Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Subjects With Recurrent Genital Herpes
The purpose of this study is to evaluate the effect the HerpV vaccine has on recurring episodes of genital herpes by evaluating viral shedding before, after treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2a Multicenter, Double-blinded, Randomized Trial to Evaluate The Effect of HerpV on Viral Shedding in Adults With Recurrent Genital Herpes|
- To evaluate the effect of HerpV administration on HSV-2 mucocutaneous shedding as measured by the shedding rate after the treatment period as compared to the baseline swabbing period. [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: HerpV and QS-21
HerpV and QS-21
Drug: HerpV and QS-21
HerpV (formerly AG-707 rh-Hsc70 Polyvalent Peptide Complex) in combination with adjuvant QS-21.
Other Name: AG-707
|Placebo Comparator: Placebo||
phosphate buffered saline.
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.
Biological effectiveness will be evaluated by comparing the viral shedding rate during the treatment period as compared to the baseline period of the study.
Subjects will undergo a baseline/ screening period. This is a 45 day period when the subject collects a swab of the genital area each day. . In case of a recurrence, subjects will be required to collect two swabs a day. If the subject collects at least 80% of the swabbing samples and meets all eligibility criteria they may enroll in the study.
Subjects who meet all inclusion and no exclusion criteria will be enrolled and randomized in Study Period 1 (treatment period). In order to assure the trial enrolls a good representation of women and men, a prespecified cap on women will be set at 50 (approximately 67% of the total enrolled population.)
Study Period 1 consists of three treatments and a 45 day swabbing period after the last treatment. The subject will collect swabs of the genital region each day for 45 days.
Subjects 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 orginal randomization assignment. The subjects will again enter a 45 day swabbing period, collecting swabs of the genital area each day for 45 days.
To evaluate immunologic response subjects will be required to have blood drawn at various time points through out the study.
Subjects will be required to suspend suppressive antiviral therapy for the duration of the study (up to week 48).
For one week before and during each 45 day swabbing period subjects will also be required to suspend episodic antiviral therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687595
|United States, Oregon|
|Westover Heights Clinic|
|Portland, Oregon, United States, 97210|
|United States, Texas|
|Center for Clinical Studies - Cypress|
|Houston, Texas, United States, 77065|
|Center for Clinical Studies - Texas Medical Center|
|Houston, Texas, United States, 77030|
|Center for Clinical Studies- Webster|
|Houston, Texas, United States, 77598|
|United States, Washington|
|University of Washington Virology Research Clinic|
|Seattle, Washington, United States, 98104|
|Study Director:||Agenus Medical Monitor||Agenus, Inc.|