Involving National Coordinating, Regulatory and Ethical Bodies in HIV Vaccine Preparedness in...

Involving National Coordinating, Regulatory and Ethical Bodies in HIV Vaccine Preparedness in Nigeria;

The Canadian-Nigerian Collaboration Experience

Evaezi Okpokoro MBBS, MPHInstitute 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 ForumLaico Lake Victoria Hotel Entebbe 17_19 Jan 2013GHRI/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

trials3. Inadequate trained regulatory agencies for study

approvals and poor supervisory oversight4. 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


Methodology1. 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


Result (Trainings)Trainings Trainees RemarksStatistical 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


Conclusion1. Our research team and regulatory bodies are GCLP

compliant2. There is higher level of response from the national

coordinating agencies with strengthen partnerships3. 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


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


Discussions & CommentsGHRI/CHVI/CIDA/IDRC/CIHR

Involving National Coordinating, Regulatory and Ethical Bodies in HIV Vaccine Preparedness in...

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