Prior to exposure

Point of transmission

After infection

•Male and female condoms

•Antiretroviral therapy (mother-to-child)

•Post exposure prophylaxis (PEP)

•Antiretroviral therapy

•Care

•Education & Behavioral change

•Education & Behavior change•Male circumcision

•Preventive Vaccines

•Pre-exposure prophylaxis (PrEP)

•HSV2 suppression

•Microbicides

•Diaphragm, cervical barriers & new FCs

•Therapeutic Vaccines

The context of SAAVI activities: HIV and AIDS prevention methodologies & Research

Momentous Occasion July 2009• SAAVI MVA-C designed by SAAVI Scientists, constructed and

manufactured in USA and SAAVI DNA-C2: constructed in SA and manufactured in USA.

• University of Cape Town/ SAAVI/MRC/NIAID• FDA and MCC approval end 2008: • Launch of SAAVI 102/HVTN073 Phase 1 HIV Vaccine Clinical trial :• The trial involves 36 people at two sites in South Africa – one in Cape

Town and one in Gauteng - and 12 people in the USA and will primarily assess safety.

• All vaccinations completed• Jointly supported by SAAVI, HVTN, NIAID• Possible future trials:• SAAVI 103 and Amended SAAVI102

The pitfalls and highlights of working with only Government Support

• 31 December 2007 ESKOM Funding not renewed [own situation]• 30 March 2008 Department Science and Technology Funding not renewed [DST

Scientific and financial review following different model and SAAVI Governance model concern]

• 2009 -2010 R10 million NDOH• 2010 – 2011 submitted SAAVI Business Plan to NDOH in May 2010 awaiting

response• 2009 – 2012 through the SA and Italian Government Collaboration R 38 million• Ministry of Foreign Affairs [Direzione Generale per la Cooperazione allo

Sviluppo]; COOPERAZIONE ITALIANA• and• ISS [Istituto Superiore di Sanità]• “Program to support the Ministry of Health of South Africa in the

implementation of a national program of global response to HIV & AIDS”

Italy/SA Project description : MRC/SAAVI/ISS /NDOH

General Objective

Control and reduction of HIV/AIDS spreading in the selected areas

Component 1

Development and strengthening of the health service governance and health care system governance skills (Health Service component)

Component 2

GMP-certified manufacture of vaccines in SA (Production Component)

Component 3

Improvement on site of the skills to conduct HIV/AIDS vaccine clinical trials (Clinical Trials Component)

Current and possible future SAAVI Research Funding and support Priorities

• Basic Laboratory Sciences: University of Cape Town

• Clinical Trial Sites Capacity: 6 Sites

• Ethics, Human and Legal Rights research, social sciences

• Business and Operational Structure [SAAVI Directorate and MK, MRC Delft Rhesus Maque Unit]

• With NDOH and SA/I Collaboration

• 9 Researchers 2009-2012

SAAVI Funded Research Activities [NDOH 2009-2010 and 2010-2011]

• Category 1: UCT: Prof A-L Williamson: maintaining the operation of the UCTVRG GLP-compliant Facility

• Category 2 and 3: UCT, DTHC, Prof L G Bekker: Building additional capacity with a focus on community preparation and community involvement and Socio-behavioral studies

• Category 2: Aurum Institute for Health Research; Prof G Churchyard: Support for the conduct of HIV vaccine trials in Klerksdorp[Matlosana]

• Category 3: Wits University, PHRU: Prof G Gray: Developing and validating a cultural and age appropriate risk reduction counselling intervention for adolescent HIV vaccine trial participants

• Category 4: MRC Delft Rhesus Macaque Unit, Masikhulisane, SAAVI Secretariat

7

2010 2011 2012 2013 2014 2015 2016 2017

Trials areprime-boost

regimenswith

secondaryboost

September 2010

Phase IIbEfficacyPhase IIbEfficacy

RSA and Southern AfricaHeterosexual, high-risk

Objective: Translate vaccine to high-risk groups with greater viral diversity

Partners/Funders: Gates, NIH, HVTN, sanofi pasteur, Novartis RSA, etc.

RV144 Follow-onStudies

RV144 Follow-onStudies

ThailandRV152, RV305, RV306,RV144i laboratory studies

Objective:Determine a correlate of protection for use in future trials; optimize the regimen

Partners/Funders: US Army, Thai Gov’t, NIH, sanofi pasteur

South Africa part of MHRP Product Development

Regional Strategy: Progress of RV 144 “Thai trial”