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First Volunteers Injected in Botswana HIV Vaccine Trial For immediate release: 4 July 2003 (Gaborone, Botswana) The Botswana Ministry of Health, together with the Botswana-Harvard AIDS Institute Partnership (BHP) is happy to announce that the study of an experimental vaccine has officially opened with the enrollment and injection of the first two volunteers at the Princess Marina Hospital in Gaborone, Botswana. Volunteers have also been injected at the two trial sites in the United States. This is the first HIV vaccine trial to be conducted in Botswana and in the southern African region. "This study is a significant and hopeful step in Botswana’s battle against the scourge of AIDS," said Joy Phumaphi, Botswana’s Minister of Health. "The volunteers for this trial exemplify the best of the traditional Botswana values of altruism and selflessness. They are true heroes in this fight for our country’s future." Approximately fourteen HIV-negative volunteers will be enrolled in Botswana, and twenty-eight will be enrolled in the United States at sites in Boston, Massachusetts and St. Louis, Missouri. To date, over 30 Batswana have stepped forward to volunteer and two have been enrolled so far in the trial. To qualify for the trial, volunteers must be between the ages of 21 and 40, in general good health, HIV negative, available for 18 months, not pregnant and not planning to become pregnant during the study. The Botswana-Harvard Partnership is continuing to screen potential volunteers for participation in the trial. BHP Chairman Dr. Max Essex, principal investigator for the study, said, "The government of Botswana deserves recognition for the creation of the BHP laboratory and the capacity it has built with trained staff, state-of-the art equipment, and Botswana-specific research. Botswana stands ready to conduct not only this study, but other important HIV research. It is important to stress that the road to a successful vaccine is long and that this Phase I trial is a first step for Botswana on that road." In this study, researchers will look at the experimental vaccine’s side effects to determine its safety at three different doses. Researchers will also examine the body’s immune response to the experimental vaccine. Each volunteer will be followed for at least eighteen months, during which time he or she will be injected four times. Thirty-six volunteers will receive the experimental vaccine and six will receive a placebo. The experimental vaccine is composed of non-infectious components of HIV’s genetic material. "These components do not cause infection, so there is no chance that trial volunteers could get HIV infection or AIDS from receiving the experimental vaccine," said Dr. Joseph Makhema, BHP Co-Director and Senior Clinical Research Manager. The experimental vaccine was developed by Epimmune, a company in San Diego, California. Partners in the trial’s design and implementation are the Ministry of Health (Botswana), the Harvard AIDS Institute, the National Institutes of Health (U.S.), the Harvard Medical School, the HIV Vaccine Trials Network, St. Louis University, and Epimmune. Preparations for HIV vaccine trials in Botswana were aided by the Ministry of Health-appointed National HIV Vaccine Committee, and by a Community Advisory Board which guided the research team and ensured that research-related community concerns were addressed. The Botswana-Harvard AIDS Institute Partnership, established in 1996 by the Government of Botswana and the Harvard AIDS Institute, is dedicated to collaborative research and education activities in the fight against HIV and AIDS. In addition to undertaking HIV-related research relevant to Botswana, BHP engages in large-scale training programs for the country’s health care personnel. The BHP HIV Reference Laboratory is a state-of-the-art research facility of a caliber and scale unmatched in Africa. It is unique in Africa as a laboratory solely dedicated to HIV treatment and research. It currently processes most of the sophisticated HIV-related tests for the country. The laboratory also serves as a training facility, helping to build Botswana’s professional capacity by training the nation’s future researchers and technicians. Contact: In Botswana Carisa Cunningham (267) 390-2671, ext. 2111; cell: (267) 71517986 or Michelle Schaan (267) 390-2671, ext. 2104 In U.S.: Bridín Byrne (617) 432-6106 |