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