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Published on: September 27, 2014
A Recombinant Vesicular Stomatitis Virus Ebola Vaccine
Jason A Regules1, John H Beigel1, Kristopher M Paolino1
1From the Walter Reed Army Institute of Research (J.A.R., K.M.P., A.R.C., J.E.M., R.C.R., J.W.B., P.S.T., S.A.R., H.R.H., M.S., L.L.J., S.A.P., N.L.M., S.J.T.) and Naval Medical Research Center (R.L.G.), Silver Spring, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research (J.H.B., W.J.), and the U.S. Army Medical Research Institute of Infectious Diseases (M.L.W., M.D.J., S.A.K., N.V.D., K.S.S., J.W.H., P.M.S.), Frederick, and the National Institute of Allergy and Infectious Diseases (NIAID) (J.V., Z.H., P.M., H.C.L., R.T.D.) and NIAID Vaccine Research Center (O.T.M., Y.Z., D.A.S., J.E.L., B.S.G., N.J.S.), Bethesda - all in Maryland; the Public Health Agency of Canada, Ottawa (J.B.A.); and BioProtection Systems-NewLink Genetics, Ames, IA (B.K.M., T.P.M., W.J.R., C.J.L.).
This Ebola vaccine candidate showed promising results in Phase 1 trials, eliciting significant antibody responses. Further evaluation of the 20 million PFU dose is recommended for preventing Ebola virus disease.
Area of Science:
- Vaccinology
- Virology
- Infectious Diseases
Background:
- The 2014 Ebola virus disease (EVD) outbreak was the largest in history, causing over 28,000 cases and 11,000 deaths.
- Attenuated, replication-competent viral vector vaccines are a promising strategy for EVD prevention.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a recombinant vesicular stomatitis virus (rVSV)-based Ebola vaccine candidate (rVSV-ZEBOV).
- To determine the optimal dose and assess the effect of a second dose on immune response.
Main Methods:
- Two Phase 1, placebo-controlled, double-blind, dose-escalation trials were conducted with 78 adult participants.
- Participants received one of three doses (3, 20, or 100 million plaque-forming units [PFU]) of the rVSV-ZEBOV vaccine or placebo.
- A subset of participants received a second vaccine dose on day 28; safety and immunogenicity were assessed via ELISA and neutralization assays.
Main Results:
- The most common adverse events included injection-site pain, fatigue, myalgia, and headache. Transient rVSV viremia occurred after the first dose but was reduced after the second.
- All vaccine recipients achieved seroconversion by day 28.
- Higher antibody titers were observed with 20 and 100 million PFU doses compared to the 3 million PFU dose. A second dose significantly boosted antibody titers.
Conclusions:
- The rVSV-ZEBOV vaccine candidate is safe and elicits anti-Ebola antibody responses.
- A dose of 20 million PFU appears suitable for further evaluation for pre-exposure prophylaxis.
- A second dose may enhance and prolong antibody responses, warranting further investigation.
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