Trial reportThe New England journal of medicine2017
Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02344407 (Partnership for Research on Ebola Vaccines in Liberia), which is not on this map. Cited by 134 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 2 pooled it
18.8field-weighted citation impact, top 1% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
Who cites it
134 citing papers in PubMed, 2 syntheses or guidelines pooled it, 250 citations in OpenAlex.
- Immunogenicity and safety of Ebola virus vaccines in healthy adults: a systematic review and network meta-analysis.Human vaccines & immunotherapeutics · 2021Pooled it
- Use of Ebola Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021Guideline
- Effect of the time of day for vaccination on the immune response to Ebola Virus Disease vaccines: A modeling study from PREVAC randomized trial.PLoS neglected tropical diseases · 2026Trial
- Evaluation of waning of IgG antibody responses after rVSVΔG-ZEBOV-GP and Ad26.ZEBOV, MVA-BN-Filo Ebola virus disease vaccines: a modelling study from the PREVAC randomized trial.Emerging microbes & infections · 2025Trial
- Vector-Induced Humoral Responses After rVSVΔG-ZEBOV-GP Immunization Identify Vaccinated Individuals and Correlate With Ebola Virus Glycoprotein Antibodies.The Journal of infectious diseases · 2025Trial
- Safety and immunogenicity of GamEvac-Combi, a heterologous rVSV- and rAd5-vectored Ebola vaccine: a randomized controlled multicenter clinical trial in the Republic of Guinea and Russia.Frontiers in immunology · 2025Trial
- Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- The impact of the 2014 Ebola epidemic on HIV disease burden and outcomes in Liberia West Africa.PloS one · 2021Trial
- Trial
- Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.Emerging infectious diseases · 2020Trial
- Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults.The Journal of infectious diseases · 2019Trial
- Safety and Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Uganda and Tanzania.The Journal of infectious diseases · 2019Trial
- PREVAIL I Cluster Vaccination Study With rVSVΔG-ZEBOV-GP as Part of a Public Health Response in Liberia.The Journal of infectious diseases · 2019Trial
- The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak.The Journal of infectious diseases · 2018Trial
- Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola.The Journal of infectious diseases · 2018Trial
- Neurological Manifestations in Adult Survivors of Ebola Virus Disease.JAMA neurology · 2026Article
- Confirming ERVEBO Vaccination to Support Ebola Virus Surveillance.Emerging infectious diseases · 2026Article
- Comparison of Four Assays That Measure Antibodies to Ebola Virus Glycoprotein.bioRxiv : the preprint server for biology · 2026Article
- SARS-CoV-2 spike protein expression drives post-acute coagulopathy.Journal of virology · 2026Article
- Article
74 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors at 8 institutions in 3 countries.
Stephen B KennedyFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Fatorma BolayFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Mark KiehFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Greg GranditsFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Moses BadioFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Ripley BallouFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Risa EckesFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Mark FeinbergFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Dean FollmannFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Birgit GrundFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Swati GuptaFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Lisa HensleyFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Elizabeth HiggsFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Krisztina JanoskoFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Melvin JohnsonFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Francis KatehFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
James LogueFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Jonathan MarchandFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Thomas MonathFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Martha NasonFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Tolbert NyenswahFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
François RomanFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Eric StavaleFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
Julian WolfsonFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
James D NeatonFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
H Clifford LaneFrom the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.); the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.); GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland; Merck, Kenilworth, NJ (M.F., S.G.); Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.); International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.); and GlaxoSmithKline, Rixensart, Belgium (F.R.).
PREVAIL I Study Group
University of Liberia · LRNational Institutes of Health · USBattelle · USUniversity of Minnesota · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USGlaxoSmithKline (Belgium) · BEGlaxoSmithKline (United States) · USInternational AIDS Vaccine Initiative · US
Funding
Regulatory Support Services ZIDAI009001 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI TIERNEY, JOHN · 2009 to 2025
$256.2MPathogenesis, Treatment and Prevention of Emerging Infectious DiseasesZIAAI000936 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LANE, CLIFFORD · 2009 to 2025
$6.4MIntramural NIH HHS ZIA AI000936Intramural NIH HHS ZID AI009001
Abstract
backgroundThe safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia.
methodsWe initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated.
resultsA total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons).
conclusionsA randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407 .).
Indexed as
AdenoviridaeAdultAnimalsDisease OutbreaksDouble-Blind MethodEbola VaccinesEbolavirusFemaleFeverHeadacheHemorrhagic Fever, EbolaHIV SeropositivityHumansInjections, IntramuscularLiberiaMaleEbola VaccinesRNA, Viral
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Registered trials
NCT02344407ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.