The Botswana-Harvard Partnership has discontinued vaccinations in the Phase I HIV Vaccine Trial known as HVTN 059, announced Joseph Makhema, the program's director.
Makhema said that a warning letter from the U.S. FDA was issued to the manufacturers of the vaccine, AVX101, due to "documentation irregularities." The health and safety profile of the vaccine was not involved in the warning. The U.S. National Institute of Health's Division of Acquired Immunodeficiency Syndrome (DAIDS), which funded the trial, ordered an audit to review issues raised in the FDA warning letter, and the trial was halted.
Vaccine sites were notified of the decision to discontinue in December 2005. The study began enrolling HIV negative volunteers in the United States on October 2004 and in Botswana and South Africa in May 2005. The manufacturer's name was not disclosed.
