Prior to exposure Point of transmission After infection Male and female condoms Antiretroviral therapy (mother-to- child) Post exposure prophylaxis (PEP)

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Presentation transcript:

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-ex p osure 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] 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

SAAVI Funded Research Activities [NDOH and ] 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

Trials are prime-boost regimens with secondary boost September 2010 Phase IIb Efficacy Phase IIb Efficacy RSA and Southern Africa Heterosexual, 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-on Studies RV144 Follow-on Studies Thailand RV152, 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 Phase IIb Efficacy in Thailand Phase IIb Efficacy in Thailand SE Asia MSM, high-risk Objective: Demonstrate efficacy in target population to achieve public health impact 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”