Clinical Trials Resource Center

Herpes Simplex Infections

June 8, 2015

Genocea Biosciences issued results of a phase II study of GEN-003 for the treatment of genital herpes. The study enrolled 310 subjects who were randomized to one of six dosing groups of either 30µg or 60µg per protein paired with one of three adjuvant doses (25µg, 50µg or 75µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. This 28-day observation period was repeated immediately after the completion of dosing and will be repeated two more times over the course of this trial, at six and 12 months following dosing. During the 28-day observation period, the best dose of 60µg per protein/75µg of Matrix-M2 adjuvant demonstrated a highly statistically significant (p<0.0001) 55% reduction from baseline in the viral shedding rate, the primary endpoint of the trial and a measure of anti-viral activity. All dose combinations tested, including the successful 30µg per protein/50µg of adjuvant dose from the prior phase I/IIa trial, demonstrated a statistically significant viral shedding rate reduction v. baseline and only the lowest dose combination did not demonstrate a statistically significant reduction v. placebo. The phase II study showed that GEN-003 was generally safe and well-tolerated by patients, with no serious adverse events related to the vaccine.

July 21, 2014

Agenus issued results of a phase II study of HerpV for treatment of genital Herpes Simplex Virus-2 (HSV-2). The randomized, double-blind, multi-center study enrolled 80 subjects with a history of one to nine herpes recurrences within the prior 12 months. 70 subjects received the active treatment, HerpV and QS-21 Stimulon, and 10 subjects received placebo. Three injections of HerpV at a dose of 240μg (includes12μg of a mix of 32 different HSV-2 antigenic peptides) or placebo were given at two week intervals. HSV-2 activity in the genito-urinary tract was monitored by PCR for HSV-2 DNA in genital swabs for 45 days before and after the initial course of three vaccinations. The primary analysis, which looked at viral shedding after the initial three HerpV vaccinations, demonstrated that subjects who received HerpV had a statistically significant reduction in viral shedding (P=0.015; RR=0.85). The results also demonstrate a reduction in viral load of 34% (P=0.08). Placebo patients showed no reduction compared to baseline in either parameter. More than half of those vaccinated developed a robust anti-HSV cytotoxic T-cell immune response, and in those patients there was a statistically significant 75% reduction in viral load (P<0.001; CI: 46.2—88.6%). After the booster shot, HerpV demonstrated a durable reduction in viral shedding approximating 14% (RR=0.86 and CIs: 0.58-1.26) and remains consistent with the reduction in viral shedding observed duing the initial treatment period.

December 3, 2007

Transport reported positive results from a phase II trial of SoloVir for the treatment of Herpes labialis. This randomized, double blind, placebo-controlled trial, dubbed TPI-H-221, enrolled two hundred and sixty subjects. The subjects were randomized in a 1:1:1 ratio into one of three treatment groups: treatment with SoloVir gel followed by treatment with placebo gel; treatment with placebo gel followed by treatment with SoloVir gel; or treatment with placebo gel followed by treatment with placebo gel. Treatment was self administered at the first signs and symptoms of a herpatic lesion. The treatment phase ended after eighty subjects in each group had herpatic recurrence and received treatment. Data indicated that treatment at this early stage resulted in a statistically significant effect on the herpetic episode. The SoloVir treated groups showed a 79% increase in aborted lesions over placebo (43% active; 24% placebo; p= 0.03). The subjects receiving SoloVir also experienced a 3.5 day reduction in time to complete healing (p= 0.015). Treatment was well tolerated, with no reported serious adverse events. Based on the results, Transport plans to initiate the next stage of development in 2008.

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