Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a (NCT NCT04773665)
NCT ID: NCT04773665
Last Updated: 2024-05-17
Results Overview
The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
114 participants
Primary outcome timeframe
Through 7 days after each study vaccination
Results posted on
2024-05-17
Participant Flow
Participant milestones
| Measure |
Phase 1a, Group G1
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
20
|
27
|
26
|
|
Overall Study
COMPLETED
|
19
|
19
|
19
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a
Baseline characteristics by cohort
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 Participants
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 Participants
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 9.45 • n=7 Participants
|
30.8 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 11.03 • n=4 Participants
|
36.6 years
STANDARD_DEVIATION 9.87 • n=21 Participants
|
33.68 years
STANDARD_DEVIATION 9.77 • n=10 Participants
|
|
Age, Customized
18 to 39
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
79 Participants
n=10 Participants
|
|
Age, Customized
40 to 55
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · First Nations
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
110 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
27 participants
n=4 Participants
|
26 participants
n=21 Participants
|
114 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Through 7 days after each study vaccinationPopulation: Safety Set: subjects who received a study vaccination.
The occurrence of local (near injection site) adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 Participants
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 Participants
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Any local solicited adverse event
|
13 Participants
|
17 Participants
|
11 Participants
|
23 Participants
|
8 Participants
|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Pain
|
11 Participants
|
17 Participants
|
10 Participants
|
20 Participants
|
4 Participants
|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Tenderness
|
10 Participants
|
13 Participants
|
9 Participants
|
19 Participants
|
6 Participants
|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Itchiness
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Erythema/redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Local Solicited Adverse Events After Each Study Vaccination
Induration/swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 7 days after each study vaccinationPopulation: Safety Set: subjects who received a study vaccination.
The occurrence of systemic adverse events actively solicited from the participant during the post-administration follow-up period. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 Participants
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 Participants
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Nausea/vomiting
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Any systemic solicited adverse event
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Fatigue
|
12 Participants
|
12 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Diarrhoea
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Headache
|
9 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Myalgia
|
8 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Rate of Systemic Solicited Adverse Events After Each Study Vaccination
Fever
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 28 days after each study vaccinationPopulation: Safety Set: subjects who received a study vaccination.
Any adverse event reported in addition to those solicited during the clinical study. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with this treatment. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 Participants
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 Participants
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Headache
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Anxiety
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Heavy menstrual bleeding
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Alcohol poisoning
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Haemoglobin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Bone pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Muscle fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Musculoskeletal stiffness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Neck pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Pain in extremity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Menstruation irregular
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Oligomenorrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Oropharyngeal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Any unsolicited AE
|
11 Participants
|
12 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Palpitations
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Eye pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Dyspepsia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Nausea
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Paraesthesia oral
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Chest pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Chills
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Fatigue
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Injection site bruising
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Injection site haemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Injection site pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Pyrexia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Vaccination site pain
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Vaccination site reaction
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
COVID-19
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Oral herpes
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Pharyngitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Rhinitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Urinary tract infection
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Arthropod bite
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Limb injury
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Gamma-glutamyltransferase decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Liver function test increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Lymph node palpable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Arthralgia
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Joint stiffness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Muscular weakness
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Myalgia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Dizziness
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Vaginal haemorrhage
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Cough
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Dyspnoea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Nasal congestion
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Rhinorrhoea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Throat tightness
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Alopecia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Eustachian tube obstruction
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Tinnitus
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Vertigo
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Abdominal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Unsolicited Adverse Events After Each Study Vaccination
Flatulence
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Days 1, 7, 28, 35 and 56Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Outcome measures
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Delta, Day 1
|
5.4 50% neutralization titer
Interval 4.9 to 6.0
|
5.0 50% neutralization titer
Interval 4.5 to 5.6
|
5.0 50% neutralization titer
Interval 4.5 to 5.5
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Delta, Day 56
|
5.7 50% neutralization titer
Interval 3.8 to 8.5
|
49.4 50% neutralization titer
Interval 33.8 to 72.0
|
5.0 50% neutralization titer
Interval 3.2 to 7.7
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Ancestral, Day 1
|
6.0 50% neutralization titer
Interval 5.2 to 7.0
|
5.0 50% neutralization titer
Interval 4.2 to 5.9
|
5.0 50% neutralization titer
Interval 4.3 to 5.9
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Ancestral, Day 7
|
6.7 50% neutralization titer
Interval 4.6 to 9.8
|
5.6 50% neutralization titer
Interval 3.8 to 8.4
|
5.0 50% neutralization titer
Interval 3.4 to 7.3
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Ancestral, Day 28
|
13.3 50% neutralization titer
Interval 7.4 to 23.9
|
18.0 50% neutralization titer
Interval 9.9 to 32.9
|
5.0 50% neutralization titer
Interval 2.7 to 9.1
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Ancestral, Day 35
|
12.6 50% neutralization titer
Interval 6.7 to 23.4
|
99.0 50% neutralization titer
Interval 53.2 to 184.2
|
5.0 50% neutralization titer
Interval 2.6 to 9.5
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Ancestral, Day 56
|
5.4 50% neutralization titer
Interval 3.8 to 7.7
|
329.1 50% neutralization titer
Interval 236.9 to 457.2
|
5.0 50% neutralization titer
Interval 3.4 to 7.3
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Beta, Day 1
|
5.4 50% neutralization titer
Interval 4.9 to 5.9
|
5.0 50% neutralization titer
Interval 4.6 to 5.5
|
5.0 50% neutralization titer
Interval 4.6 to 5.5
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Beta, Day 28
|
8.8 50% neutralization titer
Interval 6.1 to 12.7
|
7.3 50% neutralization titer
Interval 5.0 to 10.6
|
5.2 50% neutralization titer
Interval 3.6 to 7.7
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Beta, Day 35
|
7.8 50% neutralization titer
Interval 4.7 to 12.9
|
16.3 50% neutralization titer
Interval 10.0 to 26.5
|
5.0 50% neutralization titer
Interval 3.0 to 8.3
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Beta, Day 56
|
5.0 50% neutralization titer
Interval 3.5 to 7.2
|
28.0 50% neutralization titer
Interval 20.0 to 39.2
|
5.0 50% neutralization titer
Interval 3.4 to 7.4
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Delta, Day 28
|
10.8 50% neutralization titer
Interval 7.2 to 16.3
|
14.3 50% neutralization titer
Interval 9.5 to 21.6
|
5.0 50% neutralization titer
Interval 3.3 to 7.5
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1a)
Delta, Day 35
|
9.7 50% neutralization titer
Interval 6.0 to 15.6
|
27.6 50% neutralization titer
Interval 17.2 to 44.5
|
5.0 50% neutralization titer
Interval 3.1 to 8.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Days 1, 7, 28, 35, 56 and 112Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Outcome measures
| Measure |
Phase 1a, Group G1
n=21 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 Participants
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 35
|
186.8 ELISA laboratory units per mL
Interval 93.3 to 374.0
|
793.8 ELISA laboratory units per mL
Interval 413.5 to 1523.9
|
25.2 ELISA laboratory units per mL
Interval 12.8 to 49.3
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 112
|
127.0 ELISA laboratory units per mL
Interval 29.4 to 548.4
|
766.3 ELISA laboratory units per mL
Interval 329.3 to 1783.2
|
25.2 ELISA laboratory units per mL
Interval 10.8 to 58.5
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 1
|
28.4 ELISA laboratory units per mL
Interval 24.6 to 32.7
|
25.2 ELISA laboratory units per mL
Interval 21.7 to 29.1
|
25.2 ELISA laboratory units per mL
Interval 21.8 to 29.0
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 7
|
33.4 ELISA laboratory units per mL
Interval 24.0 to 46.5
|
25.2 ELISA laboratory units per mL
Interval 18.0 to 35.3
|
25.2 ELISA laboratory units per mL
Interval 18.1 to 35.0
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 28
|
161.5 ELISA laboratory units per mL
Interval 90.3 to 288.7
|
123.9 ELISA laboratory units per mL
Interval 70.5 to 217.9
|
25.2 ELISA laboratory units per mL
Interval 14.3 to 44.2
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1a)
Day 56
|
96.6 ELISA laboratory units per mL
Interval 65.6 to 142.3
|
4046.6 ELISA laboratory units per mL
Interval 2854.7 to 5736.2
|
25.2 ELISA laboratory units per mL
Interval 16.8 to 37.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Days 1, 7, 14, 28, 56, 84 and 168Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
Virus-neutralizing antibody titers in serum were determined at baseline and post-vaccination using a pseudovirus neutralization assay (PNA). Titers are expressed as the highest serum dilution neutralizing 50% of viral infectivity (PNA50). Neutralization was tested against pseudoviruses expressing the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus as well as Beta and Delta variants.
Outcome measures
| Measure |
Phase 1a, Group G1
n=27 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=26 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 1
|
247.9 50% neutralization titer
Interval 163.7 to 375.4
|
196.3 50% neutralization titer
Interval 128.6 to 299.7
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 1
|
100.9 50% neutralization titer
Interval 66.4 to 153.4
|
62.2 50% neutralization titer
Interval 40.6 to 95.3
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 7
|
353.5 50% neutralization titer
Interval 236.9 to 527.4
|
184.0 50% neutralization titer
Interval 123.4 to 274.6
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 14
|
476.6 50% neutralization titer
Interval 336.8 to 674.4
|
209.9 50% neutralization titer
Interval 147.4 to 299.0
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 28
|
404.3 50% neutralization titer
Interval 286.4 to 570.7
|
154.4 50% neutralization titer
Interval 107.9 to 220.9
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 56
|
474.4 50% neutralization titer
Interval 263.5 to 854.0
|
194.5 50% neutralization titer
Interval 106.3 to 355.9
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 84
|
323.7 50% neutralization titer
Interval 95.6 to 1095.5
|
264.2 50% neutralization titer
Interval 59.4 to 1175.8
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Ancestral, Day 168
|
382.5 50% neutralization titer
Interval 177.0 to 826.5
|
429.8 50% neutralization titer
Interval 167.3 to 1104.2
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 7
|
215.1 50% neutralization titer
Interval 152.6 to 303.4
|
63.8 50% neutralization titer
Interval 44.9 to 90.5
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 28
|
388.0 50% neutralization titer
Interval 263.0 to 572.5
|
63.9 50% neutralization titer
Interval 42.7 to 95.8
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 56
|
267.9 50% neutralization titer
Interval 147.3 to 487.2
|
50.7 50% neutralization titer
Interval 27.4 to 93.6
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 84
|
351.1 50% neutralization titer
Interval 118.6 to 1039.6
|
79.6 50% neutralization titer
Interval 21.1 to 300.6
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Beta, Day 168
|
264.8 50% neutralization titer
Interval 147.2 to 476.2
|
139.6 50% neutralization titer
Interval 68.0 to 286.5
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 1
|
65.0 50% neutralization titer
Interval 44.1 to 95.7
|
57.1 50% neutralization titer
Interval 38.5 to 84.6
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 7
|
102.7 50% neutralization titer
Interval 70.7 to 149.3
|
54.3 50% neutralization titer
Interval 37.4 to 79.0
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 28
|
138.5 50% neutralization titer
Interval 94.2 to 203.6
|
49.8 50% neutralization titer
Interval 33.4 to 74.4
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 56
|
110.9 50% neutralization titer
Interval 65.9 to 186.6
|
39.6 50% neutralization titer
Interval 23.2 to 67.7
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 84
|
221.2 50% neutralization titer
Interval 81.7 to 598.9
|
82.7 50% neutralization titer
Interval 24.4 to 280.3
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Neutralizing Antibody in Serum (Phase 1b)
Delta, Day 168
|
151.4 50% neutralization titer
Interval 59.0 to 388.8
|
201.9 50% neutralization titer
Interval 63.6 to 640.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Days 1, 7,14, 28, 56, 84,168 and 336Population: Full Analysis Set: Includes all subjects from the Intent-to-Treat (ITT) set who received the prescribed study vaccine and underwent immunogenicity assessment at baseline and at least one time point after baseline.
Binding of serum antibody to SARS-CoV-2 spike protein was determined at baseline and post-vaccination by enzyme-linked immunosorbent assay (ELISA). Antibody levels are expressed as ELISA laboratory units (ELU)/mL. Binding antibody was tested against the spike protein of the ancestral (Wuhan) SARS-CoV-2 virus.
Outcome measures
| Measure |
Phase 1a, Group G1
n=27 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=26 Participants
Previously unvaccinated participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
Previously unvaccinated participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
Previously vaccinated participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
Previously vaccinated participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 1
|
5169.1 ELISA laboratory units per mL
Interval 3569.7 to 7485.0
|
3979.4 ELISA laboratory units per mL
Interval 2728.8 to 5803.1
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 7
|
6952.7 ELISA laboratory units per mL
Interval 4915.7 to 9833.7
|
3894.4 ELISA laboratory units per mL
Interval 2753.4 to 5508.2
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 14
|
8716.8 ELISA laboratory units per mL
Interval 6388.1 to 11894.3
|
3771.4 ELISA laboratory units per mL
Interval 2747.5 to 5176.8
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 28
|
8915.0 ELISA laboratory units per mL
Interval 6489.2 to 12247.7
|
3269.2 ELISA laboratory units per mL
Interval 2350.2 to 4547.7
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 56
|
8223.0 ELISA laboratory units per mL
Interval 5247.0 to 12820.8
|
3177.6 ELISA laboratory units per mL
Interval 2013.4 to 5105.0
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 84
|
10090.9 ELISA laboratory units per mL
Interval 3840.3 to 26515.2
|
4718.2 ELISA laboratory units per mL
Interval 1445.2 to 15404.1
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Spike Protein Binding Antibody in Serum (Phase 1b)
Day 168
|
8340.2 ELISA laboratory units per mL
Interval 4014.1 to 17328.5
|
6736.9 ELISA laboratory units per mL
Interval 2751.0 to 16497.5
|
—
|
—
|
—
|
Adverse Events
Phase 1a, Group G1
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase 1a, Group G2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Phase 1a, Group G3
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Phase 1b, Group G4
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Phase 1b, Group G5
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1a, Group G1
n=21 participants at risk
Participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 participants at risk
Participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 participants at risk
Participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 participants at risk
Participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 participants at risk
Participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
4.8%
1/21 • Number of events 1 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
Other adverse events
| Measure |
Phase 1a, Group G1
n=21 participants at risk
Participants received VBI-2902a at a dose of 5 μg of S protein at Day 1 and placebo at Day 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
Placebo: 0.9% sodium chloride
|
Phase 1a, Group G2
n=20 participants at risk
Participants received VBI-2902a at a dose of 5 μg of S protein at Days 1 and 28
VBI-2902a: VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1a, Group G3
n=20 participants at risk
Participants received placebo at Days 1 and 28
Placebo: 0.9% sodium chloride
|
Phase 1b, Group G4
n=27 participants at risk
Participants received VBI-2905a at a dose of 5 μg of S protein at Day 1
VBI-2905a: VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
|
Phase 1b, Group G5
n=26 participants at risk
Participants received placebo at Day 1
Placebo: 0.9% sodium chloride
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.0%
3/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
11.1%
3/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Chills
|
9.5%
2/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.0%
3/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Fatigue
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.0%
3/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
25.0%
5/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
11.5%
3/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Injection site bruising
|
4.8%
1/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Pain
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Pyrexia
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.0%
3/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
General disorders
Vaccination site pain
|
47.6%
10/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
35.0%
7/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
45.0%
9/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
29.6%
8/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
46.2%
12/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Gastrointestinal disorders
Vaccination site swelling
|
9.5%
2/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Infections and infestations
COVID-19
|
23.8%
5/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
25.0%
5/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
74.1%
20/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
61.5%
16/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
25.0%
5/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
30.0%
6/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
11.1%
3/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.4%
4/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
9.5%
2/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
10.0%
2/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
25.0%
5/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
20.0%
4/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.4%
2/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
15.4%
4/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
3/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.4%
2/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.7%
2/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
14.8%
4/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
19.2%
5/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.4%
2/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.7%
1/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.7%
2/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
11.5%
3/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
7.4%
2/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/21 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
0.00%
0/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
5.0%
1/20 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
11.1%
3/27 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
3.8%
1/26 • Adverse events were collected for 1 year (Day 1 to Day 336) or early withdrawal, in all participants, in all groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place