This is a Phase I trial to evaluate the safety and immunogenicity of 2 doses of 3 candidate AIDS vaccines in asymptomatic HIV+ children >1 month to 12 years of age. Patients were randomized to vaccine (HIV gp 160 & gp 120) or their adjuvants in one of three treatment arms. This study closed to accrual for children in April, 1994. Patients who were enrolled at the time of closure continued to receive booster immunizations as outlined in the protocol and were followed until they reached their final scheduled study visit. In December 1994 the Genetech adult therapeutic vaccine trial was closed. The Genentech vaccine was the same vaccine used in one arm of ACTG 218 (Genetech MN gp120). To summarize the results of the Genentech-sponsored therapeutic trial, 573 adults with CD4 counts greater than or equal to 600 were immunized with 600 mcg of MN gp120 once a month for the first six months, and then once every other month. The planned duration of the study was three years. At 15 months, the Genentech Data Safety and Monitoring Board voted to terminate the study based on no effect seen in vaccine vs placebo as measured by CD4 decline, change in viral burden, and minor clinical endpoints. It was not believed that the termination of the Genentech trial would have an impact on the completion of ACTG 218, but this information was shared with patients participating in the trial.
Showing the most recent 10 out of 396 publications
