Clinical Alert: Immunizations Are Discontinued in Two HIV Vaccine Trials
An independent Data and Safety Monitoring Board (DSMB) met this week to review interim data from a large, international HIV vaccine clinical trial known as the STEP study. The clinical trial is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), and the pharmaceutical company Merck & Co. Inc. Based on a review of interim data, the DSMB concluded that the vaccine cannot be shown in this trial to prevent HIV infection or affect the course of the disease in those who become infected with HIV. Therefore, Merck and NIAID instructed all study sites to cease administering the investigational vaccine but continue scheduled follow-up visits with all volunteers until the data can be more thoroughly evaluated and a course of action is developed. For the entire clinical alert, visit: http://www.nlm.nih.gov/databases/alerts/hiv_step_study.html.
