Afri-Can Synchronicity Forum Laico Lake Victoria Hotel Entebbe, Uganda 17 _ 19 Jan 2013 OVERVIEW: Creating A Common Platform for HIV Vaccine Research and HIV Care and Treatment Program: Nigerian Canadian Collaboration On AIDS Vaccine (NICCAV) Study PI: Alash’le G Abimiku, M.Sc; PhD Institute of Human Virology, Nigeria University of Maryland School of Medicine Co PI: Dr. Gary Gaber, MD University of Ottawa, Ottawa Hospital Funding: Canadian Global Health Research Initiative GHRI/CIDA/IDRC/CIH R

1991 ’93 ’95 ’99 ‘2001 ’03 ’05 ‘ Capital City: Abuja Population: 170,123,740 (2012 est) GDP - per capita (PPP): $2,578 (2011 est.) Land Area 910,770 sq km (351,648 sq miles) (slightly more than 2ce the size of California Background on Nigeria HIV Seroprevalence PLWH-2.95m (♂-1.23m, ♀-1.72m) Cumulative AIDS Death- 2.99m (♂-1.38m, ♀-1.61m) Total AIDS orphaned- 2.23million New infection- 380, 000 (Adult- 323,000, Children- 57,000) 2 nd ranked globally for HIV burden 4 th ranked for TB burden globally GHRI/CIDA/IDRC/CIHR

IHV-Nigeria Structure IHV-Nigeria IHV- ResearchTraining Treatment and Care CDC Acute HIV Infection APIN-Gates Foundation PMTCT NIH Fogarty NIH-IHV Nigeria AR CDC UTAP AIDS Care and Treatment in Nigeria NeuroAIDS TB-HIV Doris Duke CDC Adherence CDC PEPFAR PHE GCC HIV Malignancy Clinical Trial Unit NIH AVERT CDC Peds GFATM HSS,Malaria HIV, TB Collaborate with: 8 major Universities 20 National Specialist Hospitals & Federal Medical Centers Nigeria IHVN GHRI/CIDA/IDRC/CIHR CHRI (NICCAV) CDC Pre- and In- Servie Training NIH H3Africa

PEPFAR Laboratory Capacity Building Plateau State Human Virology Research Center (PLASVIREC), Jos PCR, Cell Culture, Serology, PBMCs storage & flow cytometry Asokoro Lab Training Center (ALTC), Abuja PCR and Sequencing National TB and Leprosy Training Center (NTBLTC) Zaria; TB culture & molecular assays GHRI/CIDA/IDRC/CIHR

NICCAV Study Rationale. GHRI/CIDA/IDRC/CIHR 1.Despite a national seroprevalence of 4.1%, Nigeria has the 2nd highest burden of HIV in the world. Additionally being the most populous nation in Africa, it has the highest number persons that would require an effective HIV vaccine, yet not a single HIV vaccine trial has occurred in Nigeria or any part of W. Africa. 2.Access to Highly Active Antiretroviral Therapy (HAART) through large programs like the US PEPFAR has significantly enhanced infrastructural capacity and life quality and expectancy 3.However, an effective HIV vaccine (s) remains the best hope of ending the epidemic 4.National HIV vaccine plan developed since 2001 and has been recently updated with plans for NACA coordinated implementation by partners, institutions and NGOs.

NICCAV Study Rationale GHRI/CIDA/IDRC/CIHR 6.A unique HIV subtype G, CRF02 A/G epidemic that accounts for about 40% of the population at the epicenter of the HIV pandemic Common HIV-1 subtypes in: Nigeria West Africa

Study Goal GHRI/CIDA/IDRC/CIHR NICCAV study goal is to create an internationally certified HIV clinical research site capable of conducting HIV vaccine clinical trials in populations with defined risk of HIV infection using the highest international scientific standard and utilizing the infrastructure developed through PEPFAR

University of Ottawa, Canada Training in HIV vaccine clinical trials capacity Training in regulatory oversight Institute of Human Virology, University of Maryland SOM IHV-UMD Fogarty Training in Nigeria on Epidemiological research tools Objective 1. Training in HIV Vaccine Ethics and Regulation Training of leadership from: National Agency for AIDS Control (NACA) Coordination of National strategic plan and AIDS Vaccine Plan National Agency for Food and Drug Administration and Control (NAFDAC) Approval of protocols for HIV vaccine candidates and oversight National Health Research Ethical Committee (NHREC) Clinical trial protocol approval Clinical trail monitoring 1) Discordant couples cohort Counseling Unit Plateau State Human Virology Research Center (PLASVIREC) 2) Community Participation (NHVMAS) Community mobilization and education campaign linked to cohort development Objective 2. Cohort development and Community Involvement Institute of Human Virology-Nigeria Administration of grant Study protocol implementation Overall oversight Central Implementing body Objective 3. Building laboratory capacity to support HIV vaccine Trials Develop one research laboratories at study site to be fully GCLP compliant Building clinical, Regulatory and Community capacity GHRI/CIDA/IDRC/CIHR

Trainings GHRI/CIDA/IDRC/CIHR Didactic trainings at the Institute of Human Virology (linking with University of Maryland NIH Fogarty program (PI: Blattner) Epidemiology and Research Ethics (also web based Statistical Methods in Epidemiology Research Ethics and Regulatory Affairs Community engagement and education on HIV vaccine trials Community engagement by the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) using the Good Participatory Practice Guidelines (led by Dr. Morenike Ukpong)

Objective 1 Training of Regulatory Bodies TrainingsTraineesRemarks Statistical Methods and Epidemiology 8 persons involving NACA, NAFDAC, NHREC and research team IHVN led training Research Ethics training 12 persons involving NHREC and the research team IHVN led training. ALL are GCLP compliant Introductory course on Clinical trials 5 persons among the research team IHVN led training Regulatory & monitoring of Clinical Trials 3 persons from NAFDAC and IHVN Ottawa led training: 2 persons were denied visas GHRI/CIDA/IDRC/CIHR

Training of Study team Msc Clinical trials at the University of Maryland Baltimore North to South training since Sept last year On site laboratory training at CDC ISO accredited lab Kemri, Kenya 1South to South, Successfully completed and implementing ongoing M & E course at the University of Pretoria, S.Africa South to South. Successfully completed GHRI/CIDA/IDRC/CIHR

Objective 2: Cohort Characteristics GHRI/CHVI/CIDA/IDR C/CIHR 545 Seronegatives enrolled (target is 500) Similar numbers of both genders enrolled 94% retention during up to 9 months follow up 26% never use condoms: 34% inconsistent use Up to 94.3% of HIV+ partners are on HAART through PEPFAR Despite that 25% have viral load of 10,000 to 1.6m 75% have detectable virus load but <10,000 copies Incidence of 0.6% have been recorded in the cohort during this 9 months follow up 34% of the seronegative had hypertension; and 15% had anemia.

Community Engagement 16 Civil Society Organization formed 10 member CAB members with monthly trainings on research literacy person (6091 males, 4892 females) has been informed about NICCAV and HIV vaccines research literacy Two successful media round table discussion published in some newspapers e.g. GHRI/CIDA/IDRC/CIHR Led by NHVMAS, Dr. Ukpong (a sub grantee)

WHO-AFRO Guidance for SLIPTA Implementation  SLIPTA Guidelines finalized during the consultative meeting held in Nairobi, Kenya in July  Established to institute a Laboratory quality improvement process & implementation in a stepwise manner  Framework for countries to improve national laboratory services towards ISO standard  Country owned program GHRI/CIDA/IDRC/CIHR

Scoring and Star Levels Stepwise Process 1 Star 5 Star 2 Star 3 Star 4 Star % % % ≥ 95 % Scores (%) 0 Star End Point Link to Accreditation Body % Certificate of Recognition

Laboratory Accreditation PLASVIREC has improved from 2 star to 4 star (the highest score being 5) on the WHO-AFRO On site laboratory training at CDC ISO accredited lab Kemri, Kenya of Plasvirec Laboratory Manager PLASVIREC currently carrying out the process for ISO Accreditation GHRI/CIDA/IDRC/CIHR Plateau State Human Virology Research Center (PLASVIREC) PLASVIRE C

Conclusions 1.The sero-discordant cohort is still relevant for vaccine studies due the potential for HIV transmission from HIV+ partners with moderate to high viral load despite being on HAART. There is also low condom use; and the presence of STIs. 2.This cohort of exposed person in a normal relationship (as opposed to highly exposed cohorts) is a viable cohort for testing responses to vaccines in an exposed population who may be participating in vaccine trials as “normal” seronegative controls 3.National bodies and the local community are critical for awareness and support for HIV vaccines. 4.Continuous mentoring is required to have effective bodies to review very complex HIV vaccine protocols and monitor these trials 5.Laboratory accreditation of research facility has significantly upgrade the standards of processes at site to ensure high quality samples GHRI/CIDA/IDRC/CIHR

Strategic Future Needs Support for Manuscript and grant writing to capture the success of this funding Sustainable mentoring of regulatory bodies and trained personnel is essential Clinical trials (HIV vaccine Phase I/II or other related trails) is needed to utilize the well characterized cohort; trained research staff; supportive ethical and regulatory bodies, and community; and an accredited laboratory at our site. GHRI/CIDA/IDRC/CIHR

Acknowledgement Study participants Dr. Morenike Upkpong, community leaders and the Community PLASVIREC, Jos Research team Ottawa and Nigeria leadership and investigators Nigerian National Agencies leadership (Prof. Idoko (NACA), Dr. Orhii (NAFDAC); Mr. Yakubu (NHREC) Sponsors: GHRI, CIHR, CHVI, CIDA, IDRC GHRI/CHVI/CIDA/IDRC /CIHR