Phase 2
N=80
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
Herpes Simplex Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01687595 ↗Enrolled (actual)
80
Serious AEs
3.8%
Results posted
Jul 2021
Primary outcome: Primary: Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) — 13.53 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HerpV and QS-21 (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Agenus Inc.
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13) |
13.53 | — |
| PRIMARY Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33) |
12.78 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01687595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.