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

Completed

Conditions studied: Genital Herpes Simplex Type 2

In brief

This study is a follow-up study from Study GEN-003-002 to evaluate long-term efficacy and immunogenicity of GEN-003 in subjects with genital HSV-2 infection.

Key facts

Study ID

NCT02910284

Run by

Genocea Biosciences, Inc.

People needed

140

Starts

2016-09-16

Expected to finish

2017-07-14

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Illinois - Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• The Fenway Institute — Boston, Massachusetts, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• NW Dermatology and Research — Portland, Oregon, United States
• Magee - Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Tekton Research — Austin, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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