GLOBAL: Highest ethical standards needed in HIV/AIDS vaccine trials

NAIROBI, 21 Sep 2003 (PLUSNEWS) - AIDS experts gathered in Kenya on Saturday urged drug companies, governments and affected communities to observe the highest ethical standards in the race to develop an HIV/AIDS vaccine.

Elisabeth Ngugi, a researcher at the University of Nairobi, warned against people being coerced into taking part in vaccine trials, either by communities who give a 'block consent' or families. As the search continues for an HIV/AIDS cure and vaccine, community 'policing' was necessary, she said. Poor people and women were particularly vulnerable, as "in many locations, particularly in Africa, women do not have the right to make decisions," she noted at a symposium on aids vaccines, held on the eve of the 13th International Conference on AIDS and sexually transmitted infections in Africa (ICASA).

It was also essential that people were fully informed of any risks involved in trials, the process they were going through, and all of the research findings by the companies involved, Ngugi stressed. "It doesn't matter whether the person has ever seen the doors of a school or not, that person must be made to understand," she added.

It will be at least three or five years before large-scale trials are started on any vaccine, according to the International Aids Vaccine Initiative (IAVI).

IAVI European Director Dr Frans Van den Boom told IRIN it was "crucial" that whole communities, not just individuals, were involved in the trial process. They needed to be fully informed and educated, so that once a vaccine had been developed it could be distributed as quickly as possible.

Similarly, infrastructure had to be developed by governments to allow the distributions to take place.

Van den Boom added that companies developing the vaccines were bound by a number of ethical obligations, such as ensuring that test groups had access to vaccines once they were finally placed on the market, and providing treatment for anyone who became infected with the human immuno-deficiency virus during trials. "It is essential that we give back something to those communities even where there are failures," he said.

Two decades into the HIV/AIDS pandemic, only one vaccine trial - conducted among about 8,000 people in the Netherlands, the United States and Canada - has been completed.

The results showed the vaccine to be ineffective but proved for the first time that human trials were possible and that participation did not give people a false sense of safety, making them engage in risky behaviour.

Currently, nine approved vaccines are being tested worldwide, including six in Africa - one in Botswana, two in Kenya, two in South Africa, and one in Uganda.

They are all early safety studies, involving fewer than 100 people each, to monitor any side effects or negative reactions to the drugs. Later studies will be conducted with a much larger group of people and reveal whether the vaccines actually protect against HIV.

The number of versions of HIV is on the increase worldwide, due to mutations and 'recombinations' - when a person is infected with more than one virus and these exchange genomes to form a new variant.

HIV trial vaccines are constructed using small pieces of the virus called 'immunogens', with the aim of boosting the body's defence system.

The 13th International Conference on AIDS and sexually transmitted infections in Africa (ICASA) is being held in Nairobi, Kenya from 21 to 26 September.

[ENDS]