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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687595
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
Agenus Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Herpes Simplex Type II Drug: HerpV and QS-21 Drug: Placebo Phase 2

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Drug: Placebo
phosphate buffered saline.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Seropositive for HSV-2
  • Clinically active genital herpes defined as a history of 1-9 episodes per year for at least one year prior to screening or one year prior to beginning suppressive therapy.
  • Willing to either use an effective method of contraception or abstain from sexual intercourse throughout the 48 week study period.
  • If female of childbearing potential, have a negative serum pregnancy test.
  • Agree to not receive any other investigational drugs while enrolled in this study.
  • The above criteria must be met before subjects are allowed to enter the 45 day swabbing period to be screen for the study.
  • Completion of greater than or equal to 80% (36 days) of the 45 day consecutive daily genital swabs.

Exclusion Criteria:

  • Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the Principal Investigator, would prevent study completion.
  • A history of HSV infection of the eye (herpes simplex interstitial keratitis or uveitis), or herpes-associated erythema multiforme.
  • A history of immune suppression or autoimmune disorder.
  • Continued use of suppressive anti-viral therapy for HSV-2; a one week washout of any anti-viral therapy (suppressive and episodic) is required prior to initiating the swabbing period.
  • Concomitant use of systemic corticosteroids or immune-suppressive medications. The use of nasal steroids is acceptable.
  • HIV positive.
  • Presence of active Hepatitis B or C infection.
  • Known hypersensitivity or allergies to acyclovir or valacyclovir.
  • Pregnant or breast-feeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01687595

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United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Texas
Center for Clinical Studies - Texas Medical Center
Houston, Texas, United States, 77030
Center for Clinical Studies - Cypress
Houston, Texas, United States, 77065
Center for Clinical Studies- Webster
Houston, Texas, United States, 77598
United States, Washington
University of Washington Virology Research Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Agenus Inc.
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Study Director: Agenus Medical Monitor Agenus Inc.
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Responsible Party: Agenus Inc. Identifier: NCT01687595    
Other Study ID Numbers: C-400-02
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Agenus Inc.:
herpes simplex virus type 2,
genital herpes
Additional relevant MeSH terms:
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Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases