Evidence map›Paper›PMID 31505665›Full record

Trial reportThe Journal of infectious diseases2019

Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults.

Scott A Halperin, Rituparna Das, Matthew T Onorato, Kenneth Liu, Jason Martin, Rebecca J Grant-Klein, Rick Nichols, Beth-Ann Coller, Frans A Helmond, Jakub K Simon and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02503202 (A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT02503202 phase3completednot on this map

A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2017Enrolled1,197ConditionsPrevention of Ebola InfectionArmsV920 Consistency Lot A, V920 Consistency Lot B, V920 Consistency Lot C, V920 High-dose Lot, Placebo to V920
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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 · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Scott A HalperinCanadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and Nova Scotia Health Authority, Halifax, Canada.
Rituparna DasMerck & Co., Inc., Kenilworth, New Jersey.
Matthew T OnoratoMerck & Co., Inc., Kenilworth, New Jersey.
Kenneth LiuMerck & Co., Inc., Kenilworth, New Jersey.
Jason MartinMerck & Co., Inc., Kenilworth, New Jersey.
Rebecca J Grant-KleinMerck & Co., Inc., Kenilworth, New Jersey.
Rick NicholsNewLink Genetics, Inc., BioProtection Systems, Ames, Iowa.
Beth-Ann CollerMerck & Co., Inc., Kenilworth, New Jersey.
Frans A HelmondMerck & Co., Inc., Kenilworth, New Jersey.
Jakub K SimonMerck & Co., Inc., Kenilworth, New Jersey.
V920-012 Study Team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis double-blind study assessed immunogenicity, lot consistency, and safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP).

methodsHealthy adults (N = 1197) were randomized 2:2:2:2:1 to receive 1 of 3 consistency lots of rVSVΔG-ZEBOV-GP (2 × 107 plaque-forming units [pfu]), high-dose 1 × 108 pfu, or placebo. Antibody responses pre-/postvaccination (28 days, 6 months; in a subset [n = 566], months 12, 18, and 24) were measured. post hoc analysis of risk factors associated with arthritis following vaccination was performed.

resultsZEBOV-GP enzyme-linked immunosorbent assay (ELISA) geometric mean titers (GMTs) increased postvaccination in all rVSVΔG-ZEBOV-GP groups by 28 days (>58-fold) and persisted through 24 months. The 3 manufacturing lots demonstrated equivalent immunogenicity at 28 days. Neutralizing antibody GMTs increased by 28 days in all rVSVΔG-ZEBOV-GP groups, peaking at 18 months with no decrease through 24 months. At 28 days, ≥94% of vaccine recipients seroresponded (ZEBOV-GP ELISA, ≥2-fold increase, titer ≥200 EU/mL), with responses persisting at 24 months in ≥91%. Female sex and a history of arthritis were identified as potential risk factors for the development of arthritis postvaccination.

conclusionsImmune responses to rVSVΔG-ZEBOV-GP persisted to 24 months. Immunogenicity and safety results support continued rVSVΔG-ZEBOV-GP development. CLINICAL TRIALS REGISTRATION: NCT02503202.

Indexed as

VaccinationAdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodEbola VaccinesEbolavirusEnzyme-Linked Immunosorbent AssayFemaleFollow-Up StudiesHealthy VolunteersHemorrhagic Fever, EbolaHumansImmunogenicity, VaccineMaleMiddle AgedAntibodies, NeutralizingAntibodies, ViralEbola Vaccinesenvelope glycoprotein, Ebola virusViral Envelope Proteinsclinical trialEbolaimmunogenicityrVSVΔG-ZEBOV-GPvaccine

Identifiers

PMID31505665
PMCPMC6812306

What OpenQuestion holds

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Registered trials

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.