Vaccine helps prevent HIV infection
“These new findings represent a major step forward in research on HIV vaccines,” says Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, which provided major funding and other support for the study. “For the first time, an investigational vaccine has shown some ability to prevent HIV infection among those vaccinated. Further research is needed to better understand how this scheme the vaccine reduced the risk of HIV infection, but certainly this is an encouraging development for HIV vaccine field.
“We thank the study staff in Thailand and the United States for their years of effort in successfully conducting this study and the study participants and the people of Thailand for its longstanding support research into vaccines against HIV” adds Dr. Fauci.
Thailand Phase III study of HIV vaccine, also known as RV144, opened in October 2003. The placebo-controlled trial tested the safety and efficacy of a prime-boost regimen of two vaccines: the ALVAC HIV vaccine (the first dose), a modified canarypox vaccine developed by Sanofi Pasteur, headquartered in Lyon, France, and AIDSVAX B / E vaccine (booster dose), a glycoprotein 120 vaccine developed by VaxGen Inc., and is now licensed for Global Solutions for Infectious Diseases (GSID), headquartered in South San Francisco, California, vaccines are based on the subtype B and E, HIV strains that normally circulate in Thailand. The strain of HIV subtype B is most commonly found in the United States.
Led by principal investigator Supachai Rerks-Ngarm, MD, of the Thai Ministry of Public Health, Department of Disease Control, the study was funded by the U.S. Army in collaboration with NIAID, Sanofi Pasteur and GSID . The trial, conducted in Rayong and Chon Buri province of Thailand, enrolled 16,402 men and women 18 to 30 years of age at different levels of risk for HIV infection. Study participants received the ALVAC HIV vaccine or placebo at enrollment and again after 1 month, 3 months and 6 months. The AIDSVAX B / E vaccine or placebo was given to participants at 3 and 6 months. The participants were tested for HIV every 6 months for 3 years. During each clinic visit, are advised on how to avoid HIV infection.
In the final analysis, 74 of 8198 placebo recipients became infected with HIV compared with 51 of the 8197 participants receiving the vaccine regimen. This level of effectiveness in preventing HIV infection was considered statistically significant. The vaccine regimen had no effect, however, in the amount of virus in the blood of volunteers who have acquired HIV infection during the study.
“The Thailand study shows why the field of HIV vaccines must adopt a balanced approach to conduct both basic research necessary to discover and develop new vaccines against HIV and, where appropriate, testing of vaccines in people,” says Margaret I. Johnston, Ph.D. ., Director of NIAID’s Vaccine Program of Research, Division of AIDS. “Both possibilities offer essential information continues to help us better understand what it takes to develop an HIV vaccine completely protected.”
NIAID and collaborating partners are working with other scientific experts to determine the next steps, including further investigation of the RV144 vaccine regimen and the need to consider the impact of these new findings on other candidate HIV vaccine.
Persons who have acquired HIV infection during their trial participation in Thailand have provided access to HIV care and treatment, including highly active antiretroviral therapy based on the guidelines of the Thai Ministry of Public Health.
For more information about the Thai Phase III HIV vaccine trial, please see: http://www.hivresearch.org
Provided by National Institutes of Health
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