New Clinical Alert Issued by National Institute of Allergy and Infectious Diseases (NIAID)

The National Institute of Allergy and Infectious Diseases (NIAID), issued a new Clinical Alert on September 21, 2007:

• 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 — also referred to as the HVTN 502 or Merck V520-023 study. The clinical trial, which began enrolling volunteers in December 2004, is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the pharmaceutical company Merck & Co. Inc., which also developed and supplied the candidate vaccine. 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 (the vaccine itself cannot cause HIV infection because it contains only synthetically produced snippets of viral material). 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.

Links to Clinical Alerts/Advisories can also be found from these NLM Web sites:

• A complete list of all Clinical Alerts is available from the NIH Clinical Alerts and Advisories page on the NLM Web site.
• MedlinePlus® features Clinical Alerts/Advisories as NIH Press Releases on the appropriate Health Topics page(s).
• PubMed®, the NLM Gateway and ClinicalTrials.gov each have access points to the Clinical Alerts.