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

NCT ID: NCT01687595

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-29
• Study Completion Date: 2015-01-31

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.

Conditions

Herpes Simplex Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

HerpV and QS-21

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

phosphate buffered saline

Interventions

HerpV and QS-21

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

Intervention Type: DRUG

Placebo

phosphate buffered saline

Intervention Type: DRUG

Other Intervention Names

AG-707

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agenus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agenus Medical Monitor

Role: STUDY_DIRECTOR

Agenus Inc.

Locations

Westover Heights Clinic

Portland, Oregon, United States

Center for Clinical Studies - Texas Medical Center

Houston, Texas, United States

Center for Clinical Studies - Cypress

Houston, Texas, United States

Center for Clinical Studies- Webster

Houston, Texas, United States

University of Washington Virology Research Clinic

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21945262 (View on PubMed)

Other Identifiers

C-400-02

Identifier Type: -

Identifier Source: org_study_id