Evidence map›Paper›PMID 40976661›Full record

ArticleBMJ open2025

Safety and immunogenicity of rVSVΔG-ZEBOV-GP vaccination when dosed concurrent with mRNA COVID-19 vaccine booster doses in healthy African adults (EbolaCov): protocol for a phase IV, single-centre, single-blinded, randomised controlled trial.

Karishma Gokani, Alice Taylor, Alice Packham, Jean Pierre Musabyimana, Hugor Shema, Ariane Mutabaruka, Siobhan Roche, Yemisi Takwoingi, Claudine Umuhoza, Julien Nyombayire and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06587503 (EbolaCov), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

NCT06587503 phase4unknown statusnot on this map

EbolaCov: A Phase IV, Single-centre, Single-blinded, Randomized Controlled Trial to Assess Safety and Immunogenicity of rVSVΔG-ZEBOV-GP Vaccination When Dosed Concurrent With mRNA COVID-19 Vaccine Booster Doses in Healthy African Adults

TypeinterventionalSponsorUniversity of BirminghamRan2024 to 2025Enrolled72ConditionsEbola Virus Disease, COVID-19ArmsBioNTech - Pfizer COVID-19 vaccine, 1mL saline solution, rVSV∆G-ZEBOV-GP
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Karishma GokaniUniversity of Birmingham, Birmingham, UK k.gokani@bham.ac.uk.ORCID http://orcid.org/0000-0002-4144-3321
Alice TaylorUniversity of Birmingham, Birmingham, UK.
Alice PackhamUniversity of Birmingham, Birmingham, UK.
Jean Pierre MusabyimanaAfrican Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda.
Hugor ShemaAfrican Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda.
Ariane MutabarukaAfrican Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda.
Siobhan RocheUniversity of Birmingham, Birmingham, UK.
Yemisi TakwoingiPublic Health and Epidemiology, University of Birmingham, Birmingham, UK.
Claudine UmuhozaCenter for Family Health Research, Kigali, Rwanda.
Julien NyombayireCenter for Family Health Research, Kigali, Rwanda.
Claude MuvunyiRwanda Biomedical Centre, Kigali, Rwanda.
Christopher GreenUniversity of Birmingham, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEbola virus disease remains a significant public health concern. For protection from Ebola virus, the main target populations are epidemiologically identified and often include healthcare workers and refugees. These target populations are also routinely offered vaccines for other vaccine-preventable diseases. However, concomitant use of rVSVΔG-ZEBOV-GP with other vaccines is not recommended, given the absence of data regarding its reactogenicity and antigen-specific immunogenicity profile when co-administered. The EbolaCov trial aims to inform whether rVSVΔG-ZEBOV-GP can be administered concurrent to a Pfizer-BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and/or loss of humoral immunogenicity to Ebola vaccine antigen. METHODS AND ANALYSIS: This is a single-centre, randomised, single-blinded, vaccine safety and immunogenicity study in healthy adults living in Rwanda. Seventy-two participants will be randomised in a 1:1 ratio to two study groups, the first receiving rVSVΔG-ZEBOV-GP with a placebo, the second group receiving rVSVΔG-ZEBOV-GP concurrently with a Pfizer-BioNTech COVID-19 booster dose. The primary outcome measures are quantitative serum anti-glycoprotein (GP) antibody responses, as measured by ELISA, 28 days after vaccination, and frequency and severity of adverse events in the 7 days following vaccination. Secondary outcome measures include day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-spike protein-specific geometric mean antibody titres. ETHICS AND DISSEMINATION: This trial was approved by the Rwanda National Ethics Committee (reference 442/2024) and the University of Birmingham (reference ERN_2661-Jun2024). All participants were required to provide written informed consent in accordance with good clinical practice. Dissemination of results will be through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503).

Indexed as

COVID-19COVID-19 VaccinesEbola VaccinesHemorrhagic Fever, EbolaImmunization, SecondaryImmunogenicity, VaccineAdultAntibodies, ViralBNT162 VaccineClinical Trials, Phase IV as TopicFemaleHumansMaleRandomized Controlled Trials as TopicRwandaSARS-CoV-2Antibodies, ViralBNT162 VaccineCOVID-19 VaccinesEbola VaccinesClinical ProtocolsDisease OutbreaksImmunityImmunization ProgramsINFECTIOUS DISEASESVaccination

Identifiers

PMID40976661
PMCPMC12458633

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.