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Patricia Fast MD, Ph.D. CMO, International AIDS Vaccine Initiative

Canada-IAVI Collaborative Synergies in Africa. Patricia Fast MD, Ph.D. CMO, International AIDS Vaccine Initiative. Afri -CAN Synchronicity Conference Entebbe 19 January 2013. IAVI Today. Integrated organization that links our …. Industry-style labs and diverse research portfolio .

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Patricia Fast MD, Ph.D. CMO, International AIDS Vaccine Initiative

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  1. Canada-IAVI Collaborative Synergies in Africa Patricia Fast MD, Ph.D. CMO, International AIDS Vaccine Initiative Afri-CAN Synchronicity Conference Entebbe 19 January 2013

  2. IAVI Today Integrated organization that links our … Industry-style labs and diverse research portfolio Academic, government and private-sector partnerships Network of clinical trial centers in Africa Advocacy and outreach from community to international level

  3. IAVI-SupportedClinical Research Centers (Africa & India) 2001 - 2012 IAVI and partners evaluated: 13 HIV vaccine candidates in 25 Phase I/IIa clinical trials in 11 countries in Asia, Africa, Europe and North America. 13 Trials in Africa

  4. Clinical and laboratory standardizationis critical UVRI-IAVI lab and clinic, Entebbe, Uganda • After lab/clinic constructed • Clinic: Multiple Phase I AIDS vaccine trials • Laboratory: Validated assays; Good Laboratory Practices training • Regional Reference Ranges • Accredited Good Clinical Laboratory Practices;Gates Foundation/CAVD reference lab • LSRII flow cytometry, gene arrays

  5. Kaplan Meier curve of time to AIDS by infecting HIV-1 subtype P=0.05, log-rank test Protocol C data from 12 Jan, 12

  6. Major Sites on HIV Env Targeted by bnAbs identified at the structural level Dual glycan, V3(2G12, PGT 120-135) V1V2 Peptide-glycan(PG9/16, CH01) CD4 binding site(b12, VRC01, PG04, CH31) membrane proximal domain + lipid (2F5, 4E10, 10E8) PG= IAVI Protocol G

  7. Informed Consent Good participatory practice, www.unaids.org Guidelines for biomedical HIV prevention trials Early ‘beta-test’ assessment by AVAC of IAVI collaborative network Culturally appropriate assessment of understanding Assessment of Understanding (AoU) Informed Consent studies: Mixed methods include narrative/discussion

  8. Canada-IAVI Collaborations & Synergy:KAVI • Canada-UON collaboration: epidemiology, immunology of HESN • KAVI founded by UON with MRC-UK and IAVI. • Multiple clinical trials • Expanded mucosal immunology • IAVI support for GCP, GCLP, VaxLit • With GHRI support, KAVI is a regional resource, conducting GCP, GCLP and technical training as well as Vaccine Literacy and Advocacy

  9. Canada-IAVI Collaborations & Synergy:CANSSA • Three CANSSA clinical sites have long-term collaborations with IAVI. • ZEHRP, Lusaka (& Ndola) and Project San Francisco, Kigali • Couples VCT, Reproductive Health, Epidemiology & Trials • HIV Pathogenesis Program, UKZN, Durban • IAVI support for laboratory development

  10. Canada-IAVI Collaborations & Synergy:UVRI Clinical trial to explore innate immune response to Yellow Fever Vaccine in Uganda IAVI support for clinical trial at UVRI-IAVI unit Through CAPT-N, Canadian Trials Network managed data Rafik Sekaly (Montreal/Florida) supervised microarray work—UVRI sent scientist to conduct assays Uganda responses differ from European-- may show a pre-vaccination motif that predicts responsiveness.

  11. Opportunities • Goal: independent clinical research units in Africa, able to do epidemiology and interventional trials alone or in collaboration • Epidemiology is a ‘moving target’. Current key populations include: • Young people, especially women in S Africa • MSM in coastal Kenya (and elsewhere) • Mobile populations such as in fishing villages & mining communities

  12. Challenges:“Capacity Building” for a more complex era • Prepare for large to huge interventional trials • Move beyond the basics • EXAMPLE: Fishing Villages • Access to care (mobile clinics? ) • Epidemiology & needs assessment • Participant tracking via fingerprint technology • Social science research: motivation & adherence

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