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GHRI/CIDA/IDRC/CIHR. Afri -Can Synchronicity Forum Laico Lake Victoria Hotel Entebbe, Uganda 17 _ 19 Jan 2013. OVERVIEW: Creating A C ommon P latform for HIV Vaccine R esearch and HIV Care and Treatment Program: Nigerian Canadian Collaboration On AIDS Vaccine (NICCAV) Study
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GHRI/CIDA/IDRC/CIHR Afri-Can Synchronicity ForumLaico 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/CIHR 5.8 5.4 5.0 4.6 4.5 4.4 3.8 1.8 1991 ’93 ’95 ’99 ‘2001 ’03 ’05 ‘08 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) • 2nd ranked globally for HIV burden • 4th ranked for TB burden globally • 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
GHRI/CIDA/IDRC/CIHR AIDS Care and Treatment in Nigeria IHV-Nigeria Structure IHV - Nigeria IHV - Nigeria IHVN Treatment and Research Training Care CDC NIH AVERT CDC Acute PEPFAR NIH Fogarty HIV Infection PHE APIN - Gates CDC Peds GCC HIV CDC UTAP Foundation Malignancy PMTCT CDC Pre- and In- Servie Training Doris Duke GFATM HSS,Malaria HIV, TB CHRI (NICCAV) CDC NeuroAIDS Adherence • Collaborate with: • 8 major Universities • 20 National Specialist Hospitals & Federal Medical Centers NIH - IHV NIH H3Africa TB - HIV Nigeria AR Clinical Trial Unit
GHRI/CIDA/IDRC/CIHR 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 • 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. • Access to Highly Active Antiretroviral Therapy (HAART) through large programs like the US PEPFAR has significantly enhanced infrastructural capacity and life quality and expectancy • However, an effective HIV vaccine (s) remains the best hope of ending the epidemic . National HIV vaccine plan developed since 2001 and has been recently updated with plans for NACA coordinated implementation by partners, institutions and NGOs.
GHRI/CIDA/IDRC/CIHR NICCAV Study Rationale CRF06_cpx A unique HIV subtype G, CRF02 A/G epidemic that accounts for about 40% of the population at the epicenter of the HIV pandemic CRF02_AG Common HIV-1 subtypes in: Nigeria • West Africa Subtype G
GHRI/CIDA/IDRC/CIHR Study Goal 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
1) Discordant couples cohortCounseling 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 GHRI/CIDA/IDRC/CIHR Objective 3. Building laboratory capacity to support HIV vaccine Trials Building clinical, Regulatory and Community capacity Central Implementing body • 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 Objective 1. Training in HIV Vaccine Ethics and Regulation • Institute of Human Virology, University of Maryland SOM • IHV-UMD Fogarty Training in Nigeria on Epidemiological research tools • Institute of Human • Virology-Nigeria • Administration of grant • Study protocol implementation • Overall oversight • University of Ottawa, Canada • Training in HIV vaccine clinical trials capacity • Training in regulatory oversight Develop one research laboratories at study site to be fully GCLP compliant
GHRI/CIDA/IDRC/CIHR Trainings • 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 http://www.ihvnigeria.org/ihvnweb) • Statistical Methods in Epidemiology • Research Ethics and Regulatory Affairs http://www.westafricanbioethics.net/wabcms • https://www.citiprogram.org. • 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.MorenikeUkpong)
GHRI/CIDA/IDRC/CIHR Objective 1Training of Regulatory Bodies
GHRI/CIDA/IDRC/CIHR Training of Study team
Objective 2:Cohort Characteristics GHRI/CHVI/CIDA/IDRC/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.
GHRI/CIDA/IDRC/CIHR Community Engagement Led by NHVMAS, Dr. Ukpong (a sub grantee) • 16 Civil Society Organization formed • 10 member CAB members with monthly trainings on research literacy • 10983 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 WHO-AFRO Guidance for SLIPTA Implementation • SLIPTA Guidelines finalized during the consultative meeting held in Nairobi, Kenya in July 2011. • Established to institute a Laboratory quality improvement process & implementation in a stepwise manner • Framework for countries to improve national laboratory services towards ISO 15189 standard • Country owned program
Scoring and Star Levels End Point Link to Accreditation Body 5 Star 4 Star 3 Star ≥ 95 % 2 Star 85-94 % Certificate of Recognition 1 Star 75-84% Scores (%) 55-64 % 0 Star 65-74 % Stepwise Process
PLASVIREC Plateau State Human Virology Research Center (PLASVIREC) GHRI/CIDA/IDRC/CIHR 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 15189 Accreditation
GHRI/CIDA/IDRC/CIHR Conclusions • 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. • 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 • National bodies and the local community are critical for awareness and support for HIV vaccines. • Continuous mentoring is required to have effective bodies to review very complex HIV vaccine protocols and monitor these trials • 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/CHVI/CIDA/IDRC/CIHR Acknowledgement • Study participants • Dr. MorenikeUpkpong, 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