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, vol. 13, pp. 1829829

Abstract

BACKGROUND: 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.

Authors 12

1. Jonathan Kitonsa corresponding

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

2. Abu-Baker Ggayi

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

3. Zacchaeus Anywaine

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

4. Eva Kisaakye

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

5. Laura Nsangi

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

6. Vincent Basajja

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

7. Mary Nyantaro

   MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

   Affiliation as printed

   Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda

8. Deborah Watson‐Jones

   London School of Hygiene & Tropical Medicine

   Affiliation as printed

   London School of Hygiene and Tropical Medicine, London, UK

9. Georgi Shukarev Aachen Janssen Vaccines & Prevention B.V Clinical Development

   Janssen (Netherlands)

   Affiliation as printed

   Janssen Vaccines and Prevention B.V., Clinical Development, Leiden, The Netherlands

10. Ine Ilsbroux

    Janssen (Belgium)

    Affiliation as printed

    Janssen Research & Development, Portfolio Delivery Operations, Global Development, Beerse, Belgium

11. Cynthia Robinson Aachen Janssen Vaccines & Prevention B.V Clinical Development

    Janssen (Netherlands)

    Affiliation as printed

    Janssen Vaccines and Prevention B.V., Clinical Development, Leiden, The Netherlands

12. Pontiano Kaleebu

    MRC/UVRI & LSHTM Uganda Research Unit · Uganda Virus Research Institute

    Affiliation as printed

    Medical Research Council, Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda