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

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ClinicalTrials.gov Identifier: NCT01687595
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date January 26, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01687595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Subjects With Recurrent Genital Herpes
Official Title  ICMJE A Phase 2a Multicenter, Double-blinded, Randomized Trial to Evaluate The Effect of HerpV on Viral Shedding in Adults With Recurrent Genital Herpes
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Herpes Simplex Type II
Intervention  ICMJE
  • Drug: HerpV and QS-21
    HerpV (formerly AG-707 rh-Hsc70 Polyvalent Peptide Complex) in combination with adjuvant QS-21.
    Other Name: AG-707
  • Drug: Placebo
    phosphate buffered saline.
Study Arms  ICMJE
  • Experimental: HerpV and QS-21
    HerpV and QS-21
    Intervention: Drug: HerpV and QS-21
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Wald A, Koelle DM, Fife K, Warren T, Leclair K, Chicz RM, Monks S, Levey DL, Musselli C, Srivastava PK. Safety and immunogenicity of long HSV-2 peptides complexed with rhHsc70 in HSV-2 seropositive persons. Vaccine. 2011 Nov 3;29(47):8520-9. doi: 10.1016/j.vaccine.2011.09.046. Epub 2011 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2015)
80
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
75
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687595
Other Study ID Numbers  ICMJE C-400-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agenus Inc.
Study Sponsor  ICMJE Agenus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Agenus Medical Monitor Agenus Inc.
PRS Account Agenus Inc.
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP