Genital Herpes (HSV-2) Vaccine Study (Sanofi HSV529)

The University of Washington is seeking volunteers for a Phase 1 genital herpes (HSV-2) vaccine study.  The purpose of this study is to test whether HSV529, an experimental herpes vaccine, increases the amount and type of immune system cells that come to your skin when you have a genital herpes outbreak.   The study will also test to see whether HSV529 is safe.

The study will last for 1-2 years and involve at least 11 clinic visits plus phone calls.  After the first Screening Visit, participants will be followed for up to 2 years until their next genital herpes outbreak.   At their next outbreak, participants will take an FDA-approved herpes medication (valacyclovir) daily for 4 weeks.  After this 4-week period, participants will receive their first dose of the study vaccine.  The remaining 2 doses will occur at 1 month and 6 months after the first dose.   Study visits will involve blood draws, vaccinations, and genital skin and genital HSV lesion biopsies. Participants will be asked to collect daily genital swab samples for multiple 30-day periods during the study.

 

To be eligible for the study you must:

  1. Be between the ages of 18-55
  2. Have a history of genital herpes (HSV-2) outbreaks
  3. Be in good health
  4. Agree to practice birth control for the entire study period (women only)
  5. Be planning to live in the Seattle area for the next 1-2 years

 

Conditions which would prevent you from participating in this study:  

  1. Any impairment of the immune system                                                                                                                       
  2. Hepatitis B or C, or HIV infection
  3. Currently pregnant or breastfeeding (women only)

 

Other Information:

  • Vaccine days will require that you remain at the clinic for 4 hours.
  • A minimum of 14 genital biopsies (16 maximum) and 4 arm control biopsies will be collected during this study.
  • If you are currently taking HSV suppressive therapy, you will be asked to stop taking this medication during the study.
  • You must be willing to not treat genital your herpes outbreaks at certain times during the study.
  • You will be compensated $1825-$1950 for the entire study. 


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