Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodies
- *Corresponding Author:
- Evaezi Okpokoro
Institute of Human Virology, Nigeria
Tel: +234 8058460765
E-mail: [email protected]; [email protected]
Received Date: September 30, 2013; Accepted Date: October 30, 2013; Published Date: November 04, 2013
Citation: Okpokoro E, Osawe S, Datong P, Yakubu A, Ukpong M, et al. (2013) Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodies. J AIDS Clin Res 4:260. doi:10.4172/2155-6113.1000260
Copyright: © 2013 Okpokoro E, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: There is paucity of high-level clinical trials in Nigeria for several reasons, which include: lack of trained investigators and mentorship in the implementation of Clinical trials at international standard; inadequate investment and trained regulatory agencies to provide oversight. Therefore, the need for capacity of the national coordinating agencies (NCA); the investigative team, supporting research laboratory and the community to be developed in preparation for future HIV prevention trials including vaccine trials.
Method: In collaboration with the University of Ottawa, three regulatory agencies (NAFDAC -National Agency for Food and Drug Administration Control, NHREC- National Health Research Ethics Committee and NACA-National Agency for Control of AIDS) were identified for capacity building. We developed a phase IIB mock clinical trial model for the purpose of capacity building which created a platform for hands-on training alongside mentoring, meetings, site base visits with full community engagement.
Result: Eight trainees from NACA, NHREC, NAFDAC and the investigative team completed biostatistics and epidemiology course; three trainees attended a Clinical Trial course at the Institute of Human Virology Nigeria and had additional 2-day training/mentoring at the University of Ottawa and thereafter these trainees conducted a 2-day site assessment of the ongoing sero-discordant study in Jos, Nigeria with full community engagement. A trained research team is a member of the national HIV vaccine plan implementation committee and the supporting research laboratory has updated all standard operating manuals for ISO15198 accreditation.
Conclusion: Sustained interaction/integration through trainings/mentorship of National Coordinating Agencies and investigative team promotes commitment relevant for building in-country capacity for successful HIV vaccine clinical trial. An on-going vaccine preparedness HIV sero-discordant couple’s cohort is being used to apply principles and concepts of this structure and the trainings in preparation for future HIV prevention including vaccine trials.