Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 220, Issue 1, Pages 57-67Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiz071
Keywords
Ebola vaccine; heterologous 2-dose; Ad26.ZEBOV; MVA-BN-Filo; safety and immunogenicity
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Funding
- Innovative Medicines Initiative 2 Joint Undertaking [115854, 115861, 115850, 115847]
- Janssen Vaccines and Prevention
- European Union
- European Federation of Pharmaceutical Industries and Association
- National Institute of Allergy and Infectious Diseases, National Institutes of Health [HHSN272200800056C]
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Background. 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. Methods. 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. Results. 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 virus glycoprotein antibodies were induced by all regimens and sustained to day 360 after the first dose. Conclusions. Two-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo was well tolerated and highly immunogenic against Ebola virus glycoprotein.
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