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

Prior to exposure. Point of transmission. After infection. Education & Behavior change. Male and female condoms Antiretroviral therapy (mother-to-child) Post exposure prophylaxis (PEP). Antiretroviral therapy Care Education & Behavioral change. Male circumcision Preventive Vaccines

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

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  1. Prior to exposure Point of transmission After infection • Education & Behavior change • Male and female condoms • Antiretroviral therapy (mother-to-child) • Post exposure prophylaxis (PEP) • Antiretroviral therapy • Care • Education & Behavioral change • Male circumcision • Preventive Vaccines • Pre-exposure prophylaxis (PrEP) • HSV2 suppression • TherapeuticVaccines • Microbicides • Diaphragm, cervical barriers & new FCs The context of SAAVI activities: HIV and AIDS prevention methodologies & Research

  2. 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

  3. 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”

  4. Italy/SA Project description : MRC/SAAVI/ISS /NDOH General Objective Control and reduction of HIV/AIDS spreading in the selected areas 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) Component 1 Development and strengthening of the health service governance and health care system governance skills (Health Service component)

  5. 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

  6. 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. South Africa part of MHRP Product DevelopmentRegional Strategy: Progress of RV 144 “Thai trial” Trials are prime-boost regimens with secondary boost 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 Phase IIb Efficacy in Thailand Phase IIb Efficacy SE Asia MSM, high-risk Objective: Demonstrate efficacy in target population to achieve public health impact Partners/Funders: US Army, Thai Gov’t, NIH, sanofipasteur 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 7

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