The first two participants in the IAVI study, which tests the safety and immunogenicity of a candidate vaccine named HIVA.MVA in healthy HIV-uninfected volunteers, were dosed on the morning of November 12th at the Perinatal HIV/AIDS Research Unit at Baragwanath Hospital in Soweto, Johannesburg.

This was a moment of historic significance for South Africa, which has one of the world’s highest HIV infection rates. Other Phase I trials with this IAVI vaccine have already been conducted at the University of Nairobi, the University of Oxford, the UK Medical Research Council and the Uganda Virus Research Institute. Johannesburg-based Triclinium is also in charge of monitoring the Uganda trial.

The two first South African trials were initiated a few days apart. “By testing multiple AIDS vaccine candidates at once, each designed differently, South Africa will help speed the time to success,” said Dr. Seth Berkley, President and CEO of IAVI. “A preventive vaccine is our best hope to stop the spread of the epidemic.”

A second South African site, the HIV Vaccine Research Unit of the Medical Research Council in Durban, will shortly commence enrolling volunteers into this study, which also includes Switzerland and other sites in Europe.

The vaccine is based on HIV sub-type A, which is prevalent in East Africa and the Ukraine.  It is related to the viruses found in West Africa and Thailand.  A similar vaccine based on sub-type C is being developed in Cape Town by the South African Aids Vaccine Initiative. 

Of considerable relevance to the search for a universal vaccine is the possibility of cross reactivity. The present study will show if the IAVI vaccine induces a significant immune response against subtype A and cross reactivity against subtype C.

The successful application to conduct this study was compiled by Triclinium and submitted in April 2003 to the South African Medicines Control Council (MCC) which approved it in August.

Only a year earlier, the MCC created a HIV/AIDS Vaccine Committee specifically for the purpose of reviewing such studies, which are expected to multiply during the next decade.

The MCC also held a workshop in Pretoria in February 2003 at which stakeholders were given the opportunity to the draft Guidelines for the Conduct of HIV/AIDS Vaccine Trials. Both IAVI and Triclinium representatives attended this meeting.

This IAVI trial plans to enrol a total of 55 volunteers in South Africa. Each will receive one primer followed by two booster doses of vaccine over six months and be followed up for a further twelve months.

The first vial administered in the study

Local Community Advisory Board member Matilda Mogale watches Principal Investigator Dr Eftyhia Vardas administer the first dose of HIVA.MVA. The first participant, aged 22, agreed to be photographed and interviewed. Afterwards, at an international press conference with investigators and members of the Community Advisory Board, she said she had volunteered for the benefit of humankind.

Watched by staff of the Bargawanath PHRU, Bruce Johnson of IAVI (left), Dr Eftyhia Vardas (centre) and Study Chairman Prof James McIntyre (right) discuss data recorded in the first Case Report Form by Co-Investigator Dr Mampedi Bogoshi.