Clinical Trials

The results of the breakthrough clinical trial have been described in a peer-reviewed journal, Cutis. The abstract appears below.

Casanova G, Cancela R, Alonzo L, Benuto R, del Carmen Magana M, Hurley DP, Fishbein E, Lara C, Gonzalez T, Ponce R, Burnett JW, Calton GJ. A double-blind study of the efficacy and safety of the ICP10)PK vaccine against recurrent genital HSV-2 infections. Cutis. 2002;70(4):235-239.

A randomized double-blind trial to evaluate the safety of a novel recombinant virus, ICP10)PK, for reduction or prevention of recurrent herpes simplex virus type 2 (HSV-2) infection was carried out in public hospitals in Mexico City. Persons having a minimum of 5 documented herpetic recurrences in the previous year were randomized for vaccination. Patients were examined within 72 hours of lesion occurrence. If accepted into the study, the patient was inoculated subcutaneously in the upper deltoid muscle area at days 7, 17, and 28 after initiation of lesion occurrence. Recurrences were recorded by patient diary and physician examination.