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February 28, 2007
New York, New York -- The AIDS Vaccine Advocacy Coalition (AVAC) heralds today's launchof the first African efficacy trial of an experimental HIV vaccine as a critical, strategic and historically-significant step in the search for an AIDS vaccine.
The trial, which is known as Phambili (a Xhosa word meaning "moving forward") or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.
"South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).
The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.
"The timing of the Phambili trial launch is a bold decision," said Warren. "There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries."
"As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population," Warren said.
"Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and publicprivate partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate," Warren said.
While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.
About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a nonprofit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit www.avac.org.