First trial of the HIV-1 vaccine in Africa: Ugandan experience

doi:10.1136/bmj.324.7331.226

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Roy D Mugerwa (profrdm@imul.com), professora,
Pontiano Kaleebu, scientific research officerb,
Peter Mugyenyi, directorc,
Edward Katongole-Mbidde, headd,
David L Hom, assistant professore,
Rose Byaruhanga, chief counsellorc,
Robert A Salata, professorf,
Jerrold J Ellner, professorg
and the HIV-1 Vaccine Trial Group

^aSee also Clinical review p 211 Department of Medicine, Makerere University Medical School, Kampala, Uganda,
^b Medical Research Council, Uganda Virus Research Institute, Entebbe, Uganda,
^c Joint Clinical Research Center, Kampala, Uganda,
^d Uganda Cancer Institute, Kampala, Uganda,
^e Clinical Research Group of the New Jersey Medical School, University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07107-3000, USA,
^f Department of Medicine, Division of Infectious Diseases, Case Western Reserve University, University Hospitals of Cleveland, Cleveland, Ohio 44106-5083, USA,
^g New Jersey Medical School, Newark, New Jersey 07103-2714, USA

Correspondence to: R D Mugerwa

Accepted 22 November 2001

Problems in setting up the first trial of an HIV-1 vaccine in Uganda are described here by Mugerwa and colleagues. The authors explain how they solved these problems and give suggestions to help researchers who are starting future trials of HIV vaccines

Trials of the HIV-1 vaccine have been conducted in Europe, North America, Brazil, China, and Thailand.1 The first trial of a candidate vaccine in Africa was recently completed in Uganda. It involved a randomised, placebo controlled trial of a vaccine in healthy volunteers at low risk of HIV infection. 2 3 The vaccine, called “ALVAC-HIV,” uses a live recombinant canarypox vector to express envelope and core genes of HIV-1.

Many commentators predicted that it would be difficult to conduct trials of HIV vaccines in developing countries because of scientific, sociobehavioural, ethical, and logistical barriers.4^–8 Before we started the trial in Uganda, we gathered data to help us overcome these potential barriers. We collected epidemiological9 and sociobehavioural10 data about people who had participated in studies that looked at preparing for trials of the HIV vaccine. These data showed the prevalence and incidence of HIV, behaviours placing people at risk of becoming infected with HIV, and the social acceptability of a vaccine against HIV.9^–11 The people received detailed education and counselling about infection with HIV and about HIV vaccines, and we recruited some for our trial.11 We organised three open workshops at the HIV candidate vaccine trial workshop in Kampala in 1996 to gain consensus from scientists, policy makers, community representatives, and the media about how to undertake research into HIV vaccines.

Despite these initiatives to solve problems before the trial began, we still encountered many barriers. In this article, we discuss these barriers …