Trial Outcomes & Findings for Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine) (NCT NCT02788227)
NCT ID: NCT02788227
Last Updated: 2026-06-17
Results Overview
The geometric mean antibody titres (GMT) was measured by Filovirus Animal Nonclinical Group ELISA at month 36 months for the randomized study cohort.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
248 participants
Primary outcome timeframe
Month 36
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Primary Immunization
Adults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
|
Post Month 18: Boosted Group
Participant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
|
Post Month 18: Non-boosted Group
Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.
|
|---|---|---|---|
|
Primary Immunization
STARTED
|
248
|
0
|
0
|
|
Primary Immunization
Received Primary Immunization
|
248
|
0
|
0
|
|
Primary Immunization
At Least One Visit Through Month 18
|
208
|
0
|
0
|
|
Primary Immunization
COMPLETED
|
208
|
0
|
0
|
|
Primary Immunization
NOT COMPLETED
|
40
|
0
|
0
|
|
Randomization Period
STARTED
|
0
|
57
|
57
|
|
Randomization Period
COMPLETED
|
0
|
45
|
47
|
|
Randomization Period
NOT COMPLETED
|
0
|
12
|
10
|
Reasons for withdrawal
| Measure |
Primary Immunization
Adults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
|
Post Month 18: Boosted Group
Participant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
|
Post Month 18: Non-boosted Group
Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.
|
|---|---|---|---|
|
Primary Immunization
Withdrawal by Subject
|
4
|
0
|
0
|
|
Primary Immunization
Lost to Follow-up
|
36
|
0
|
0
|
|
Randomization Period
2020 Pandemic travel restrictions
|
0
|
12
|
10
|
Baseline Characteristics
Immunogenicity of Recombinant Vesicular Stomatitis Vaccine for Ebola-Zaire (rVSV∆G-ZEBOV-GP Vaccine)
Baseline characteristics by cohort
| Measure |
Primary Immunization
n=248 Participants
Adults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
245 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
240 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
208 participants
n=9 Participants
|
|
Region of Enrollment
Canada
|
40 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Month 36Population: Modified Intent to treat population. Per protocol document, analysis applies to participants randomized post month 18 from primary immunization.
The geometric mean antibody titres (GMT) was measured by Filovirus Animal Nonclinical Group ELISA at month 36 months for the randomized study cohort.
Outcome measures
| Measure |
Post Month 18: Boosted Group
n=45 Participants
Participant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
|
Post Month 18: Non-boosted Group
n=47 Participants
Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.
|
|---|---|---|
|
Geometric Mean Antibody Titres
|
10146 EU/mL
Interval 7960.0 to 12933.0
|
1240 EU/mL
Interval 984.0 to 1563.0
|
Adverse Events
Primary Immunization
Serious events: 11 serious events
Other events: 89 other events
Deaths: 0 deaths
Post Month 18: Boosted Group
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Post Month 18: Non-boosted Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Immunization
n=248 participants at risk
Adults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
|
Post Month 18: Boosted Group
n=57 participants at risk
Participant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
|
Post Month 18: Non-boosted Group
n=57 participants at risk
Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.
|
|---|---|---|---|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Cardiac disorders
Viral myocarditis
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Endocrine disorders
Hyperparathyroidism
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Cardiac disorders
Arrhythmia
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Cardiac disorders
Coronary artery disease
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Infections and infestations
Encephalitis
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Infections and infestations
Neuroborreliosis
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Infections and infestations
Propionibacterium infection
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.40%
1/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.81%
2/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/248 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
Other adverse events
| Measure |
Primary Immunization
n=248 participants at risk
Adults deemed to be at current or future occupational risk (laboratory, clinical, or field) for exposure to Ebola virus received a single dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle at the time of enrollment.
|
Post Month 18: Boosted Group
n=57 participants at risk
Participant were randomized at 18 months post primary immunization to receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) 1ml intramuscular injection in the deltoid muscle.
|
Post Month 18: Non-boosted Group
n=57 participants at risk
Participant were randomized at 18 months post primary immunization to not receive a booster dose of rVSV∆G-ZEBOV-GP vaccine (V920) vaccine.
|
|---|---|---|---|
|
Gastrointestinal disorders
Mouth ulceration
|
5.2%
13/248 • All participants were monitored up to month 36 from primary immunization
|
5.3%
3/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Blood and lymphatic system disorders
Eosinophilic pneumonia chronic
|
0.00%
0/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
8.5%
21/248 • All participants were monitored up to month 36 from primary immunization
|
10.5%
6/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
General disorders
Fatigue
|
35.9%
89/248 • All participants were monitored up to month 36 from primary immunization
|
61.4%
35/57 • All participants were monitored up to month 36 from primary immunization
|
5.3%
3/57 • All participants were monitored up to month 36 from primary immunization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
40/248 • All participants were monitored up to month 36 from primary immunization
|
17.5%
10/57 • All participants were monitored up to month 36 from primary immunization
|
7.0%
4/57 • All participants were monitored up to month 36 from primary immunization
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
19/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
35.9%
89/248 • All participants were monitored up to month 36 from primary immunization
|
52.6%
30/57 • All participants were monitored up to month 36 from primary immunization
|
1.8%
1/57 • All participants were monitored up to month 36 from primary immunization
|
|
Nervous system disorders
Headache
|
33.1%
82/248 • All participants were monitored up to month 36 from primary immunization
|
38.6%
22/57 • All participants were monitored up to month 36 from primary immunization
|
8.8%
5/57 • All participants were monitored up to month 36 from primary immunization
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
2.8%
7/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.3%
28/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
7/248 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
0.00%
0/57 • All participants were monitored up to month 36 from primary immunization
|
Additional Information
Dr. Susan Moir
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-402-4559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place