flosz schreef:
[quote=flosz]
'Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck’s ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in late 2007 or early 2008 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.
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Press Releases
February 8, 2007
First Large-Scale HIV Vaccine Trial in South Africa Opens
Four-year trial will enroll 3,000 participants throughout South Africa
A large-scale clinical trial of a candidate HIV vaccine—which previously showed promise in smaller studies in the United States and elsewhere—has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.
Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.
“Our best hope of ending the AIDS epidemic is a safe and effective vaccine,” says NIH Director Elias A. Zerhouni, M.D. “To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers.”
In South Africa the trial is called Phambili (“moving forward”). Also known as HVTN 503, it is a Phase IIb “test-of-concept” trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.
In smaller trials, the vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers. To date, more than 1,800 people have received at least one injection. Two years ago, the first Phase IIb trial of the vaccine opened at sites in the United States, Canada, South America, Australia and the Caribbean (see
www3.niaid.nih.gov/news/newsreleases/..., areas where a subtype of HIV called clade B predominates. That trial is ongoing.
www.hvtn.org/media/pr/phamni.html