Genital Herpes (HSV-2) Therapeutic Vaccine Trial (Genocea GEN-003)

The University of Washington is seeking volunteers for a Phase 2 genital herpes (HSV-2) vaccine study.  The purpose of this research study is to test an investigational herpes vaccine.  Investigational means the vaccine is not approved by the FDA.  The study will test different vaccine dose combinations to see which dose best reduces the amount of HSV-2 in the genital area. 

Participants will be assigned by chance (like flipping a coin) to 1 or 2 different dose combinations of the vaccine or placebo.  Participants will receive 3 vaccinations, 21 days apart.  Follow-up visits will involve physical exams and blood draws.  Participants will also be asked to collect genital swabs for 28-days twice during the study: before the first vaccine dose (baseline) and again after the third (final) dose.  The study will last for a little over one year and involve at least 12 clinic visits plus a monthly phone calls.    

To be eligible for the study you must: 

  1. Be between the ages of 18-50
  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
  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. Have any known impairment of the immune system                                                                                              
  2. Have hepatitis B or C, or HIV infection
  3. Pregnant or breast-feeding (women only)

Other Information:

  • Vaccine days will require that you remain at the clinic for 3-4 hours.
  • If you are currently taking HSV suppressive therapy, you will be asked to stop taking this medication 14 days prior to starting the study and remain off the medication for the first 4 months of the study. 
  • You must be willing to not treat genital your herpes outbreaks during the two 28-day swabbing periods.
  • You will be compensated $1750 for the entire study.       


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