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AIDS vaccine trials raise widespread ethical concern

The first large-scale trials of potential AIDS vaccines are set to start early this year in Thailand and China, amid widespread concerns over the ethical issues raised by running drug and vaccine trials in developing nations.

The Thai trial is a joint project of the US Army and the armed forces of Thailand, with the candidate vaccine to be tested on Thai military recruits. According to the US Defense Department, the trial was due to start in late 1993 but has been delayed because the trial protocol is still under review by the Thai government and the World Health Organisation (WHO).

In 1991, WHO announced that it had chosen four developing countries — Uganda, Rwanda, Brazil and Thailand — in which to run large vaccine trials once potential vaccines were available. But whether it is possible to run properly ethical trials - to the standard which would be demanded in developed nations - in the Third World remains a matter of dispute between AIDS professionals and community activists.

According to Manuel Pinto, director general of the Uganda AIDS Commission: ‘Uganda will participate in vaccine trials basically because we are as interested as anyone else in trying to find a vaccine or a cure for AIDS.’

But a Ugandan doctor, who did not wish to be named, said: ‘I’ve seen situations where people have been used in trials of drugs and vaccines who have certainly not benefited from the fruits of such research.’

WHO has insisted that independent ethics committees be set up in each of the four countries where trials of the vaccine are to begin. Nonetheless, difficult ethical dilemmas will remain which the trials will have to address.

‘AIDS is a condition which is - in theory - 100 per cent preventable,’ said Dr Carel Ijseelmuiden, of the Medical University of Southern Africa, in South Africa. ‘The people you’re going to try your vaccine on must be given information and condoms.’

The ethical problem is immediately clear: trial participants must be both protected from and exposed to HIV. But how much effort should be made to prevent exposure?

‘We need to do everything possible to prevent infections, knowing that we will not prevent all of them,’ said Jose Esparza, of the WHO global programme on AIDS.

Issues of informed consent, the stigma resulting from HIV seropositivity, confidentiality and the pressure on people to participate in the trial are also causing intense debate both within WHO as well as the communities where trials will run.

The stakes are undoubtedly high: the potential to prevent AIDS is a prize few can ignore, to say nothing of the enormous financial rewards to be reaped by the company developing the first effective vaccine. Yet, in the search for this most modern of holy grails, there are sure to be more than a few losers.