A novel vaccine targeted to multiple HIV subtypes found worldwide has moved into the second phase of clinical testing, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced today. The study investigators plan to enroll a total of 480 participants at sites in Africa, North America, South America and the Caribbean to test the safety and immune response to the vaccine.
The experimental vaccine was developed by scientists at NIAIDs Dale and Betty Bumpers Vaccine Research Center (VRC) and is being studied in the HIV Vaccine Trials Network (HVTN), a clinical research collaboration funded by NIAIDs Division of AIDS (DAIDS).
"This trial marks an important step in the advancement toward an AIDS vaccine. The rapid development of this candidate vaccine--less than five years since the launch of the VRC--underscores our commitment to hasten the day when we have an effective AIDS vaccine," says NIAID Director Anthony S. Fauci, M.D.
Half of the 480 trial participants will be enrolled in the Americas (Haiti, Jamaica, Brazil and the United States) and half in southern Africa (Botswana and South Africa). The geographic diversity of participants allows the researchers to evaluate whether the immune responses generated to the vaccine vary according to the amount of prior exposure to adenovirus, as measured by pre-existing levels of adenovirus antibodies. Africans, for example, generally have had greater exposure to adenovirus than people living in North America.
The participants, divided into two groups, will receive four injections spread out over a period of six months. One group will receive three injections of the naked DNA component followed by a booster injection of the adenoviral vector component. The second group will receive four injections of a placebo vaccine consisting of sterile saltwater. Because the study is "double blind," neither the participants nor the researchers will know whether a volunteer is receiving the study vaccine or the placebo until the end of the trial.
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