After the resurgence of Ebola virus disease in Guinea, 5 years after it became the epicentre of the 2014–16 epidemic in west Africa that claimed more than 11 000 lives, and following successive outbreaks in the Democratic Republic of the Congo, the need for safe and effective vaccines to curb disease transmission remains as urgent as ever. In May, 2020, the Janssen Vaccines & Prevention heterologous primary and booster Ebola vaccine regimen, comprising the adenovirus type 26 vector-based vaccine expressing Zaire Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus (MVA-BN-Filo), administered 8 weeks apart, was granted marketing authorisation by the European Commission for the prevention of Ebola virus disease in adults and children aged 1 years or older. 1 Johnson & JohnsonJohnson & Johnson announces European Commission approval for Janssen's preventive Ebola vaccine. https://www.jnj.com/johnson-johnson-announces-european-commission-approval-for-janssens-preventive-ebola-vaccineDate: 2020 Date accessed: March 17, 2021 Google Scholar Clinical development of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen included several phase 1 clinical trials done simultaneously at various sites: in Uganda, which is endemic for Ebola virus disease and at risk of an outbreak, with reported cases of Ebola virus disease; in Tanzania and Kenya, which are also at risk of an outbreak, but have no previously reported cases of Ebola virus disease; and in the UK and the USA, which are only at risk of imported cases of Ebola virus disease. 2 Pigott DM Golding N Mylne A et al. Mapping the zoonotic niche of Ebola virus disease in Africa. Elife. 2014; 3e04395 Crossref PubMed Scopus (247) Google Scholar These trials allowed the collection of safety, tolerability, and immunogenicity data 3 Milligan ID Gibani MM Sewell R et al. Safety and immunogenicity of novel adenovirus type 26- and modified vaccinia ankara-vectored Ebola vaccines: a randomised clinical trial. JAMA. 2016; 315: 1610-1623 Crossref PubMed Scopus (187) Google Scholar , 4 Goldstein N Bockstal V Bart S et al. Safety and immunogenicity of heterologous and homologous two dose regimens of Ad26- and MVA-vectored Ebola vaccines: a randomised, controlled phase 1 study. J Infect Dis. 2020; (published online Sept 16.)https://doi.org/10.1093/infdis/jiaa586 Crossref Google Scholar , 5 Mutua G Anzala O Luhn K et al. 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. J Infect Dis. 2019; 220: 57-67 Crossref PubMed Scopus (42) Google Scholar , 6 Anywaine Z Whitworth H Kaleebu P et al. Safety and immunogenicity of a 2-dose heterologous vaccination regimen with Ad26.ZEBOV and MVA-BN-Filo Ebola vaccines: 12-month data from a phase 1 randomized clinical trial in Uganda and Tanzania. J Infect Dis. 2019; 220: 46-56 Crossref PubMed Scopus (75) Google Scholar across various epidemiological settings. Additionally, African participants included malaria-naive individuals from a high-altitude setting (Nairobi, Kenya) and individuals with partial immunity to malaria (Mwanza, Tanzania, and Masaka, Uganda). This strategic approach led to the generation of locally relevant data and provided a robust evidence base to inform the selection of Ad26.ZEBOV as a prime and MVA-BN-Filo as a boost for phase 2 clinical trials. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trialThe Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children. Full-Text PDF Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trialThe Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults. Full-Text PDF
Read full abstract