Phase 3
Completed N=1,197
Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
Prevention of Ebola Infection
Source: ClinicalTrials.gov NCT02503202 ↗
Enrolled (actual)
1,197
Serious AEs
4.0%
Results posted
Oct 2018
Primary outcomePrimary: Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody — 1183.9; 1266.0; 1346.0; 1291.9 EU/mL — p=<0.001
◆ Published Evidence
Established
79citations · ~9 / year
Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults.
Summary
The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
Linked Publications (4)
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Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults.
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Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults.
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Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic.
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Effects of Gamma Irradiation of Human Serum Samples from rVSVΔG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody |
1183.9; 1266.0; 1346.0; 1291.9; NA | <0.001 sig |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events |
2.6; 1.5; 2.7; 1.2; 0.0 | 0.368 |
| PRIMARY Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card |
14.7; 10.6; 14.8; 7.3; 1.5; 66.8 | 0.160 |
| PRIMARY Percentage of Participants With Elevated Maximum Temperature |
21.4; 16.7; 22.4; 32.2; 0.8 | 0.176 |
| PRIMARY Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card |
5.7; 5.7; 6.5; 7.7; 1.5; 4.5 | 0.983 |
| PRIMARY Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card |
3.0; 4.6; 3.8; 3.8; 1.5 | 0.353 |
| PRIMARY Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card |
1.9; 1.1; 1.5; 1.5; 0.0 | 0.483 |
Eligibility Criteria
Inclusion Criteria
- Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.
Exclusion Criteria
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
- Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
- Has been exposed to Ebola virus at any time prior to study entry.
- Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
- Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
- Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.
- Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.
- Has received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/day prednisone equivalent) within 14 days prior to study entry.
- Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
- Has known or suspected impairment of immunological function (e.g., HIV positive).
- Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
- Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
- Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
- Has a history of malignancy <=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Data sourced from ClinicalTrials.gov (NCT02503202) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.