期刊
JOURNAL OF INFECTIOUS DISEASES
卷 220, 期 1, 页码 46-56出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jiz070
关键词
Ebola vaccine; heterologous 2-dose; Ad26.ZEBOV; MVA-BN-Filo; safety and immunogenicity
资金
- Innovative Medicines Initiative 2 Joint Undertaking [115854, 115861, 115850, 115847]
- Janssen Vaccines and Prevention
- European Union's Horizon 2020 Research and Innovation Programme
- European Federation of Pharmaceutical Industries and Association
- National Institute of Allergy and Infectious Diseases, National Institutes of Health [HHSN272200800056C]
- MRC [MR/R010161/1, G0901756, MC_UU_00027/1] Funding Source: UKRI
Background. Ebola vaccine development was accelerated in response to the 2014 Ebola virus infection outbreak. This phase 1 study (VAC52150EBL1004) assessed safety, tolerability, and immunogenicity of heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimens in the Lake Victoria Basin of Tanzania and Uganda in mid-level altitude, malaria-endemic settings. Methods. Healthy volunteers aged 18-50 years from Tanzania (n = 25) and Uganda (n = 47) were randomized to receive placebo or active vaccination with Ad26.ZEBOV or MVA-BN-Filo (first vaccination), followed by MVA-BN-Filo or Ad26.ZEBOV (second vaccination) dose 2, respectively, with intervals of 28 or 56 days. Results. Seventy-two adults were randomized to receive vaccine (n = 60) or placebo (n = 12). No vaccine-related serious adverse events were reported. The most frequent solicited local and systemic adverse events were injection site pain (frequency, 70%, 66%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively) and headache (57%, 56%, and 46%, respectively). Adverse event patterns were similar among regimens. Twenty-one days after dose 2, 100% of volunteers demonstrated binding antibody responses against Ebola virus glycoprotein, and 87%-100% demonstrated neutralizing antibody responses. Ad26.ZEBOV dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination. Conclusions. Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against Ebola virus is well tolerated and immunogenic in healthy volunteers.
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