vu Thu district, Thai Binh province. Total 737 subjects were screened, and 374 subjects were randomized to 3 treatment arms (124 subjects in COVIVAC 3µg arm, 125 subjects in COVIVAC 6µg arm and 125 in the AZD122 arm).
This is the phase 2 (part 2) of the phase 1/2 trial of COVIVAC vaccine. After providing informed consent, participants were screened and then randomized to receive either of 2 COVIVAC dose or AZD1222 in the 1:1:1 ratio. Each participant received 2 injections with 28 days apart.
Participant milestones
| Measure |
COVIVAC 3 mcg
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Overall Study
STARTED
|
124
|
125
|
125
|
|
Overall Study
COMPLETED
|
122
|
122
|
121
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
COVIVAC 3 mcg
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Migrated/Moved from the study area
|
2
|
2
|
4
|
Baseline Characteristics
NDV-HXP-S Vaccine Clinical Trial (COVIVAC)
Baseline characteristics by cohort
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.9 Years
STANDARD_DEVIATION 14.82 • n=5 Participants
|
48.9 Years
STANDARD_DEVIATION 14.27 • n=7 Participants
|
49.8 Years
STANDARD_DEVIATION 14.17 • n=5 Participants
|
49.2 Years
STANDARD_DEVIATION 14.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Kinh
|
124 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
373 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
BMI
|
22.29 kg/m^2
STANDARD_DEVIATION 2.67 • n=5 Participants
|
22.27 kg/m^2
STANDARD_DEVIATION 2.52 • n=7 Participants
|
22.24 kg/m^2
STANDARD_DEVIATION 2.55 • n=5 Participants
|
22.27 kg/m^2
STANDARD_DEVIATION 2.57 • n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days after each vaccinationPopulation: All participants received at least one vaccination.
* Local solicited AEs: Pain or tenderness, Swelling or induration, Erythema * Systemic solicited AEs: Fever (defined as oral temperature ≥ 38°C), Headache, Fatigue or malaise, Myalgia, Arthralgia, Nausea or vomiting * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
Any solicited AE after any dose
|
78.2 percent of participants
Interval 69.9 to 85.1
|
80.0 percent of participants
Interval 71.9 to 86.6
|
88.0 percent of participants
Interval 81.0 to 93.1
|
|
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
Mild solicited AE
|
77.4 percent of participants
Interval 69.0 to 84.4
|
78.4 percent of participants
Interval 70.2 to 85.3
|
87.2 percent of participants
Interval 80.0 to 92.5
|
|
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
Moderate solicited AE
|
24.2 percent of participants
Interval 17.0 to 32.7
|
28.0 percent of participants
Interval 20.3 to 36.7
|
46.4 percent of participants
Interval 37.4 to 55.5
|
|
Percentage of Participants With Local and Systemic Solicited AEs by Severity During the First 7 Days After Each Vaccination.
Severe solicited AE
|
1.6 percent of participants
Interval 0.2 to 5.7
|
1.6 percent of participants
Interval 0.2 to 5.7
|
7.2 percent of participants
Interval 3.3 to 13.2
|
PRIMARY outcome
Timeframe: 28 days after each vaccinationPopulation: All participants received at least one vaccination.
* An unsolicited adverse event is any AE reported spontaneously by the subject, observed by the study staff during study visits or those identified during review of medical records or source documents. Solicited AEs with an onset after the seven-day solicitation period will be considered unsolicited AEs * Severity grading: Mild = Causes no or minimal interference with normal daily activities; intervention not indicated; Moderate =Interferes with but does not prevent normal daily activities; intervention indicated; Severe = Prevents normal daily activities; intervention or hospitalization indicated.
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Total unsolicited AE after any dose
|
29.0 percent of participants
Interval 21.2 to 37.9
|
23.2 percent of participants
Interval 16.1 to 31.6
|
31.2 percent of participants
Interval 23.2 to 40.1
|
|
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Mild unsolicited AE
|
10.5 percent of participants
Interval 5.7 to 17.3
|
7.2 percent of participants
Interval 3.3 to 13.2
|
8.8 percent of participants
Interval 4.5 to 15.2
|
|
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Moderate unsolicited AE
|
16.9 percent of participants
Interval 10.8 to 24.7
|
18.4 percent of participants
Interval 12.0 to 26.3
|
23.2 percent of participants
Interval 16.1 to 31.6
|
|
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Severe unsolicited AE
|
3.2 percent of participants
Interval 0.9 to 8.1
|
0.8 percent of participants
Interval 0.0 to 4.4
|
0.8 percent of participants
Interval 0.0 to 4.4
|
|
Percentage of Participants With Unsolicited AEs by Severity and Relatedness During the First 28 Days After Each Vaccination
Related unsolicited AE
|
0.0 percent of participants
Interval 0.0 to 2.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
PRIMARY outcome
Timeframe: From the first vaccination until Day 197Population: All participants received at least one vaccination.
A SAE is a specific AE that: * Results in death. * Is life-threatening.\* * Requires inpatient hospitalization or prolongation of an existing hospitalization.\*\* * Results in a persistent or significant disability or incapacity.\*\*\* * Results in a congenital anomaly or birth defect.
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Participants With SAEs Severity and Relatedness Throughout the Entire Study Period
SAE after any dose
|
2.4 percent of participants
Interval 0.5 to 6.9
|
2.4 percent of participants
Interval 0.5 to 6.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
|
Percentage of Participants With SAEs Severity and Relatedness Throughout the Entire Study Period
Related SAE
|
0.0 percent of participants
Interval 0.0 to 2.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
PRIMARY outcome
Timeframe: From first vaccination to Day 197AEs of Special interest which are AEs relevant to COVID-19 and potential immune-mediated medical conditions (PIMMC) occurred throughout the entire study period
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Participants With AE of Special Interest by Severity and Relatedness Throughout the Entire Study Period
|
0.8 percent of participants
Interval 0.0 to 4.4
|
0.0 percent of participants
Interval 0.0 to 2.9
|
0.0 percent of participants
Interval 0.0 to 2.9
|
PRIMARY outcome
Timeframe: 14 days and 6 months after second vaccinationPopulation: NT50 GMTs are analyzed from subjects with seronegative anti-S IgG at baseline. \- There were 18 subjects were sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), 2 subjects (AstraZeneca) had invalid result (IR) at Baseline (D1), 3 subjects did not received 2nd vaccination, 7 subjects were missed visit (D197), and 4 subjects had invalid result (D197)
NT50 GMT against SARS-CoV-2 pseudovirus in subjects who are anti-S IgG seronegative at baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=120 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=118 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=114 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
NT50 GMT at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
162.78 IU/ml
Interval 136.79 to 193.71
|
200.72 IU/ml
Interval 166.15 to 242.47
|
93.14 IU/ml
Interval 77.7 to 111.66
|
|
NT50 GMT at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
152.38 IU/ml
Interval 91.74 to 253.08
|
132.48 IU/ml
Interval 80.7 to 217.5
|
92.90 IU/ml
Interval 60.28 to 143.18
|
PRIMARY outcome
Timeframe: 14 days and 6 months after second vaccinationPopulation: Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratios of post-vaccination to the pre-first vaccination. The analysis included subjects regardless anti S IgG status at baseline. * Baseline (D1): 2 subjects had invalid result (IR). * Visit 5 (D43): 3 subject (6 μg) did not receive 2nd dose of vaccination. * Visit 7 (D197): 7 subjects were missed visit , 4 subjects had invalid result, 3 subject did not receive 2nd dose of vaccination
GMFR in NT50 against SARS-CoV-2 pseudovirus measured at 14 days and 6 months after second vaccination to the baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=123 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=122 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
GMFR in NT50 at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
33.14 fold rise
Interval 27.82 to 39.47
|
39.93 fold rise
Interval 33.35 to 47.81
|
17.91 fold rise
Interval 14.96 to 21.43
|
|
GMFR in NT50 at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
30.79 fold rise
Interval 18.7 to 50.7
|
28.35 fold rise
Interval 17.67 to 47.11
|
18.69 fold rise
Interval 12.1 to 28.88
|
PRIMARY outcome
Timeframe: 14 days and 6 months after second vaccinationPopulation: Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratios of post-vaccination to the pre-first vaccination. The analysis included subjects regardless anti S IgG status at baseline. * Baseline (D1): 2 subjects had invalid result (IR). * Visit 5 (D43): 3 subject (6 μg) did not receive 2nd dose of vaccination. * Visit 7 (D197): 7 subjects were missed visit , 4 subjects had invalid result, 3 subject did not receive 2nd dose of vaccination
Seroresponses against SARS-CoV-2 pseudovirus as defined by a ≥ 4-fold increase from baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=124 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=123 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=122 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Subjects With Seroresponse in NT50 at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
91.9 percent of participants
Interval 85.7 to 96.1
|
93.5 percent of participants
Interval 87.6 to 97.2
|
82.0 percent of participants
Interval 74.0 to 88.3
|
|
Percentage of Subjects With Seroresponse in NT50 at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
50.8 percent of participants
Interval 41.6 to 60.1
|
47.1 percent of participants
Interval 37.8 to 56.4
|
48.3 percent of participants
Interval 38.9 to 57.7
|
SECONDARY outcome
Timeframe: 14 days and 6 months after the second vaccinationPopulation: IgG GMC are analyzed from subjects with seronegative anti-S IgG at baseline. \- There were 18 subjects were sero-positive at baseline (anti-S IgG ≥50.3 ELU/mL), 2 subjects (AstraZeneca) had invalid result (IR) at Baseline (D1), 3 subjects did not received 2nd vaccination, 7 subjects were missed visit (D197), and 4 subjects had invalid result (D197)
Anti-S IgG GMC in subjects who are anti-S IgG seronegative at baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=120 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=118 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=114 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
IgG GMC at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
141.91 BAU/ml
Interval 118.54 to 169.9
|
176.19 BAU/ml
Interval 144.77 to 214.43
|
348.89 BAU/ml
Interval 294.54 to 413.27
|
|
IgG GMC at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
129.17 BAU/ml
Interval 75.93 to 219.72
|
111.77 BAU/ml
Interval 66.33 to 188.32
|
201.52 BAU/ml
Interval 127.62 to 318.22
|
SECONDARY outcome
Timeframe: 14 days and 6 months after the second vaccinationPopulation: * The analysis included subjects regardless anti S IgG status at baseline. * Baseline (D1): 1 subject had invalid result (IR) of anti-S IgG. * Visit 5 (D43): 1 subject (3 μg) had invalid result (IR) of anti-S IgG at baseline (D1), 3 subjects did not receive 2nd dose of vaccination. * Visit 7 (D197): 1 subject (3 μg) had invalid result (IR) of anti-S IgG at baseline (D1),7 subjects were missed visit, and 2 subjects did not receive 2nd dose of vaccination.
GMFR in anti-S IgG GMC measured at 14 days and 6 months after second vaccination to the baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=123 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=123 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=124 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
GMFR in Anti-S IgG GMC at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
45.13 fold rise
Interval 37.75 to 53.95
|
53.16 fold rise
Interval 43.79 to 64.52
|
100.89 fold rise
Interval 84.9 to 119.9
|
|
GMFR in Anti-S IgG GMC at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
40.38 fold rise
Interval 23.92 to 68.17
|
35.82 fold rise
Interval 21.61 to 59.36
|
60.44 fold rise
Interval 38.86 to 94.0
|
SECONDARY outcome
Timeframe: 14 days and 6 months after the second vaccinationPopulation: * The analysis included subjects regardless anti S IgG status at baseline. * Baseline (D1): 1 subject had invalid result (IR) of anti-S IgG. * Visit 5 (D43): 1 subject (3 μg) had invalid result (IR) of anti-S IgG at baseline (D1), 3 subjects did not receive 2nd dose of vaccination. * Visit 7 (D197): 1 subject (3 μg) had invalid result (IR) of anti-S IgG at baseline (D1),7 subjects were missed visit, and 2 subjects did not receive 2nd dose of vaccination.
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 3 mcg
n=123 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=123 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=124 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Percentage of Subjects With Seroresponses in Anti-S IgG Concentration at 14 Days and 6 Months After Second Vaccination
At 14 days after second vaccination
|
99.2 percent of participants
Interval 95.6 to 100.0
|
96.7 percent of participants
Interval 91.9 to 99.1
|
99.2 percent of participants
Interval 95.6 to 100.0
|
|
Percentage of Subjects With Seroresponses in Anti-S IgG Concentration at 14 Days and 6 Months After Second Vaccination
At 6 months after second vaccination
|
69.4 percent of participants
Interval 60.4 to 77.5
|
77.9 percent of participants
Interval 69.5 to 84.9
|
90 percent of participants
Interval 83.2 to 94.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days and 6 months after the second vaccinationPopulation: One participant missed the D197 visit
Magnitude, functionality, and Th polarization of S protein-specific T cells at 14 days and 6 months after the second vaccination relative to baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=12 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=11 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=13 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
IFN-gamma
SARS-CoV-2 vial 1 - DMSO at 14 days after second vaccination
|
15.00 SFU/1x10^6 cells
Interval 8.0 to 30.0
|
8.00 SFU/1x10^6 cells
Interval 3.0 to 63.0
|
60 SFU/1x10^6 cells
Interval 27.0 to 238.0
|
|
IFN-gamma
SARS-CoV-2 vial 1 - DMSO at 6 months after second vaccination
|
40.00 SFU/1x10^6 cells
Interval 10.0 to 110.0
|
30.00 SFU/1x10^6 cells
Interval 10.0 to 97.0
|
97.00 SFU/1x10^6 cells
Interval 21.0 to 180.0
|
|
IFN-gamma
SARS-CoV-2 vial 2 - DMSO at 14 days after second vaccination
|
16.00 SFU/1x10^6 cells
Interval 3.0 to 33.0
|
11.00 SFU/1x10^6 cells
Interval 0.0 to 33.0
|
70.00 SFU/1x10^6 cells
Interval 20.0 to 187.0
|
|
IFN-gamma
SARS-CoV-2 vial 2 - DMSO at 6 months after second vaccination
|
40.00 SFU/1x10^6 cells
Interval 15.0 to 168.0
|
25.00 SFU/1x10^6 cells
Interval 20.0 to 75.0
|
60.00 SFU/1x10^6 cells
Interval 21.0 to 154.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days and 6 months after second vaccinationPopulation: One participant missed the D197 visit
Magnitude, functionality, and Th polarization of S protein-specific T cells relative to baseline
Outcome measures
| Measure |
COVIVAC 3 mcg
n=12 Participants
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=11 Participants
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=13 Participants
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
IL5
SARS-CoV-2 vial 1 - DMSO at 14 days after second vaccination
|
1.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 5.0
|
|
IL5
SARS-CoV-2 vial 1 - DMSO at 6 months after second vaccination
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 5.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
|
IL5
SARS-CoV-2 vial 2 - DMSO at 14 days after second vaccination
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 0.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 3.0
|
|
IL5
SARS-CoV-2 vial 2 - DMSO at 6 months after second vaccination
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 3.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 2.0
|
0.00 SFU/1x10^6 cells
Interval 0.0 to 0.0
|
Adverse Events
COVIVAC 3 mcg
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
COVIVAC 6 mcg
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
AZD1222
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COVIVAC 3 mcg
n=124 participants at risk
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 participants at risk
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 participants at risk
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
BRAIN CONCUSSION (DUE TO TRAFFIC ACCIDENT)
|
0.81%
1/124 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
STOMACH CANCER
|
0.00%
0/124 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.80%
1/125 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Infections and infestations
COVID-19
|
0.00%
0/124 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.80%
1/125 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/124 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.80%
1/125 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKEMIA
|
0.81%
1/124 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.81%
1/124 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Gastrointestinal disorders
CHRONIC INFLAMMATION OF THE SALIVARY GLANDS
|
0.81%
1/124 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
|
Injury, poisoning and procedural complications
INFECTION AFTER SURGERY
|
0.81%
1/124 • Number of events 1 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
0.00%
0/125 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
Other adverse events
| Measure |
COVIVAC 3 mcg
n=124 participants at risk
3 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
COVIVAC 6 mcg
n=125 participants at risk
6 mcg IVAC COVIVAC vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
AZD1222
n=125 participants at risk
AZD1222 (AstraZeneca) vaccine for intramuscular injection administered as two doses (0.5mL each) 28 days apart.
COVIVAC vaccine: For prevention Covid-19
|
|---|---|---|---|
|
Infections and infestations
Covid-19
|
20.2%
25/124 • Number of events 25 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
17.6%
22/125 • Number of events 22 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
20.0%
25/125 • Number of events 25 • - 7 days after each vaccination for solicited AEs - 28 days after each vaccination for unsolicited AEs - From first vaccination to Day 197 for AE of special interest (AESIs) and SAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place