Kitonsa, Jonathan; Ggayi, Abu-Baker; Anywaine, Zacchaeus; Kisaakye, Eva; Nsangi, Laura; Basajja, Vincent; Nyantaro, Mary; Watson-Jones, Deborah; Shukarev, Georgi; Ilsbroux, Ine; +2 more... Robinson, Cynthia; Kaleebu, Pontiano; (2020) 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. GLOBAL HEALTH ACTION, 13 (1). 1829829-. ISSN 1654-9716 DOI: https://doi.org/10.1080/16549716.2020.1829829
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Abstract
BACKGROUND: The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by Ebolaviruses with over 28,000 human cases and 11,325 deaths. The World Health Organisation (WHO) declared the epidemic a public health crisis that required accelerated development of novel interventions including vaccines. The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit (MRC/UVRI & LSHTM Uganda Research Unit) was among the African research sites that implemented the VAC52150EBL1004 Ebola vaccine trial. OBJECTIVE: We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct. METHODS: Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented. RESULTS: Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a 'phased' study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation. CONCLUSION: The use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.
Item Type | Article |
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Faculty and Department |
Faculty of Infectious and Tropical Diseases > Dept of Clinical Research MRC Uganda > UG-HIV Care |
Research Centre | Vaccine Centre |
PubMed ID | 33073737 |
Elements ID | 152071 |
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Filename: Implementation of accelerated research strategies for implementation as applied in a phase 1 Ad26.ZEBOV, MVA-BN-Filo two-dos.pdf
Licence: Creative Commons: Attribution-Noncommercial 3.0
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