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

Ethical issuesCommunity involvement

Making the vaccines

Actuarial assessments

Immunology assessment

Animal Human

Testing the vaccines

Behavioural scienceData & 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)

 

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 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, 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 Citizens, Organisations and Community Structures

Reference Group(to be established in 2005)

Reference Group(to be established in 2005)

SAAVI ManagementSAAVI Director

SAAVI ManagementSAAVI Director

Masikhulisane ManagementProject Manager

Masikhulisane ManagementProject Manager

Law, Human Rights & Ethics

Legal Advisor

Law, Human Rights & Ethics

Legal Advisor

Information & Knowledge

ManagementInformation Specialist

Information & Knowledge

ManagementInformation Specialist

HIV Vaccine Education

Vaccine Educators:KZN, Gauteng, Western

Cape

HIV Vaccine Education

Vaccine Educators:KZN, Gauteng, Western

Cape

Communications, Education, Training

DevelopmentMaterials Developer

Communications, Education, Training

DevelopmentMaterials Developer

Project AdministrationAdministrator

Project AdministrationAdministrator

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) 938-0552Fax: (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