Human clinical trials of an HIV vaccine are expected to begin next week, GlaxoSmithKline Biologicals (GSK Biologicals), the company that owns the vaccine announced on January 31.
Human trials are necessary to test the efficacy and safety of the vaccine, which prevented AIDS in rhesus monkeys. While the vaccine failed to stop the transmission of SHIV (the simian version of HIV) in monkeys, it did suppress the virus to nearly undetectable levels, according to earlier findings that were published in March.
The monkeys exhibited a strongly reduced viral load for two years. However, human trials are necessary to determine how humans will respond to this vaccine.
Phase I of the trial -- the segment that tests primarily for safety, and not efficacy -- will start in more than 10 research centers throughout the United States. Adult volunteers who are HIV negative and who are at low risk of HIV infection will be recruited early this year. More than 80 people are expected to enroll over fifteen months.
If the results of the trial are promising and if the vaccine is deemed safe, larger scale testing will begin and will take two to four years.
"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 Stphenne, 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".
Human trials will be conducted in collaboration with the HIV Vaccine Trials Network (HVTN) in the USA. The HVTN is sponsored by the National Institute of Allergy and Infectious Diseases part 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."
4 Feb 2002
first human trials of HIV vaccine to begin
Clinical trials of a potential HIV vaccine are expected to begin next week, GlaxoSmithKline Biologicals, the company that owns the vaccine announced on January 31.