maintenance dose study of gen-003 in subjects with genital herpes infection

Conditions: Genital Herpes; HSV-2 Infection

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.

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.

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

Keywords: hsv herpes genital herpes vaccine