DoH
DST
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
Making the vaccines
Immunology assessment
Animal
Actuarial assessments
Testing the vaccines
Human
Data & bioinformatics
Community involvement
Behavioural science
Ethical issues
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)
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.
SAAVI’s candidate vaccines (US)
Product
Status
Aspergillus protein
Preclinical development phase.
SHIV
Preclinical 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
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
R
500,000
R
600,000
500,000
NIH for DNA manufacture
Transnet
R 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
VISION
A South African society working in a mutually beneficial and meaningful
partnership 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.
STRATEGIC GOALS
To promote a
human rights
culture with
regard to the
AIDS vaccine
development
process
To create &
increase
awareness of the
AIDS vaccine
development
process
To promote
sustainable
community
involvement in
AIDS vaccine
development
process
To facilitate strategic
collaboration locally,
regionally, &
internationally on
community involvement
in the AIDS vaccine
development process
To develop an
effective,
efficient,
accountable
& sustainable
learning
organisation
KEY FOCUS AREAS
Law, Human Rights &
Ethics
Communication, Education,
Training & Development
Organisational
Development & Strategic
Collaboration
Organogram
Medical Research Council
European
Commission
Contracting organisation
SAAVI Management
SAAVI Director
Reference Group
(to be established in 2005)
Project Administration
Masikhulisane Management
Administrator
Project Manager
HIV Vaccine
Education
Law, Human
Rights & Ethics
Vaccine Educators:
Legal Advisor
KZN, Gauteng, Western
Cape
Communications,
Education, Training
Development
Information &
Knowledge
Management
Materials Developer
Information Specialist
Citizens, Organisations and Community Structures
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:
Fax:
(021) 938-0552
(021) 938-0823
Medical Research Council,
Francie van Zijl Drive, Parow Valley, 7505
Info-Line: 080 VAC CINE / 080 822 2463
www.saavi.org.za