Trial Outcomes & Findings for Safety and Tolerability of COVID-19 Vaccine (ABNCoV2) (NCT NCT04839146)
NCT ID: NCT04839146
Last Updated: 2026-02-17
Results Overview
Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
up to 28 weeks
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
In Group 1A (n=3), subjects will receive the non-adjuvanted vaccine 6 μg ABNCoV2 formulation intramuscularly.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
In Group 1B (n=3), subjects will receive the MF59-adjuvanted vaccine 6 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
In Group 2A (n=3), subjects will receive the non-adjuvanted vaccine 12 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
In Group 2B (n=3), subjects will receive the MF59-adjuvanted vaccine 12 μg ABNCoV2 formulation intramuscularly.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
In Group 3A (n=3), subjects will receive the non-adjuvanted vaccine 25 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
In Group 3B (n=3), subjects will receive the MF59-adjuvanted vaccine 25 μg ABNCoV2 formulation intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
6
|
9
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
6
|
6
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 Participants
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=3 Participants
|
27 years
n=3 Participants
|
25 years
n=3 Participants
|
37 years
n=3 Participants
|
27 years
n=3 Participants
|
48 years
n=3 Participants
|
25.5 years
n=6 Participants
|
20.5 years
n=6 Participants
|
24 years
n=9 Participants
|
24 years
n=6 Participants
|
26 years
n=45 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
26 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
19 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Bodyweight (kg)
|
79 kg
n=3 Participants
|
66 kg
n=3 Participants
|
78 kg
n=3 Participants
|
88 kg
n=3 Participants
|
70.1 kg
n=3 Participants
|
81 kg
n=3 Participants
|
75 kg
n=6 Participants
|
77.5 kg
n=6 Participants
|
76.6 kg
n=9 Participants
|
69.5 kg
n=6 Participants
|
76 kg
n=45 Participants
|
|
BMI (kg/m^2)
|
23 kg/m^2
n=3 Participants
|
22.4 kg/m^2
n=3 Participants
|
26.0 kg/m^2
n=3 Participants
|
24.9 kg/m^2
n=3 Participants
|
23.6 kg/m^2
n=3 Participants
|
26.4 kg/m^2
n=3 Participants
|
25.0 kg/m^2
n=6 Participants
|
23.7 kg/m^2
n=6 Participants
|
23.3 kg/m^2
n=9 Participants
|
24.5 kg/m^2
n=6 Participants
|
24.2 kg/m^2
n=45 Participants
|
PRIMARY outcome
Timeframe: up to 28 weeksPrimary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE)
Outcome measures
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 Participants
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of at Least Possibly Related Grade 3 Adverse Events (AE) and Serious Adverse Events (SAE)
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: 14 days following first vaccination.Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies 14 days following first vaccination
Outcome measures
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 Participants
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Concentration of ABNCoV2-specific Antibodies 14 Days Following First Vaccination
|
2.2 ug/mL
Interval 0.4 to 5.8
|
4.9 ug/mL
Interval 3.6 to 30.1
|
7.1 ug/mL
Interval 2.3 to 7.1
|
9.4 ug/mL
Interval 8.7 to 95.5
|
2.3 ug/mL
Interval 1.6 to 34.4
|
0.4 ug/mL
Interval 0.4 to 5.7
|
4.2 ug/mL
Interval 2.4 to 22.0
|
4.9 ug/mL
Interval 0.1 to 16.8
|
5.0 ug/mL
Interval 1.7 to 20.4
|
7.3 ug/mL
Interval 5.5 to 35.1
|
SECONDARY outcome
Timeframe: one week after each vaccination with of ABNCoV2.Population: Proportion of participants with related adverse event
Secondary study endpoint: Number and severity of at least possibly related solicited AEs
Outcome measures
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 Participants
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 Participants
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 Participants
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least Possibly Related Solicited AEs
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 28 weeksABNCoV2-specific antibody concentrations will be measured by ELISA during immunisation and follow-up.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 28 weeksInhibitory titre in invasion inhibition assay at baseline and during immunization and follow up. Inhibitory titres will be measured in an in vitro SARS-CoV-2 invasion inhibition assay.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 28 weeksCellular responses will be analysed by cytometry and enzyme-linked absorbent spot (ELISpot) assay.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: one month prior first ABNCoV2 immunizationThe PSQI will be used to investigate if sleep quality is associated with immune responses to the vaccine.
Outcome measures
Outcome data not reported
Adverse Events
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 participants at risk
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial basal cell carcinoma
|
0.00%
0/3 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/6 • 7 months
|
0.00%
0/6 • 7 months
|
0.00%
0/9 • 7 months
|
0.00%
0/6 • 7 months
|
|
Musculoskeletal and connective tissue disorders
Ligament rupture
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/6 • 7 months
|
0.00%
0/6 • 7 months
|
0.00%
0/9 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
Other adverse events
| Measure |
Group 1A: 6 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 1B: 6 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 1 (n=6), subjects will receive 6 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 1A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 1B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2A: 12 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 2B: 12 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 2 (n=6), subjects will receive 12 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 2A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 2B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3A: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=3 participants at risk
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 3B: 25 Microgram ABNCoV2 With MF59 Adjuvant
n=3 participants at risk
In Group 3 (n=6), subjects will receive 25 μg ABNCoV2 intramuscularly, half of whom (n=3; Group 3A) will receive the non-adjuvanted vaccine formulation and the other half (n=3; Group 3B) will receive the MF59-adjuvanted vaccine formulation. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 4: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
In Group 4 (n=6), subjects will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 5: 70 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
In Group 5 (n=6), subjects will receive 70 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 6: 25 Microgram ABNCoV2 Without MF59 Adjuvant
n=9 participants at risk
The subjects in Group 6 (n=9) will receive 25 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
Group 7: 50 Microgram ABNCoV2 Without MF59 Adjuvant
n=6 participants at risk
The subjects in Group 7 (n=6) will receive 50 μg non-adjuvanted ABNCoV2 intramuscularly. All subjects will receive a second vaccination with the same dose and formulation 4 weeks following the first vaccination.
ABNCoV2 Vaccine: SARS-CoV-2 vaccine
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Tenderness
|
0.00%
0/3 • 7 months
|
100.0%
3/3 • Number of events 4 • 7 months
|
100.0%
3/3 • Number of events 3 • 7 months
|
66.7%
2/3 • Number of events 3 • 7 months
|
33.3%
1/3 • Number of events 2 • 7 months
|
100.0%
3/3 • Number of events 6 • 7 months
|
83.3%
5/6 • Number of events 8 • 7 months
|
50.0%
3/6 • Number of events 5 • 7 months
|
88.9%
8/9 • Number of events 11 • 7 months
|
50.0%
3/6 • Number of events 4 • 7 months
|
|
Skin and subcutaneous tissue disorders
Pain
|
66.7%
2/3 • Number of events 2 • 7 months
|
100.0%
3/3 • Number of events 5 • 7 months
|
100.0%
3/3 • Number of events 7 • 7 months
|
100.0%
3/3 • Number of events 6 • 7 months
|
100.0%
3/3 • Number of events 7 • 7 months
|
100.0%
3/3 • Number of events 9 • 7 months
|
83.3%
5/6 • Number of events 21 • 7 months
|
100.0%
6/6 • Number of events 15 • 7 months
|
100.0%
9/9 • Number of events 21 • 7 months
|
100.0%
6/6 • Number of events 14 • 7 months
|
|
Skin and subcutaneous tissue disorders
Induration
|
33.3%
1/3 • Number of events 1 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
0.00%
0/3 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
33.3%
2/6 • Number of events 3 • 7 months
|
33.3%
2/6 • Number of events 2 • 7 months
|
44.4%
4/9 • Number of events 4 • 7 months
|
50.0%
3/6 • Number of events 3 • 7 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
33.3%
2/6 • Number of events 3 • 7 months
|
50.0%
3/6 • Number of events 3 • 7 months
|
22.2%
2/9 • Number of events 3 • 7 months
|
50.0%
3/6 • Number of events 3 • 7 months
|
|
General disorders
Chills
|
0.00%
0/3 • 7 months
|
33.3%
1/3 • Number of events 2 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
0.00%
0/3 • 7 months
|
50.0%
3/6 • Number of events 6 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
11.1%
1/9 • Number of events 1 • 7 months
|
33.3%
2/6 • Number of events 3 • 7 months
|
|
General disorders
Drowsiness
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
33.3%
1/3 • Number of events 1 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
33.3%
2/6 • Number of events 2 • 7 months
|
22.2%
2/9 • Number of events 2 • 7 months
|
66.7%
4/6 • Number of events 4 • 7 months
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 7 months
|
66.7%
2/3 • Number of events 4 • 7 months
|
66.7%
2/3 • Number of events 3 • 7 months
|
100.0%
3/3 • Number of events 4 • 7 months
|
0.00%
0/3 • 7 months
|
66.7%
2/3 • Number of events 7 • 7 months
|
66.7%
4/6 • Number of events 6 • 7 months
|
50.0%
3/6 • Number of events 6 • 7 months
|
66.7%
6/9 • Number of events 9 • 7 months
|
66.7%
4/6 • Number of events 5 • 7 months
|
|
General disorders
Fever
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
0.00%
0/3 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
33.3%
2/6 • Number of events 2 • 7 months
|
0.00%
0/9 • 7 months
|
16.7%
1/6 • Number of events 1 • 7 months
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 1 • 7 months
|
100.0%
3/3 • Number of events 6 • 7 months
|
66.7%
2/3 • Number of events 2 • 7 months
|
66.7%
2/3 • Number of events 3 • 7 months
|
100.0%
3/3 • Number of events 3 • 7 months
|
66.7%
2/3 • Number of events 5 • 7 months
|
66.7%
4/6 • Number of events 7 • 7 months
|
33.3%
2/6 • Number of events 7 • 7 months
|
66.7%
6/9 • Number of events 9 • 7 months
|
50.0%
3/6 • Number of events 4 • 7 months
|
Additional Information
Benjamin Mordmüller (Principal investigator)
Radboudumc
Phone: +31 (0)24 3619499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place