Trial Outcomes & Findings for ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects (NCT NCT05077267)
NCT ID: NCT05077267
Last Updated: 2024-09-27
Results Overview
The primary endpoint was SARS-CoV-2 index virus neutralizing antibody titers by pseudovirus assay at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3), for subjects in the Immunogenicity Analysis Set.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
197 participants
Primary outcome timeframe
2 weeks after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3)
Results posted on
2024-09-27
Participant Flow
Approximately 210 subjects were to be enrolled in this trial, beginning with a run-in phase of 6 subjects (3 in each of Groups 1 and 2) before enrollment opened to both treatment groups pending positive results from a safety Data Monitoring Committee. Enrollment was based on prior SARS-CoV-2 experience, with Group 1 being seronegative and Group 2 being seropositive. Group 3 was enrolled after completion of the prior groups with a lower dose level for seropositive subjects.
Participant milestones
| Measure |
Group 1
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Treatment Period
STARTED
|
28
|
103
|
66
|
|
Treatment Period
COMPLETED
|
28
|
101
|
66
|
|
Treatment Period
NOT COMPLETED
|
0
|
2
|
0
|
|
Follow-up Period
STARTED
|
28
|
103
|
66
|
|
Follow-up Period
COMPLETED
|
28
|
3
|
0
|
|
Follow-up Period
NOT COMPLETED
|
0
|
100
|
66
|
Reasons for withdrawal
| Measure |
Group 1
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
1
|
0
|
|
Follow-up Period
Lost to Follow-up
|
0
|
5
|
7
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
2
|
5
|
|
Follow-up Period
Study terminated by sponsor
|
0
|
27
|
23
|
|
Follow-up Period
Received COVID-19 booster outside of trial
|
0
|
66
|
30
|
|
Follow-up Period
Patient is busy at work and withdraws the IC
|
0
|
0
|
1
|
Baseline Characteristics
ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects
Baseline characteristics by cohort
| Measure |
Group 1
n=28 Participants
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=103 Participants
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=66 Participants
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
51 years
STANDARD_DEVIATION 15.88 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 14.39 • n=5 Participants
|
48.7 years
STANDARD_DEVIATION 15.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
196 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=5 Participants
|
103 participants
n=7 Participants
|
66 participants
n=5 Participants
|
197 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3)Population: All subjects who were in the Safety Analysis Set and had at least 1 post-vaccination neutralizing antibody titer result. Subjects with protocol deviations substantially affecting the immunogenicity outcomes were excluded from this analysis set. For the purpose of the primary estimate, this included SARS-CoV-2 infection prior to 2 weeks after last vaccination.
The primary endpoint was SARS-CoV-2 index virus neutralizing antibody titers by pseudovirus assay at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3), for subjects in the Immunogenicity Analysis Set.
Outcome measures
| Measure |
Group 1
n=24 Participants
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=99 Participants
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=65 Participants
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination
|
516.7 titer
Interval 309.0 to 864.0
|
970.9 titer
Interval 804.1 to 1172.3
|
978.9 titer
Interval 781.0 to 1226.8
|
SECONDARY outcome
Timeframe: Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.Population: All subjects who received at least one vaccination with ABNCoV2 at any time during the trial.
Subjects reporting any serious adverse events (SAEs) or adverse events of special interest (AESIs) assessed as related to trial vaccine within 8 days after vaccination
Outcome measures
| Measure |
Group 1
n=28 Participants
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=103 Participants
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=66 Participants
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.Population: All subjects who received at least one vaccination with ABNCoV2 at any time during the trial.
Subjects reporting any Grade ≥ 3 adverse events (AEs) assessed as related to trial vaccine within 8 days after vaccination
Outcome measures
| Measure |
Group 1
n=28 Participants
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=103 Participants
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=66 Participants
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=28 participants at risk
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=103 participants at risk
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=66 participants at risk
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
1.9%
2/103 • Number of events 2 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.97%
1/103 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.97%
1/103 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.97%
1/103 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.97%
1/103 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.97%
1/103 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/28 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/103 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
1.5%
1/66 • Number of events 1 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
Other adverse events
| Measure |
Group 1
n=28 participants at risk
Seronegative adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1 and Day 29
|
Group 2
n=103 participants at risk
Seropositive adult subjects 100ug ABNCoV2 by subcutaneous injection on Day 1
|
Group 3
n=66 participants at risk
Seropositive adult subjects 50ug ABNCoV2 by subcutaneous injection on Day 1
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
17.9%
5/28 • Number of events 6 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
6.8%
7/103 • Number of events 7 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
4.5%
3/66 • Number of events 3 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
General disorders
Pyrexia
|
7.1%
2/28 • Number of events 3 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/103 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
General disorders
Malaise
|
7.1%
2/28 • Number of events 2 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/103 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
2/28 • Number of events 2 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/103 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/103 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
0.00%
0/66 • Overall trial from first vaccination through final follow up visit; i.e., 17 weeks for Group 1 and 2 years for Groups 2 and 3.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution/Investigator agree to submit any proposed publication or presentation to Sponsor for review at least 60 days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation. Sponsor shall have the right to require Institution/Investigator to remove specifically identified Confidential Information and/or to delay the proposed publication or presentation for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
- Publication restrictions are in place
Restriction type: OTHER