Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
Condition: Genital Herpes; HSV-2 Infection
MeSH terms: Infections; Communicable Diseases; Herpes Simplex; Herpesviridae Infections; Herpes Genitalis
Intervention: GEN-003; Matrix-M2; 0.9% normal saline
Intervention description: HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; Placebo
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Healthy volunteers: No
Keywords: HSV; Herpes; Genital Herpes; Vaccine

Summary:

      The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces
      the number of days that subjects have a genital herpes recurrence. The second purpose of the
      study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Study GEN-003-003

          -  Received all 3 GEN-003 doses (any dose combination) in Study GEN-003-003

          -  Received last dose of GEN-003 within 11 to 18 months prior

          -  Reported data in the daily electronic reporting period on at least 80% of days in
             Study GEN-003-003

          -  Collected at least 45 swabs (of 56 total expected swabs) during the Month 11 to 12
             swab collection period in Study GEN-003-003

          -  Willing and able to provide written informed consent

          -  Willing to perform and comply with all study procedures

          -  Postmenopausal or willing to practice a highly effective method of contraception for
             28 days before and 90 days after enrollment

        Exclusion Criteria:

          -  Did not meet all eligibility criteria in Study GEN-003-003, or received incorrect
             treatment in Study GEN-003-003

          -  Use of suppressive antiviral medication within 14 days prior

          -  Use of topical steroids or antiviral medication in the anogenital region within 14
             days prior

          -  Use of tenofovir, lysine, or other medication or supplement known or purported to
             affect HSV recurrence frequency or intensity within 14 days prior

          -  History of any form of ocular HSV infection, HSV-related erythema multiforme, or
             herpes meningitis or encephalitis

          -  Immunocompromised individuals

          -  Diagnosis or suspicion of an AESI

          -  Diagnosis or suspicion of any other autoimmune disease not listed in Appendix 4 of the
             protocol

          -  Vaccine-related SAE in GEN-003-003

          -  Known current infection with HIV or hepatitis B or C virus

          -  History of hypersensitivity to any component of the vaccine

          -  Prior receipt of another vaccine containing HSV-2 antigens other than GEN-003

          -  Receipt of any IP within 30 days prior to the maintenance dose of GEN-003/placebo

          -  Receipt of any blood product within 90 days prior to the maintenance dose

          -  Receipt of a live vaccine within 28 days prior to or any other vaccine within 14 days
             prior to maintenance dose

          -  Planned use of any vaccine from the maintenance dose to 28 days after the maintenance
             dose

          -  Pregnant or nursing women

          -  History of drug or alcohol abuse

          -  Other active, uncontrolled comorbidities

          -  Changes to medication used to manage an underlying comorbidity within 60 days prior