Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Genital Herpes, HSV-2 Infection

In brief

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.

Key facts

Study ID

NCT03146403

Run by

Genocea Biosciences, Inc.

People needed

33

Starts

2017-05-24

Expected to finish

2018-06-11

Last updated by the study team

2019-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Optimus Medical Group — San Francisco, California, United States
• UNC Health — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• NW Dermatology and Research Clinic — Portland, Oregon, United States
• Tekton Research — Austin, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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