Safety and Immunogenicity of a 2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical Trial in Nairobi, Kenya

The Journal of Infectious Diseases
Gaudensia MutuaMacaya Douoguih

Abstract

During the 2014 West African Ebola outbreak, Ebola vaccine development was accelerated. The phase 1 VAC52150EBL1003 study was performed to investigate 2-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo in an African population located in a high-altitude setting in Nairobi, Kenya. Healthy adult volunteers were randomized to receive one of four 2-dose vaccination schedules. The first vaccination was administered at baseline (Ad26.ZEBOV or MVA-BN-Filo), followed by the second vaccination with the alternate vaccine after either 28 or 56 days. Each schedule had a placebo comparator group. The primary objective was to assess the safety and tolerability of these regimens. Seventy-two volunteers were randomized into 4 groups of 18 (15 received vaccine, and 3 received placebo). The most frequent solicited systemic adverse event was headache (frequency, 50%, 61%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). The most frequent solicited local AE was injection site pain (frequency, 78%, 63%, and 33% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). No differences in adverse events were observed among the different vaccine regimens. High levels of binding and neutralizing anti-Ebola v...Continue Reading

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Citations

Nov 30, 2019·Expert Review of Vaccines·Keesha M MatzHeinz Feldmann
Dec 11, 2019·The Journal of Infectious Diseases·Helen R WagstaffeMartin R Goodier
Sep 14, 2019·Science Advances·Alexander T BakerAlan L Parker
Oct 12, 2019·The Journal of Infectious Diseases·Daniel G Bausch, Peter Piot
Sep 8, 2020·Paediatrics and International Child Health·Devika DixitMichael T Hawkes
Oct 3, 2020·Equine Veterinary Journal·Javier Castillo-Olivares
Oct 8, 2019·Human Vaccines & Immunotherapeutics·John J Suschak, Connie S Schmaljohn
Apr 22, 2020·The Journal of Clinical Investigation·Helen R WagstaffeMartin R Goodier
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Oct 21, 2020·Vaccine·Ariane VolkmannUNKNOWN Brighton Collaboration Viral Vector Vaccines Safety Working Group V3SWG
Jul 17, 2021·Human Vaccines & Immunotherapeutics·Alhassane DialloFlorence Galtier
Aug 6, 2021·Journal of Thrombosis and Haemostasis : JTH·Maha OthmanAlan L Parker

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Methods Mentioned

BETA
Enzyme-Linked Immunosorbent Assay
Antibody
Assay

Clinical Trials Mentioned

NCT02376426

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