South African AIDS Vaccine Initiative (SAAVI)

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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.
• SAAVIs 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.

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SAAVI network
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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
  bodys 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.

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SAAVIs candidate vaccines (UCT)
Product Status
DNA-gag-rt-tat-nef//env Pre-trial manufacture completed, almost completed preclinical toxicity testing in animals, and regulatory review to follow in 2005.
MVA-gag-rt-env-nef-tat Pre-trial manufacture nearing completion. Preclinical toxicity in animals and regulatory review to be done in 2005.
Plant-based VLPs Preclinical laboratory development phase.
BCG Preclinical laboratory development phase.
Salmonella Preclinical student project.
 
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SAAVIs candidate vaccines (US)
Product Status
Aspergillus protein Preclinical development phase.
SHIV Preclinical development phase.
 
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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.

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Clinical trials

• Two additional phase I trials are awaiting
  approval and could start soon
• Mercks adeno-based candidate
• IAVIs 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.

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Funding
Institution 2004 2005
Dept. of Health R10,000,000 R10,000,000
Dept. of Science Technology R15,000,000 R20,000,000
Eskom R15,000,000 R15,000,000
Impala Platinum R 500,000 R 500,000
NIH for DNA manufacture R 600,000
Transnet R 1,500,000
In addition, the European Union has awarded a
grant of R10,354,500 to Masikhulisane, SAAVIs
Community Involvement Programme.
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Masikhulisane SAAVI COMMUNITY INVOLVEMENT
PROGRAMME
VISION
A South African society working in a mutually
beneficial and meaningfulpartnership with
researchers within a vibrant human and legal
rights environment.
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.
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STRATEGIC GOALS
KEY FOCUS AREAS
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Organogram
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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

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Contact details
Head office Telephone [phone] Fax
[phone] Medical Research
Council,Francie van Zijl Drive, Parow Valley,
7505 Info-Line 080 VAC CINE / 080 822
2463 www.saavi.org.za