Sunday Times (Johannesburg) - Sunday June 29, 2003
Claire Keeton

These volunteers are all HIV-negative and have been meeting since March to prepare for the trial, which will last at least 12 months.

They are among about 150 volunteers who are prepared to risk harmful side-effects and the possibility of being stigmatised after joining the trial, which could start in August, depending on whether initial vaccine shots on US volunteers satisfy the safety data.

None of the volunteers is paid for their time-consuming commitment. But this group - mostly fit young men - have decided to go ahead despite the risks, in the hope of saving lives.

"I see a lot of people dying and there is no cure," said Zikalala, who lives in Diepkloof, Soweto, with his mother and daughter of 10. They live on his mother's pension as Zikalala has no job. He has matric - volunteers are required to have at least 12 years' education so they are not exploited.

Zikalala is positive about what the trial involves. "They will give me the vaccine and my body will react to it. I may feel sick and my body may become infected but not with HIV/Aids.

"The doctors will treat any infection and it will be cured since it is not a killer like HIV," he said.

Many of the volunteers have seen friends or family members die from the epidemic, which is killing an estimated 600 people a day in South Africa. Dr Glenda Gray, principal investigator of the trial said: " Many of the youth here from Soweto are highly motivated and have made a personal commitment to fighting Aids. They are the 'young lions' of today."

One 23-year-old woman added: "I was not around the struggle of 1976 but today I want to fight Aids. My aunt died in 2000 of Aids."

Another Soweto man, 33, said: "I thought Aids was a punishment and trusted my ancestors to protect me. But then I discovered some family members were positive and realised we were not untouchable. I feel being part of this trial is a calling for me."

Like many of the volunteers, Zikalala joined after going for voluntary counselling and an HIV test at Baragwanath's testing and trial division, a bright and clean wing in a former nurses' home. The counsellors are friendly and provide rapid results. Testing HIV-negative, being in good health and over 18 years of age are requirements to qualify for the trial, which will involve 48 volunteers in the US and 48 in South Africa.

"It is a great milestone. South Africa is at the forefront of global vaccine initiatives and the vaccine being tested is tailor-made for us," said Dr Tim Tucker, director of the South African Aids Vaccine Initiative (SAAVI).

But the vaccine being tested is still in a very early stage of development and it is not yet known if it will trigger the appropriate immune response.

"We must not create the impression that we are close to a vaccine and raise expectations that are not met," the Director- General of Health, Dr Ayanda Ntsaluba, warned on Friday.

The first phase of the trial - the first in the world to test a vaccine for the subtype C virus, which is common in South Africa - will be based at two sites: Baragwanath's HIV/Aids Vaccine Division and the Medical Research Council/SAAVI Research Unit in Durban. The first 12 volunteers will get three injections with low vaccine doses at four-week intervals to test the dosage and side-effects.

The trials for various effective vaccines could last about 10 years, according to Tucker.

If the first phase of testing shows the vaccine to be safe, the second phase will proceed with up to 400 low-risk and high-risk participants. The third phase could involve from 5 000 to 10 000 high-risk participants.

All the volunteers will receive risk-reduction counselling and condoms to prevent HIV - and half of them will be given the vaccine and the rest a placebo.

This type of vaccine poses no risk of infection and has satisfied international safety standards.

"To drive a car you need an engine and, if you take the engine out, you can't drive the car. We are only using a piece of the gene and it is impossible to remake [the HI virus]," Gray explained.

But the fear of being infected by an Aids vaccine is widespread, said the community outreach director at Baragwanath's Aids Division, Matilda Mogale, an energetic nurse with an exuberant laugh.

Members of the Soweto trial have been assured that they will receive antiretroviral treatment if they became infected from their own behaviour during the trial.

Finding a vaccine is urgent, Gray emphasised. "We know how to prevent HIV/Aids, but we are not preventing it. Vaccines have been used in the past to eradicate and manage devastating diseases."

Meanwhile Professor Malegapuru Makgoba, who chairs the Africa vaccine programme for UNAIDS, and 23 other international Aids researchers proposed in the journal Science on Friday that top scientists need to co-ordinate their efforts to accelerate the development of an Aids vaccine.

Anyone wanting to volunteer for the trial can contact the HIV Vaccine InfoLine on 0808-222-463.

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