The primary objective of the three-arm phase I clinical trial is to determine the safety and tolerability of different dosages and routes of administration of the DNA vaccine, and a fixed dosage and route of administration of an HIV protein boost.
The vaccine strategy is to assess in human volunteers whether a DNA vaccine with a protein boost can stimulate both antibody and T-cell immune responses to the virus as previously demonstrated in animal models.
“We reached this significant recruitment milestone six months ahead of our internal timetable” stated Steven Kriegsman, president and CEO of CytRx. “We had previously announced that dosing would be completed by the end of 2005. Based on clinical investigators’ efforts at the University of Massachusetts Medical School (UMMS) to quickly complete enrollment, we now expect dosing to be completed by the end of July 2005, six months ahead of schedule.”
CytRx, Advanced BioScience Laboratories (ABL) and UMMS anticipate that preliminary safety, tolerability and limited immunogenicity data from this trial will be presented by the clinical investigators later this year.
“It is our hope that the results from this clinical trial will provide useful information regarding the immune response to this DNA vaccination as well as the effect of using protein as a vaccine boost,” said Dr Jeff Kennedy, assistant professor of medicine at UMMS and the principal investigator of the clinical trial.