NCT01687595

Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes

A Phase 2a, Multicenter, Double-blinded, Randomized, 2-Period Trial to Evaluate the Effect of HerpV Administered in Combination With the Stimulon® Adjuvant QS-21 on Viral Shedding in Adults With Recurrent Genital Herpes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.

Detailed description

This study will evaluate the biological effectiveness and safety of the HerpV vaccine in combination with adjuvant QS-21. The Safety and tolerability of HerpV plus QS-21 will also be evaluated by collecting number and severity of adverse events throughout the study. Participants will undergo a baseline/ screening period. This is a 45 day period when the participant collects a swab of the genital area each day. In case of a recurrence, participant will be required to collect two swabs a day. If the participant collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study. Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The participant will collect swabs of the genital region each day for 45 days. Participants who successfully complete Study Period 1 will proceed to Study Period 2. They will receive a booster injection of study drug or placebo according to their original randomization assignment. The participants will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.

Conditions

• Herpes Simplex Type 2

Interventions

Type	Name	Description
DRUG	HerpV and QS-21	HerpV (recombinant human heat shock protein 70 \[rh-Hsc70\] polyvalent peptide complex) in combination with adjuvant QS-21
DRUG	Placebo	phosphate buffered saline

Timeline

• Start date: 2012-10-29
• Primary completion: 2013-09-01
• Completion: 2015-01-01
• First posted: 2012-09-19
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

5 sites across 1 country: United States