Clinical trial NCT01687595: Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Simplex Type 2
Keywords: herpes simplex virus type 2,
genital herpes
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)
timeFrame: Baseline, Weeks 6-13
measure: Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)
timeFrame: Baseline, Weeks 26-33
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time
timeFrame: Baseline through Week 26
measure: Number of Participants With CD8+ Immune Response at Any Time
timeFrame: Baseline through Week 26
Locations:
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Houston
country: United States
facility: Center for Clinical Studies - Texas Medical Center
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Cypress
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies- Webster
state: Texas
city: Seattle
country: United States
facility: University of Washington Virology Research Clinic
state: Washington
Study officials:
affiliation: Agenus Inc.
name: Agenus Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.