Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT03146403
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03146403
Study Brief:
Protocol Section:
NCT03146403