Involving National Coordinating, Regulatory and Ethical Bodies in HIV Vaccine Preparedness in Nigeria; The Canadian-Nigerian Collaboration Experience Evaezi.

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Presentation transcript:

Involving National Coordinating, Regulatory and Ethical Bodies in HIV Vaccine Preparedness in Nigeria; The Canadian-Nigerian Collaboration Experience Evaezi Okpokoro MBBS, MPH Institute of Human Virology, Nigeria; Study Manager, Nigerian Canadian Collaboration On AIDS Vaccine (NICCAV) Funding: Canadian Global Health Research Initiative (GHRI, CIDA, CIHR, CHVI & IDRC) Afri-Can Synchronicity Forum Laico Lake Victoria Hotel Entebbe 17 _ 19 Jan 2013 GHRI/CHVI/CIDA/IDRC /CIHR

Background Paucity of high level clinical trials in Nigeria with stigmatization and sensitivities from past suboptimal clinical trials Why? 1.Limited trained investigators (therefore there is a need for more regulatory oversight) 2.Poor mentorship national agencies personnel's in clinical trials 3.Inadequate trained regulatory agencies for study approvals and poor supervisory oversight 4.Inadequate investment from the Government GHRI/CIDA/IDRC/CIHRGHRI/CHVI/CIDA/IDRC /CIHR

NICCAV OBJECTIVES NICCAV objectives are: 1.Preparing the National Coordinating, regulatory and ethical bodies for future HIV Vaccine clinical trials through capacity building 2.Identify and train a research team and ensure community involvement 3.Develop a research laboratory GHRI/CIDA/IDRC/CIHR GHRI/CHVI/CIDA/IDRC /CIHR

Methodology 1.The 3 main national coordinating agencies in HIV, research and vaccine were identified with early involvement and contractual agreement: National Agency for Control of AIDS (NACA) National Health Research Ethics Committee (NHREC) National Agency for Food and Drug Administration Control (NAFDAC) 2.Trainings (trainees and trainers were identified) 3.Meetings (e.g. stakeholders meeting) 4.Site based visits GHRI/CIDA/IDRC/CIHRGHRI/CHVI/CIDA/IDRC /CIHR

Result (Trainings) TrainingsTraineesRemarks Statistical Methods and Epidemiology 8 persons involving NACA, NAFDAC, NHREC and research team Successfully completed Research Ethics training 12 persons involving NHREC and the research team ALL GCLP compliant Introductory course on Clinical trials 5 persons among the research team Regulatory & monitoring of Clinical Trials 3 persons from NAFDAC and IHVN 2 persons were denied visas GHRI/CHVI/CIDA/IDRC/ CIHR

Results (Trainings) Research Ethics training at Plasvirec Introduction to Clinical trial course GHRI/CHVI/CIDA/IDRC /CIHR

Conclusion 1.Our research team and regulatory bodies are GCLP compliant 2.There is higher level of response from the national coordinating agencies with strengthen partnerships 3.These trained officers now oversee the on-going serodiscordant study with a higher level of commitment and team work 4.The research team participated in the development of National Vaccine plan 2012 Early interaction, integration and contractual agreements of national coordinating agencies is critical for building in-country capacity for vaccine trial GHRI/CHVI/CIDA/IDRC /CIHR

Acknowledgements Sophia Osawe; Pam Datong; Aminu Yakubu; Paul Orhii; John Idoko; Gary Garber; Alash’le Abimiku PLASVIREC, Jos Research team Officers of the National Agencies Local Community and study participants Organizers of this forum GHRI, CIHR, CHVI, CIDA, IDRC GHRI/CHVI/CIDA/IDRC /CIHR

Discussions & Comments GHRI/CHVI/CIDA/IDRC /CIHR