Dr. Gulley on the Adverse Event Profile for PROSTVAC

James L. Gulley, MD, PhD, Head, Clinical Trials Group, Deputy Laboratory Chief, National Cancer Institute (NCI), gives an overview of the adverse event profile for PROSTVAC.

PROSTVAC is an immunotherapeutic vaccine for men with castration-resistant prostate cancer. The adverse event profile for PROSTVAC was just updated for all trials by the NCI, Gulley says. The analysis found that the majority of patients experienced few side effects.

The most common side effect was an injection site reaction: redness or a bump where the injection was given. This type of side effect is clinically insignificant, Gulley says. Some patients, about 5-10%, experienced mild to moderate flu-like symptoms, which is indicative of a strong immune response.