Oct. 15, 2001 (SACRAMENTO, Calif.) — A clinical trial testing the safety and tolerability of two investigational AIDS vaccines for healthy individuals is being launched this week at the UC Davis School of Medicine and Medical Center. The study, which is part of a multi-site clinical trial, will enroll up to 126 individuals nationwide. Ten to 20 participants will be recruited into the UC Davis study.
Known as a Phase I clinical trial, the UC Davis study will test the safety and tolerability of genetically engineered vaccines that have been designed to protect the body against HIV infection. Developed by Merck Research Laboratories, the test vaccines include a piece of HIV known as Gag. These next-generation vaccines are based on the use of DNA and a non-infectious particle known as an adenovirus. Because both vaccines are produced through genetic engineering techniques, they do not contain any live virus and cannot cause HIV infection. The HIV-1 gag DNA vaccine includes a man-made copy of one of the genes from HIV, which will make an immune response to the real HIV. The adenovirus serotype 5 HIV-1 vaccine also contains the same man-made copy of the HIV-1 gene but uses a defective, non-infectious respiratory virus (adenovirus) as a backbone. These test vaccines are designed to stimulate the immune system to develop an immune defense against the HIV proteins.
“The goal of this study is to evaluate the effect of these vaccines on the immune system’s ability to produce T-cell responses and antibodies against HIV-1,” said Thomas Evans, professor and chief of the Division of Infectious Diseases at UC Davis School of Medicine and Medical Center and principal investigator of the study. “A secondary goal is to assess whether aluminum phosphate, a common additive to vaccine formulas, improves the immune response.”
The trial is a “double-blind” study, with some participants receiving the test vaccines and some participants receiving a placebo, an inactive substance used as a comparison. Neither the volunteers nor the research staff will know which product is being administered. Participants receive the test vaccine by muscle injection.
Initial safety and tolerability studies of the HIV-1 gag DNA vaccine were done in animals and more than 30 healthy volunteers. These studies have shown the vaccine to be generally safe and well-tolerated. The most common symptoms reported have been injection site pain and headache. Merck is currently conducting another study in healthy volunteers using the adenovirus vaccine, which has been very safe to date. Information from this study is still being collected.
UC Davis researchers emphasize that this trial involves a test vaccine. They will not enroll anyone whose motive for participation is to use the vaccine as a reason to increase risky behaviors by counting on the vaccine to act as protection against HIV. “Participating in this trial is one way to make an important contribution to HIV vaccine research,” said Evans. It will take a sustained and probably lengthy effort to develop a vaccine that stops HIV in United States and around the world. This trial is an important step in reaching that goal.”
TO PARTICIPATE IN THE STUDY, volunteers must be healthy males or females between the ages of 18 and 50 who currently are HIV-negative and at low risk for acquiring HIV infection. Individuals who are pregnant or nursing, or who have hepatitis C or hepatitis B infection are not eligible for the study.
Study participants will visit UC Davis Medical Center 17 times over an 18-month period to receive a series of two vaccine injections. Blood and urine samples will be taken and other tests conducted at regular intervals. All volunteers will receive extensive counseling that will focus on reducing the chance of becoming exposed to HIV.
For more information about enrolling in this study, contact Susan Hulse, study coordinator, at (916) 734-8637.
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