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Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants 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.
 
ClinicalTrials.gov Identifier: NCT01687595
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 19, 2012
Results First Submitted Date  ICMJE May 26, 2021
Results First Posted Date  ICMJE July 13, 2021
Last Update Posted Date July 13, 2021
Actual Study Start Date  ICMJE October 29, 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2021)
  • Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) [ Time Frame: Baseline, Weeks 6-13 ]
    The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
  • Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) [ Time Frame: Baseline, Weeks 26-33 ]
    The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 22, 2021)
  • Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time [ Time Frame: Baseline through Week 26 ]
  • Number of Participants With CD8+ Immune Response at Any Time [ Time Frame: Baseline through Week 26 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Official Title  ICMJE 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
Brief 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.

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 2
Intervention  ICMJE
  • Drug: HerpV and QS-21
    HerpV (recombinant human heat shock protein 70 [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 240 μg + QS-21 50 μg
    Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week.
    Intervention: Drug: HerpV and QS-21
  • Placebo Comparator: Placebo
    Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week.
    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 herpes simplex virus type 2 (HSV-2)
  • Clinically active genital herpes defined as a history of 1-9 episodes per year for at least 1 year prior to screening or 1 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 participants are allowed to enter the 45-day swabbing period to be screen for the study.
  • Completion and collection 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 herpes simplex virus (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 1 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.
  • Human immunodeficiency virus (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
Plan to Share IPD: Undecided
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 June 2021

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