Evidence map›Paper›PMID 37967326›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

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.

Andrew W Lee, Ken Liu, Edouard Lhomme, Julie Blie, John McCullough, Matthew T Onorato, Laurie Connor, Jakub K Simon, Sheri Dubey, Susan VanRheenen and 23 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02876328 (Partnership for Research on Ebola VACcinations), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.9field-weighted citation impact, top 8% of its field
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.

NCT02876328 phase2completednot on this map

Partnership for Research on Ebola VACcinations (PREVAC)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2023Enrolled4,789ConditionsEbola Virus DiseaseArmsAd26.ZEBOV, MVA-BN-Filo, rVSVΔG-ZEBOV-GP, Placebo, rVSV boost
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Algal Lectin Griffithsin Inhibits Ebola Virus Infection.Molecules (Basel, Switzerland) · 2025
    Article
  9. Article
  10. Article
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

33 authors at 10 institutions in 7 countries.

Andrew W LeeMerck & Co., Inc., Rahway, New Jersey, USA.
Ken LiuMerck & Co., Inc., Rahway, New Jersey, USA.
Edouard LhommeInserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, University of Bordeaux, Bordeaux, France.
Julie BliePartnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia.
John McCulloughAdvanced BioMedical Laboratories (ABML), Cinnaminson, New Jersey, USA.
Matthew T OnoratoMerck & Co., Inc., Rahway, New Jersey, USA.
Laurie ConnorMerck & Co., Inc., Rahway, New Jersey, USA.
Jakub K SimonMerck & Co., Inc., Rahway, New Jersey, USA.
Sheri DubeyMerck & Co., Inc., Rahway, New Jersey, USA.
Susan VanRheenenMerck & Co., Inc., Rahway, New Jersey, USA.
Jonathan DeutschMerck & Co., Inc., Rahway, New Jersey, USA.
Abigail OwensMerck & Co., Inc., Rahway, New Jersey, USA.
Amy MorganMerck & Co., Inc., Rahway, New Jersey, USA.
Carolee WelebobMerck & Co., Inc., Rahway, New Jersey, USA.
Donna HyattMerck & Co., Inc., Rahway, New Jersey, USA.
Sunita NairMerck & Co., Inc., Rahway, New Jersey, USA.
Benjamin HamzéPôle Recherche Clinique, Institut National de la Santé et de la Recherche Médicale (Inserm), Paris, France.
Oumar GuindoUniversity Clinical Research Center (UCRC), Bamako, Mali.
Samba O SowCVD-Mali, Bamako, Mali.
Abdoul H BeavoguiCentre National de Formation et de Recherche en Santé Rurale (CNFRSR), Maferinyah, Guinea.
Bailah LeighCollege of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone, Freetown, Sierra Leone.
Mohamed SamaiCollege of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone, Freetown, Sierra Leone.
Pauline AkooDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.
Alimamy Serry-BanguraCollege of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone, Freetown, Sierra Leone.
Suzanne FleckDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.
Fatou SeckaDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.
Brett LoweDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.
Deborah Watson-JonesDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.
Céline RoyInserm, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, University of Bordeaux, Bordeaux, France.
Lisa E HensleyNational Bio and Agro-Defense Facility (NBAF), United States Department of Agriculture (USDA), Manhattan, Kansas, USA.
Mark KiehPartnership for Research on Ebola Vaccines in Liberia (PREVAIL), Monrovia, Liberia.
Beth-Ann G CollerMerck & Co., Inc., Rahway, New Jersey, USA.
PREVAC Study Team
Merck & Co., Inc., Rahway, NJ, USA (United States) · USLondon School of Hygiene & Tropical Medicine · GBUniversity of Sierra Leone · SLUniversité de Bordeaux · FRCentre Pour le Développement des Vaccins-Mali · MLAdvanced Bioscience Laboratories (United States) · USPlanned Parenthood Association of Liberia · LRUnited States Department of Agriculture · USInserm · FRUniversity of Bamako · ML

Funding

ASPR HHS HHSO100201700018C
6 · The paper itself

Abstract

backgroundThe rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older.

methodsThe Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR.

resultsIn total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2.

conclusionsA single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).

Indexed as

Ebola VaccinesEbolavirusHemorrhagic Fever, EbolaAdultAntibodies, ViralChildHumansImmunogenicity, VaccineVaccinationVaccines, AttenuatedVaccines, SyntheticViral Envelope ProteinsAntibodies, ViralEbola VaccinesVaccines, AttenuatedVaccines, SyntheticViral Envelope ProteinsEbolaimmunogenicitypediatricsvaccinevaccine shedding

Identifiers

PMID37967326
PMCPMC11006114
OpenAlexW4388737362

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.