Evaluating New Formulation of Therapeutic HSV-2 Vaccine (NCT02515175) | Clinical Trial Compass
CompletedPhase 2
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
United States131 participantsStarted 2015-11
Plain-language summary
This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria
* A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
* Diagnosis of genital HSV-2 infection for \> 1 year
* Willing and able to provide written informed consent
* Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
* Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
* Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug
Exclusion Criteria
* On suppressive antiviral therapy within 14 days of starting the study
* Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
* Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within …
What they're measuring
1
Change in HSV-2 viral shedding rate
Timeframe: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)