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

Afri-CAN Synchronicity ConferenceEntebbe

19 January 2013

Canada-IAVI Collaborative Synergies in Africa

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

IAVI-Supported Clinical 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

Clinical and laboratory standardization is critical

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

UVRI-IAVI lab and clinic, Entebbe, Uganda After lab/clinic constructed

Protocol C data from 12 Jan, 12

Kaplan Meier curve of time to AIDS by infecting HIV-1 subtype

0.00

0.25

0.50

0.75

1.00

Pro

porti

on w

ithou

t AID

S

84 67 42 25 15 6D255 215 154 106 61 24C206 169 123 90 59 29A1

At risk

0 1 2 3 4 5Years post infection

A1CD

P=0.05, log-rank test

Major Sites on HIV Env Targeted by bnAbs identified at the structural level

membrane proximal domain + lipid

Dual glycan, V3(2G12, PGT 120-135)

CD4 binding site(b12, VRC01, PG04, CH31)

V1V2Peptide-glycan(PG9/16, CH01)

(2F5, 4E10, 10E8)

PG= IAVI Protocol G

Informed Consent

Good participatory practice, www.unaids.orgGuidelines for biomedical HIV prevention trialsEarly ‘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

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

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

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 unitThrough CAPT-N, Canadian Trials Network managed

dataRafik 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.

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

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