Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity

Inclusion criteria

• Completion of Study GEN-003-002
• Receipt of at least 1 dose of GEN-003 (any dose combination) in Study GEN-003-002.
• Collection of at least 45 of 56 anogenital swabs during the Month 11 to 12 swab collection period in Study GEN-003-002.
• Willing and able to provide written informed consent.
• Willing to perform and comply with all study procedures, including attending clinic visits as scheduled.
• For each swab collection period, willing to not use HSV-2 antiviral therapy from 14 days before the swab collection period through the end of the period.

Exclusion criteria

• Any important protocol deviation in Study GEN-003-002.
• Use of HSV-2 antiviral therapy within 14 days before the beginning of Swab Collection Period 1.
• Use of topical steroids or antiviral medication in the anogenital region within 14 days before the beginning of Swab Collection Period 1.
• Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days before the beginning of Swab Collection Period 1.
• Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months before the Visit 1, any dose of corticosteroids within 30 days before Visit 1, or high-dose inhaled corticosteroids [>960 µg/day of beclomethasone diproprionate or equivalent]) or other immunosuppressive agents.
• Presence or history of autoimmune disease, regardless of current treatment.
• Receipt of a vaccine containing HSV-2 antigens other than GEN-003.
• Pregnant women.
• History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
• Onset of an AESI since Month 12 in study GEN-003-002.
• Other active, uncontrolled comorbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.