Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genita… (NCT01687595) | Clinical Trial Compass
CompletedPhase 2
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
United States80 participantsStarted 2012-10-29
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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 …
What they're measuring
1
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
2
Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)