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

NCT01687595 | Completed Phase 2 Results DMC

• 1 other identifier: C-400-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Herpes Simplex Type 2

Keywords

herpes simplex virus type 2,; genital herpes

Outcome Measures

Primary Outcomes (2)

• Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 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.

  Baseline, Weeks 6-13

• Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 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.

  Baseline, Weeks 26-33

Other Outcomes (2)

• Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time

  Baseline through Week 26

• Number of Participants With CD8+ Immune Response at Any Time

  Baseline through Week 26

Study Arms (2)

HerpV 240 μg + QS-21 50 μg

EXPERIMENTAL

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.

Drug: HerpV and QS-21

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

HerpV and QS-21 DRUG

HerpV (recombinant human heat shock protein 70 \[rh-Hsc70\] polyvalent peptide complex) in combination with adjuvant QS-21

Also known as: AG-707

HerpV 240 μg + QS-21 50 μg

Placebo DRUG

phosphate buffered saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agenus Inc.: lead

Study Sites (5)

Westover Heights Clinic

Portland, Oregon, 97210, United States

Location

Center for Clinical Studies - Texas Medical Center

Houston, Texas, 77030, United States

Location

Center for Clinical Studies - Cypress

Houston, Texas, 77065, United States

Location

Center for Clinical Studies- Webster

Houston, Texas, 77598, United States

Location

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 21945262 BACKGROUND

MeSH Terms

Conditions

Herpes Genitalis

Interventions

saponin QA-21V1

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Results Point of Contact

• Title: Agenus, Inc. Clinical Trial Information
• Organization: Agenus Inc.

clinicaltrialinfo@Agenusbio.com

781-674-4265

Study Officials

• Agenus Medical Monitor

  Agenus Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 19, 2012
• Study Start: October 29, 2012
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2015
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Locations

US (5)