Implementation of accelerated research: strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dose Ebola vaccine clinical trial in Uganda

References

• Centre for Disease Control. 2014-2016 Ebola outbreak in West Africa. [cited 2019 Oct 31]. Available from: https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html
   Google Scholar
• Rojek A, Horby P, Dunning J. Insights from clinical research completed during the west Africa Ebola virus disease epidemic. Lancet Infect Dis. 2017;17:e280–11.
   Web of Science ®Google Scholar
• World Health Organisation. Ebola Response Roadmap. Geneva: World Health Organisation; 2014.
   Google Scholar
• World Health Organisation. Experimental Ebola vaccines. [cited 2019 Oct 31]. Available from: https://www.who.int/mediacentre/news/ebola/01-october-2014/en/
   Google Scholar
• Kanapathipillai R, Henao Restrepo AM, Fast P, et al. Ebola vaccine — an urgent international priority. N Engl J Med. 2014;371:2249–2251.
   PubMed Web of Science ®Google Scholar
• Calain P. The Ebola clinical trials: a precedent for research ethics in disasters. J Med Ethics. 2018;44:3–8.
   PubMed Web of Science ®Google Scholar
• Osterholm M, Moore K, Ostrowsky J, et al. The Ebola vaccine Team B: a model for promoting the rapid development of medical countermeasures for emerging infectious disease threats. Lancet Infect Dis. 2016;16:e1–e9.
   PubMed Web of Science ®Google Scholar
• Wang Y, Li J, Hu Y, et al. Ebola vaccines in clinical trial: the promising candidates. Hum Vaccin Immunother. 2016;13:153–168.
   Web of Science ®Google Scholar
• Marzi A, Feldmann H. Ebola virus vaccines: an overview of current approaches. Expert Rev Vaccines. 2014;13:521–531.
   PubMed Web of Science ®Google Scholar
• Henao-Restrepo AM, Camacho A, Longini IM, et al. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!). Lancet. 2017;389:505–518.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Kummervold PE, Schulz WS, Smout E, et al. Controversial Ebola vaccine trials in Ghana: a thematic analysis of critiques and rebuttals in digital news. BMC Public Health. 2017;17:642.
   Web of Science ®Google Scholar
• Heymann DL. Ebola: transforming fear into appropriate action. Lancet. 2017;390:219–220.
   Google Scholar
• Oyeyemi SO, Gabarron E, Wynn R. Ebola, Twitter, and misinformation: a dangerous combination? BMJ. 2014;349:g6178.
   PubMedGoogle Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Kisser A, Heininger U, Moorthy VS, et al. Addressing the needs and gaps in safety assessment of vaccines during clinical trials in resource limited countries. Vaccine. 2011;29:4173–4174.
   PubMed Web of Science ®Google Scholar
• Motari M, Ota MO, Kirigia JM. Readiness of ethics review systems for a changing public health landscape in the WHO African Region. BMC Med Ethics. 2015;16:82.
   Web of Science ®Google Scholar
• Wordl Health Organisation. African Vaccine Regulatory Forum (AVAREF). Geneva: World Health Organisation; 2006.
   Google Scholar
• UgandaVirus Research Institute. Research and ethics committee. [cited 2016 Mar 2019]. Available from: https://www.uvri.go.ug/research-ethics-committee
   Google Scholar
• Uganda National Council of Science and Technology. Guidelines and forms. [cited 2016 Mar 2019]. Available from: https://www.uncst.go.ug/guidelines-and-forms/
   Google Scholar
• Medidata. Rave EDC. 2019 [cited 2019 Mar 12]; Available from: https://www.medidata.com/en/products/edc/
   Google Scholar
• Brody BA, McCullough LB, Sharp RR. Consensus and controversy in clinical research ethics. JAMA. 2005;294:1411–1414.
   PubMed Web of Science ®Google Scholar
• Weijer C, Emanuel EJ. Protecting communities in biomedical research. Science. 2000;289:1142–1144.
   PubMed Web of Science ®Google Scholar
• Emanuel EJ, Wendler D, Killen J, et al. What makes clinical research in developing countries ethical? The Benchmarks of ethical research. J Infect Dis. 2004;189:930–937.
   PubMed Web of Science ®Google Scholar
• Strauss RP, Sengupta S, Quinn SC, et al. The role of community advisory boards: involving communities in the informed consent process. Am J Public Health. 2001;91:1938–1943.
   PubMed Web of Science ®Google Scholar
• Winslow RL, Milligan ID, Voysey M, et al. Immune responses to novel Adenovirus Type 26 and modified vaccinia virus Ankara–vectored Ebola vaccines at 1 year immune responses to 2 Ebola vaccines at 1 YearLetters. JAMA. 2017;317:1075–1077.
   PubMed Web of Science ®Google Scholar