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Study Title

A Randomized, Double‐Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN‐003 and Matrix‐M2 in Subjects with Genital HSV‐2 Infection

Principal Investigator

Anna Wald, MD, MPH

Study Description

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. The study will also evaluate how a person’s immune system is affected by the vaccine and how safe the vaccine is.

This study is what is known as a randomized clinical trial. Randomization means that participants are put into a group by chance, like flipping a coin. Participants will be randomized to one of six combinations of the study vaccine or placebo. Participants assigned to the placebo group will be eligible to participate in another study, similar to this, where they will be randomized into one of the 6 study vaccine dose groups.

Participants will receive 3 vaccinations, 21 days apart. Vaccination visits will last 3‐4 hours. Follow‐up visits will involve physical exams and blood draws. Participants will also be asked to collect genital swabs for 28‐days at 4 times during the study: before the first vaccine dose (baseline), after the third (final) dose, and then again 6 months and at one year after the last dose. The study will last for a little over one year (14 months) and involve at least 15 clinic visits plus a few phone calls.

Participants must be willing to stop taking HSV suppressive therapy 7 days prior to starting of study and remain off the medication (suppressive or episodic) for the first 4 months of the study and again for one month mid‐way through the study and one month at the end of the study.

Eligibility Criteria:

1. Men and women between the ages of 18‐50
2. History of genital herpes (HSV‐2) outbreaks
3. In good health
4. Must be willing to use an effective form of birth control for the entire study period

Exclusions (conditions which would prevent a volunteer from participating in this study):

1. Have ever been diagnosed with genital HSV‐1 infection.
2. History of any form of HSV infection of the eye, HSV‐related erythema multiforme, or herpes meningitis or encephalitis.
3. Have any known impairment of the immune system
4. Have hepatitis B or C, or HIV infection
5. Pregnant or breast‐feeding (women only)
6. If currently taking HSV suppressive therapy, willing to stop taking therapy during the study.

Location:

UW Virology Research Clinic
908 Jefferson St,
11^th Floor Seattle,
WA 98104