Inter Press Service - July 11, 2000
Marc Perelman

For it is there that the first systematic test of an HIV vaccine in Africa has been carried out over the last year and a half. The preliminary result of this study is being released this week in Durban, South Africa during the 13th International AIDS Conference.

Even though its scope is limited and its results uncertain, the trials will likely induce further testing in Africa, where more than 70 percent of the world's 34 million people with HIV/AIDS live.

"They proved one thing to the world: a vaccine trial can be conducted in Africa with high scientific and ethical standards," said Mary Allen, a researcher with the US National Institute of Allergy and Infectious Diseases (NIAID), which sponsored the initiative.

After years of wrangling and passionate debates, the government of Uganda finally agreed to start the clinical trials in February 1999 in co- operation with NIAID. Eminent Ugandan cardiologist Roy Mugerwa was designated to supervise the trials of the canary pox-based Aventis-Pasteur ALVAC vCP205 vaccine in phase I (less than 100 persons). At the time, it was already being tested in France (phase I) and the US (phase II) on some 800 HIV-negative people.

Mugerwa, who also teaches at Makerere University in the capital Kampala, is a leading expert on AIDS in Africa. Now in his fifties, he is part of a team of local doctors who were pioneers in diagnosing the first known AIDS cases in his country back in the early 1980s and who then successfully lobbied the government to raise public awareness about the virus.

As a result, Uganda is one of the very few countries where the infection rate has fallen in recent years.

These same scientists were instrumental in proving the link between HIV and AIDS - a link that is disputed by a small group of "dissident" Western scientists whose website caught the eye of South African President Thabo Mbeki while he was on the Internet one night, searching for an explanation of this terrible figure: 20 percent of South Africans are infected with HIV.

One of the most famous efforts by Ugandan scientists has been the much-publicised Rakai Project, a study group created 10 years ago in the most AIDS-stricken region of Uganda.

Last year, preliminary research conducted by local and US scientists at Mulago Hospital in Kampala found that the use of a drug called Neviparine (NVP) cut the risk of mother-to-child transmission by 50 percent. This finding was particularly important because in Uganda, Neviparine is about 70 times cheaper - and more efficient in this specific case - than the anti- retroviral drug AZT.

Forty Ugandan volunteers - men and women, married and single, between the ages of 18 and 40, all HIV-negative - were chosen. They were given preliminary check-ups to establish both their good health and social behaviour. One of the prerequisites was to have had no more than one sexual partner in the past year.

The volunteers were then randomly divided into three groups: 20 received the actual vaccine - containing some of the genes responsible for the production of HIV proteins - 10 received a canary pox vaccine for rabies and the 10 were given a placebo. Each patient got four injections over six months. Blood samples were drawn and mixed with the virus in the laboratory to see if there were immune responses against HIV itself or against cells infected by HIV.

"There was no risk for the patients," said Mugerwa. "We gave them substances containing genes of the HIV virus which cannot become the virus itself. The idea is that these substances must induce the body to think that the HIV virus is indeed present and that he must produce anti-corps."

A US scientist who was associated with the project confirmed that no volunteer was inadvertently infected.

When the trials were launched, there were many concerns about their feasibility. Were the material conditions good enough in a country where health care is poor? Were the ethical guidelines for such testing respected?

"We were very careful to ensure that both medically and ethically, the trials would be sound," said Mugerwa. "The standards were the same as in the Western world."

The volunteers all signed release forms and had the potential risks of the experiment thoroughly explained to them. "They were motivated because they are surrounded by people who died or are dying of AIDS," he added.

The study lasted one year and preliminary results will be presented in Durban. The volunteers will be monitored until February 2001 to follow up. For now, there is no phase II testing planned for the vaccine.

However, there were and still are some objections. First, the vaccine targets HIV1-B, a strain found mostly in Europe and the United States, while Uganda is predominantly affected by the HIV 1-A and D types. As a consequence, some wonder why the Ugandan researchers are testing a vaccine that would be useful mainly in the West.

"No, we think this vaccine will eventually also be efficient against the type of virus hitting us here in Africa," said Mugerwa. "You don't necessarily need to create a vaccine related to the type of virus." In medical terms, this is called a cross-reactive immune response.

The second criticism concerns access to the potential vaccine. Will Ugandans be able to afford it, when most of them cannot afford the available anti-retroviral drugs - which cost about eight times the average salary?

There is already a rather discouraging precedent with the Hepatitis B vaccine, which was first tested in Senegal before being commercialised at a price beyond most Africans' reach.

"We are very much aware of this danger," said Mugerwa. "But by being part of this process from the very beginning, we were able to negotiate with Pasteur and UNAIDS so as to ensure that if a vaccine is found, it will be affordable. I understand the worries, but we have to take the risk because AIDS is our number one problem. And there is only one way to solve it: a vaccine."

The results will most likely not be spectacular, given the limited scope of the trial. But the very fact that clinical trials were successfully conducted on African soil is itself an achievement. If anything, its has ignited new initiatives.

A new set of clinical tries for a vaccine - developed at the Institute of Human Virology at the University of Maryland biotechnology institute - is being discussed with the Ugandan Health Ministry, yet another indication of the serious job done by Mugerwa and his colleagues. It is promoted by the International AIDS Vaccine Initiative (IAVI), a non-profit organisation created in 1996 to ensure the development of safe, effective and accessible HIV vaccines.

The objective is to move promising experimental vaccines into clinical trials as quickly as possible. IAVI insists on the need to conduct tests in Africa in order to find a vaccine appropriate for the continent, an indirect criticism of earlier tests aimed at "Western" strains of HIV.

"We are currently negotiating and just waiting for the agreement to be signed," said Vijay Mehra, who is responsible for the Ugandan project at IAVI. "We then intend to start the trials by the end of next year."

IAVI, in co-operation with Oxford University in Britain, is planning to start trials in Kenya a few months from now. And it hopes to do the same in South Africa early next year.

IAVI has also signed specific intellectual property and technology- transfer agreements to ensure that a vaccine will be accessible, and recently issued a blueprint calling for simultaneous access to an AIDS vaccine in both rich and poor countries.

This would be the ultimate reward for Roy Mugerwa and his African peers. (END/IPS/HE/mp/da/00).
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