BETHESDA, Maryland—Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) have begun enrolling 21 volunteers in a phase I trial of a new plasmid DNA-based HIV vaccine (VRC4302). The randomized, controlled, double-blinded, dose-escalation study will examine the vaccine’s toxicity, dose, and immune response. It will be conducted on the National Institutes of Health campus.
The 21 healthy men and women admitted to the study will be HIV negative and at low risk of becoming infected. They will be between 18 and 60 years old and randomized to receive either the experimental vaccine or a placebo.
The volunteers will be divided into three groups of seven members each; five volunteers in each group will receive the vaccine by intramuscular injection and two will get placebo.
Dose Escalation
The first group in the stepwise trial will receive 0.5 mg of the vaccine. The second group will receive 1.5 mg, and the third will get 4 mg. Each participant will receive three injections of either vaccine or placebo, each 28 days apart. Groups 2 and 3 will not receive their injections if the previous group suffered any significant toxicity.
The volunteers will be observed for at least 1 year after their first injection, and will be followed for another 3 years with once- or twice-a-year contacts by the study staff.
The HIV vaccine is one of several in the testing pipeline. It is meant to stimulate cellular immunity against the AIDS-causing virus.
