{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T22:59:19Z","timestamp":1791932359739,"version":"4.3.4"},"reference-count":18,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,21]],"date-time":"2025-09-21T00:00:00Z","timestamp":1758412800000},"content-version":"unspecified","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Merck Investigator Initiated Studies Program","award":["102051"],"award-info":[{"award-number":["102051"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,2]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"\n Introduction<\/jats:title>\n Ebola 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 rVSV\u0394G-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 rVSV\u0394G-ZEBOV-GP can be administered concurrent to a Pfizer\u2013BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and\/or loss of humoral immunogenicity to Ebola vaccine antigen.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n 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 rVSV\u0394G-ZEBOV-GP with a placebo, the second group receiving rVSV\u0394G-ZEBOV-GP concurrently with a Pfizer\u2013BioNTech 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\u2009days 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.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503<\/jats:ext-link>)<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-102898","type":"journal-article","created":{"date-parts":[[2025,9,22]],"date-time":"2025-09-22T02:32:08Z","timestamp":1758508328000},"page":"e102898","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and immunogenicity of rVSV\u0394G-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"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06587503","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06587503","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4144-3321","authenticated-orcid":false,"given":"Karishma","family":"Gokani","sequence":"first","affiliation":[{"name":"University of Birmingham, Birmingham, UK"},{"name":"Department of Infectious Diseases and Tropical Medicine, NIHR\/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice E","family":"Taylor","sequence":"additional","affiliation":[{"name":"University of Birmingham, Birmingham, UK"},{"name":"Department of Infectious Diseases and Tropical Medicine, NIHR\/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Packham","sequence":"additional","affiliation":[{"name":"University of Birmingham, Birmingham, UK"},{"name":"Department of Infectious Diseases and Tropical Medicine, NIHR\/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean Pierre","family":"Musabyimana","sequence":"additional","affiliation":[{"name":"African Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda"},{"name":"Rwanda Biomedical Center, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugor","family":"Shema","sequence":"additional","affiliation":[{"name":"African Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariane","family":"Mutabaruka","sequence":"additional","affiliation":[{"name":"African Centre for Excellence in Sustainable Cooling and Cold-chain, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siobhan","family":"Roche","sequence":"additional","affiliation":[{"name":"University of Birmingham, Birmingham, UK"},{"name":"Department of Infectious Diseases and Tropical Medicine, NIHR\/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yemisi","family":"Takwoingi","sequence":"additional","affiliation":[{"name":"Public Health and Epidemiology, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudine","family":"Umuhoza","sequence":"additional","affiliation":[{"name":"Center for Family Health Research, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Nyombayire","sequence":"additional","affiliation":[{"name":"Center for Family Health Research, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude","family":"Muvunyi","sequence":"additional","affiliation":[{"name":"Rwanda Biomedical Centre, Kigali, Rwanda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher A","family":"Green","sequence":"additional","affiliation":[{"name":"University of Birmingham, Birmingham, UK"},{"name":"Department of Infectious Diseases and Tropical Medicine, NIHR\/Wellcome Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,9,21]]},"reference":[{"key":"2025100512103943000_15.9.e102898.1","doi-asserted-by":"crossref","DOI":"10.1186\/s12992-016-0194-4","article-title":"Understanding Ebola: the 2014 epidemic","volume":"12","author":"Kaner","year":"2016","journal-title":"Global Health"},{"key":"2025100512103943000_15.9.e102898.2","unstructured":"World Health Organization . Mpox: Multi-country external situation report no. 47. 2025."},{"key":"2025100512103943000_15.9.e102898.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)32621-6"},{"key":"2025100512103943000_15.9.e102898.4","doi-asserted-by":"crossref","first-page":"4877","DOI":"10.1016\/j.vaccine.2020.04.066","article-title":"Humoral and cellular immune response induced by rVSV\u0394G-ZEBOV-GP vaccine among frontline workers during the 2013\u20132016 West Africa Ebola outbreak in Guinea","volume":"38","author":"Boum","year":"2020","journal-title":"Vaccine (Auckl)"},{"key":"2025100512103943000_15.9.e102898.5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1614067"},{"key":"2025100512103943000_15.9.e102898.6","doi-asserted-by":"crossref","first-page":"S6","DOI":"10.1093\/infdis\/jiy020","article-title":"The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV\u2206G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak","volume":"217","author":"Samai","year":"2018","journal-title":"J Infect Dis"},{"key":"2025100512103943000_15.9.e102898.7","unstructured":"Summary of Product Characteristics - Ervebo European Medicines Agency, Available: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/ervebo-epar-product-information_en.pdf"},{"key":"2025100512103943000_15.9.e102898.8","unstructured":"World Health Organization . WHO Director-General\u2019s opening remarks at the media briefing on COVID-19. 2020."},{"key":"2025100512103943000_15.9.e102898.9","unstructured":"World Health Organization . Statement on the update of WHO\u2019s working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest. 2023."},{"key":"2025100512103943000_15.9.e102898.10","unstructured":"World Health Organization . Coronavirus disease (COVID-19) pandemic; Numbers at a glance. 2023."},{"key":"2025100512103943000_15.9.e102898.11","unstructured":"Data OWi . COVID-19, vaccinations (broken down by manufacturer. 2024."},{"key":"2025100512103943000_15.9.e102898.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2034577"},{"key":"2025100512103943000_15.9.e102898.13","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02329-1"},{"key":"2025100512103943000_15.9.e102898.14","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(21)01694-9"},{"key":"2025100512103943000_15.9.e102898.15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02718-5"},{"key":"2025100512103943000_15.9.e102898.16","doi-asserted-by":"crossref","first-page":"2258","DOI":"10.1016\/S0140-6736(21)02717-3","article-title":"Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial","volume":"398","author":"Munro","year":"2021","journal-title":"Lancet"},{"key":"2025100512103943000_15.9.e102898.17","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"2025100512103943000_15.9.e102898.18","doi-asserted-by":"publisher","DOI":"10.1002\/sim.1783"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-102898","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,5]],"date-time":"2025-10-05T19:11:45Z","timestamp":1759691505000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-102898"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":18,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2025,9,21]]},"published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1136\/bmjopen-2025-102898"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-102898","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9]]}}}