Genocea closes patient enrollment in GEN-003 Phase II trial to treat genital herpes

Top-line data from the immediate post-vaccination observation period of the trial will be reported in late second quarter of 2015.

More than 300 patients from 17 institutions in the US were enrolled in the trial and they were randomized to one of six dosing groups of either 30 micrograms (mcg) or 60mcg per antigen paired with one of three adjuvant doses (25mcg, 50mcg, or 75mcg).

The trial’s primary endpoint is the change from baseline in viral shedding rate, a measure of anti-viral activity.

The Phase II dose optimization trial is also designed to assess the impact on genital lesion rates as well as immunogenicity and safety. The company said that patients will receive three doses of GEN-003 or placebo at 21-day intervals.

Genocea chief medical officer Seth Hetherington said: "The objective of this trial is to build upon the impressive results observed in the prior Phase I/IIa trial.

"Our goal is to replicate the results of the best performing vaccine dose in that trial, and test other combinations of proteins and adjuvant. By achieving these objectives we will identify and fully justify the best dose to take forward based on an optimal balance of safety and anti-viral activity.

"The patient response and rapid enrollment we experienced underscore the unmet medical need for new treatment options with novel mechanisms of action for this lifelong disease."

In the previous Phase I/IIa clinical trial, subjects in the 30mcg per antigen and 50mcg of adjuvant dose group experienced, at the immediate post-vaccination observation period, a 52% reduction in viral shedding rate compared to baseline.