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

A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection

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.

This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo.

Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms.

GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.

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