After almost two years of consultation, the Joint United Nations Programme on HIV/AIDS (UNAIDS) has released its version of guidance points for HIV vaccine trials. The guidelines will be an important point of reference for developing countries, where many such trials are likely to take place.

One issue that has dominated the discussions leading to the release of this document is the level of care and treatment given to participants who become infected with HIV during the course of a trial ( Nature Med. 4, 874; 1998). Guidance point 16 of the document advises that “a consensus on the standard of care and treatment, its duration, and who will bear the costs” should be reached before a decision is made to begin HIV vaccine testing, and says, “Sponsors should seek, at a minimum, to ensure access to a level of care and treatment that approaches the best proven care and treatment that are attainable in the potential host country.”

Guidance point 16 goes on to recommend that such a care package should try to include anti-retroviral therapy, tuberculosis prevention and treatment, treatment for other sexually transmitted diseases, prevention/treatment of opportunistic infections, counselling and palliative care, including pain control and spiritual care.

Activists Peter Lurie and Sidney M. Wolfe of the Public Citizen's Health Research Group have been quick to respond to the document. Although in a letter to the executive director of UNAIDS, Peter Piot, they say that the effort is an improvement over previous language, they go on to write that it still leaves large loopholes that most researchers can exploit.

For example, by asking vaccine developers to provide treatment “at a level consistent with that available in the host country,” they claim that UNAIDS has played into the sponsors hands, as this statement gives “just enough wiggle room for researchers to provide no or inadequate treatment to those acquiring HIV infection during the trial in countries where anti-retrovirals are not available.”

The 18-point guidance document states that “HIV preventive vaccine trials should only be carried out in countries and communities that have appropriate capacity to conduct independent and competent scientific and ethical review,” and that “The research protocol should outline the benefits that persons participating in HIV preventive vaccine trials should experience as a result of their participation.”

In other vaccine news…

Credit: Courtesy of SmithKline Beecham Pharmaceuticals

Last month saw a commercial boost for the Global Alliance for Vaccines and Immunizations (GAVI) (Nature Med. 6, 238; 2000), with large vaccine donations by four pharmaceutical companies, valued at US$150 million. Merck pledged a donation of one million doses per year for five years of the hepatitis B vaccine Recombivax; American Home Products will donate 10 million doses of hemophilus influenza type-B conjugate vaccine; SmithKline Beecham is to expand its African pediatric malaria vaccine program, conducted in collaboration with the US Walter Reed Army Institute and the UK's Medical Research Council; and Avenits is to donate 50 million doses of polio vaccine. GAVI has received requests for these and other vaccines from countries with incomes of less than US$1,000 per capita GNP—26 from Africa, 11 from Eastern Europe, 6 from Asia, 3 from Latin America and 1 from the Middle East.