DoHDST

South African AIDS Vaccine Initiative (SAAVI)  Established in late1999 by the South African government.  Based at the Medical Research Council of South Africa (MRC).  Tasked to develop an affordable, effective & locally relevant preventative HIV vaccine for southern Africa.  SAAVI’s national mandates are to:  Create an enabling environment in South Africa to develop and test novel HIV vaccines.  Create opportunities for scientific and clinical collaboration with global partners.

SAAVI network Ethical issuesCommunity involvement Making the vaccines Actuarial assessments Immunology assessment AnimalHuman Testing the vaccines Behavioural science Data & bioinformatics

Definition of an HIV vaccine  A substance that teaches the body to recognise and defend itself against HIV.  Causes a response from the immune system (the body’s defence system) preparing it to fight if exposed to the virus/bacteria at a later time.  Generally contain harmless particles or copies of particles of the virus which cannot cause HIV infection or AIDS.  Does not contain any live HI virus.

SAAVI’s candidate vaccines (UCT) ProductStatus DNA-gag-rt-tat-nef//envPre-trial manufacture completed, almost completed preclinical toxicity testing in animals, and regulatory review to follow in MVA-gag-rt-env-nef-tatPre-trial manufacture nearing completion. Preclinical toxicity in animals and regulatory review to be done in Plant-based VLPsPreclinical laboratory development phase. BCGPreclinical laboratory development phase. SalmonellaPreclinical student project.

SAAVI’s candidate vaccines (US) ProductStatus Aspergillus proteinPreclinical development phase. SHIVPreclinical development phase.

Clinical trials Two phase I clinical trials started in November 2003 at the Soweto and Durban trial sites – the VEE clade C candidate HIV-1 vaccine which is also being tested in the USA – the HIV.A MVA which has already been in trials in Kenya, the UK and Uganda Made SA the first African country to run multiple, concurrent trials. VEE was the first clade C vaccine to be tested in the world.

Clinical trials Two additional phase I trials are awaiting approval and could start soon – Merck’s adeno-based candidate – IAVI’s adeno-associated candidate Three wholly South African-developed test vaccines are being manufactured for trials & have entered the regulatory approval processes (FDA). These could go to trial in 2005.

Funding Institution Dept. of HealthR10,000,000 Dept. of Science & TechnologyR15,000,000R20,000,000 EskomR15,000,000 Impala PlatinumR 500,000 NIH for DNA manufactureR 600,000 TransnetR 1,500,000 In addition, the European Union has awarded a grant of R10,354,500 to Masikhulisane, SAAVI’s Community Involvement Programme.

Masikhulisane SAAVI COMMUNITY INVOLVEMENT PROGRAMME A South African society working in a mutually beneficial and meaningful partnership with researchers within a vibrant human and legal rights environment. VISION MISSION A sustainable, accountable, learning organisation, founded on a human rights ethos, to ensure an informed and educated South African society with strengthened, active, and sustained community involvement in the AIDS vaccine development process.

STRATEGIC GOALS KEY FOCUS AREAS To promote a human rights culture with regard to the AIDS vaccine development process To facilitate strategic collaboration locally, regionally, & internationally on community involvement in the AIDS vaccine development process To promote sustainable community involvement in AIDS vaccine development process To create & increase awareness of the AIDS vaccine development process To develop an effective, efficient, accountable & sustainable learning organisation Law, Human Rights & Ethics Communication, Education, Training & Development Organisational Development & Strategic Collaboration

Organogram Medical Research Council Contracting organisation Medical Research Council Contracting organisation Citizens, Organisations and Community Structures Reference Group (to be established in 2005) Reference Group (to be established in 2005) SAAVI Management SAAVI Director SAAVI Management SAAVI Director Masikhulisane Management Project Manager Masikhulisane Management Project Manager Law, Human Rights & Ethics Legal Advisor Law, Human Rights & Ethics Legal Advisor Information & Knowledge Management Information Specialist Information & Knowledge Management Information Specialist HIV Vaccine Education Vaccine Educators: KZN, Gauteng, Western Cape HIV Vaccine Education Vaccine Educators: KZN, Gauteng, Western Cape Communications, Education, Training Development Materials Developer Communications, Education, Training Development Materials Developer Project Administration Administrator Project Administration Administrator European Commission

How we work Nationally and provincially In sectors such as: – NGOs, CBOs, AIDS Service organisations – Women, youth – Traditional healers – Education, health – Trade unions In same sectors in and around the trial sites

Contact details Head office Telephone: (021) Fax: (021) Medical Research Council, Francie van Zijl Drive, Parow Valley, 7505 Info-Line: 080 VAC CINE /