FOR RELEASE
January 31, 2002
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| GlaxoSmithKline Corporate Media Relations: Martin Sutton at Tel: + 44 20 8966 8256
GlaxoSmithKline Corporate Media Relations US: Nancy Pekarek at Tel: +1 215 751 4232
GlaxoSmithKline Biologicals: Anne P Walsh at Tel: + 32 2 656 9831.
HIV Vaccine Trials Network Communications contact: Jeremy Barnicle, APCO Worldwide, at Tel: +1 206-239-0157
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Start of first clinical trial with Glaxosmithkline Biologicals' HIV vaccine
The first human trial with GlaxoSmithKline Biologicals’ (GSK Biologicals) candidate HIV vaccine will test whether the vaccine, which prevented AIDS in rhesus monkeys, is safe and immunogenic in humans.
Rixenstart, Belgium - Today, GlaxoSmithKline Biologicals (GSK Biologicals) announces the start of the first trial in humans of its recombinant, adjuvanted candidate HIV vaccine - NefTat and gp 120 formulated with the proprietary adjuvant AS02. The main objectives are to see if the candidate vaccine is safe and whether the human immune system responds to it.
The first human clinical trial of GSK Biologicals’ candidate HIV vaccine will be conducted in collaboration with the HIV Vaccine Trials Network (HVTN) in the USA, following the encouraging results from rhesus monkey efficacy studies and other clinical studies on novel adjuvants. The HVTN is sponsored by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health.
“The HVTN welcomes the opportunity to collaborate on this trial with GSK, which brings acknowledged global expertise in vaccine development to the field of HIV vaccine research,” said Dr. Larry Corey, Principal Investigator for HVTN. “The testing of multiple vaccine candidates is critical to speeding progress toward an HIV vaccine and controlling the global pandemic, and we are pleased to offer our clinical trial network to vaccine inventors.”
This phase I safety and immunogenicity trial will start at up to 11 clinical research centres in the U.S. Healthy male and female adult volunteers who are HIV seronegative and who are at low risk of HIV infection will be enrolled in this clinical trial. The HVTN will begin volunteer recruitment for the trial early 2002.
In earlier trials, GSK Biologicals’ candidate HIV vaccine has protected rhesus monkeys from a highly pathogenic and partially heterologous simian-human immunodeficiency virus (SHIV), a very potent virus similar to HIV. The animals maintained their CD4-positive cell counts (levels of helper cells in the immune system which initiate an immune response), and also exhibited a strongly reduced viral load for 24 months. This unique vaccine candidate appears to be highly effective against the development of disease in a non-human primate model. The direct relevance of these animal studies to humans is not known. Human data can be obtained only from human studies.
“GSK Biologicals is committed to developing an HIV vaccine that will prevent AIDS and reduce transmission of HIV both in the developed and the developing world” said Jean Stéphenne, President and General Manager GSK Biologicals. “Consequently, we will be developing our vaccine candidate against at least two of the most prevalent strains of HIV as well as studying the effect of these vaccines across different clades of the virus”.
HIV Vaccine Trials Network
The HIV Vaccine Trials Network was established by the National Institute of Allergy and Infectious Diseases in 1999 to foster the development of HIV vaccines through testing and evaluating candidate vaccines in clinical trials. The network has the capacity to conduct all phases of clinical trials, from evaluating candidate vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Spanning four continents, the network includes 25 clinical sites, an operations and statistical and data management center, and a central laboratory.
GlaxoSmithKline: A Leader in Healthcare
GlaxoSmithKline Biologicals, the world’s leading vaccine manufacturer, is located in Rixensart, Belgium. Rixensart is the centre of all GlaxoSmithKline’s activities in the field of vaccine research, development and production. GSK Biologicals employs over 900 research scientists who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections which cause serious medical problems worldwide. In the year 2000 GSK Biologicals distributed over 1.1 billion doses of vaccines to 177 countries, an average of 35 per second. Teams of researchers are actively working on future vaccines against malaria, HIV, TB, Strep. pneumoniae, rotavirus and many other diseases of global importance
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Background information on HIV and AIDS:
AIDS is caused by the infection with a virus called human immunodeficiency virus (HIV). The virus is contracted through blood transfusions, sexual contact and via infected needles. HIV destroys a specific kind of blood cells, CD4-positive T cells (helper cells), which are crucial to the normal function of the human immune system. In the development of AIDS, loss of these cells in people with HIV is an extremely powerful predictor of disease. According to the World Health Organisation, an estimated 36.1 million people are living with HIV world-wide with approximately 15,000 more people being infected each day.
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