PANOS London: Tuesday, December 17, 1996.
Helen Epstein and Lillian Nsubuga

The trial will show how safe the vaccine is and, if successful, lead to much larger trials involving thousands of Ugandans in 1998. Only when these trials have been completed, which could take until the year 2005, will scientists know whether the vaccine can protect against HIV infection. Despite this long development period, the vaccine is prompting hopes of a real breakthrough against HIV/AIDS in developing countries.

The ALVAC VCP205 vaccine, as it is technically known, contains live virus like the vaccines against polio and smallpox. It is a genetically engineered version of the canaripox virus, which causes disease among canary birds but not in humans, carrying several small, harmless fragments of HIV. The vaccine has already been tested on more than 100 volunteers in France and the United States who have shown no ill effect.

A vaccine that effectively blocks HIV infection is urgently needed to stem the tide of HIV in poor communities around the world. Every day about 8,500 people become infected with HIV, ninety per cent of them in developing countries.

An affordable vaccine which only needs to be administered once is believed to be a much more effective medical solution to the AIDS epidemic than expensive drug treatments. During 1996 major gains have been made in developing drugs against HIV/AIDS, but at about 12,000 dollars for each person's annual treatment, these are cripplingly expensive and are unlikely to benefit developing countries. Despite the international importance of developing a vaccine, only about 1% of all international research funding has been spent on vaccine research.

But the development of an AIDS vaccine has proved far more difficult than researchers hoped when HIV was first discovered in the 1980s, and research has been beset both by lack of funds and, as in Uganda, by rows over testing.

An intense and sometimes acrimonious public debate has surrounded the ALVAC vaccine trial in Uganda. The September meeting was organised by the vaccine trial organisers and brought together over 200 representatives of the medical and religious communities, legal experts, counsellors, policy experts and the media. The meeting helped to allay concerns voiced in highly critical attacks in the Ugandan media, and in street demonstrations, which centred on claims that Ugandans were being used as guinea pigs to test a vaccine from which they may never benefit.

Most critics now appear to be satisfied. "We were very concerned at the beginning of this process, but now we are assured that the vaccine is safe", says Samuel Tindifa of the Faculty of Law at Makerere University.

The main reason for public acceptance of the trials seems to be the apparently high ethical standards being applied to the trials by the organisers. In collaboration with the National Institutes of Health in the US, the trial organisers at the Joint Clinical Research Centre (JCRC) in Uganda have spent almost five years preparing a cohort of young male soldiers to participate in an AIDS vaccine trial in anticipation of one becoming available for testing. The forty participants in the upcoming trial will be chosen from those ranks. Using military men in Africa makes sense because they are a mobile, sexually active group, and have a high risk of HIV infection.

One of the biggest concerns was whether the tests would really be voluntary. Anyone taking part in such trials must give their "informed consent" under the rules of the Helsinki Declaration on Human Rights. Concern was strong because the volunteers were soldiers from the Ugandan army, who are used to following orders.

In response to criticism, Major Rubamira Ruranga, who works as an AIDS counsellor for the JCRC argues that volunteers are lining up for the injections. "They want to be part of the struggle," says Major Ruranga who is HIV positive himself and is founder of the National Network of People Living with HIV/AIDS.

Dr JosÄ Esparza of the Joint United Nations AIDS Programme (UNAIDS) that is overseeing the trial says that "every precaution has been made to ensure that this is voluntary." However the trial organisers did adopt the workshop's recommendation that the individuals who counsel prospective volunteers be drawn from outside the armed forces.

Concern over the trial has also focused on whether the vaccine will be affordable in Uganda if it is shown to be effective. The annual per capita health expenditure in Uganda is around five dollars. UNAIDS acknowledges this as a problem. "It's very difficult at this stage to ensure availability of a vaccine. We must get the companies to agree to the next stage of the trials first. It's very difficult to negotiate for a product you don't even know exists," says Esparza. Negotiations about pricing are expected to begin once large scale trails are underway.

Finally, worries also surround whether the vaccine will be appropriate for use by Ugandans at risk of HIV infection. There are ten different strains - or subtypes - of HIV in the world. An ideal HIV vaccine would protect against all strains. However, most vaccines currently being developed, including the one being tested in Uganda, are designed to provide the greatest level of protection against strain B, which predominates in North America and Europe. In Uganda, strains A and D predominate. Many workshop participants questioned the wisdom and the motivation behind testing a subtype B vaccine in Uganda.

According to Professor Excler of Pasteur Merieux, A and D strain ALVAC vaccines have been produced already, and the company is in the process of scaling up production. If the results from the B strain vaccine are encouraging, a larger scale trial with the A and D versions will begin soon afterwards.

Uganda is now in the process of establishing its own review committee which will oversee all future medical research in the country. The high ethical standards apparently being applied to the trial together with the open public debate surrounding it should, according to Esparza, be "held up as a model for other countries".

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