Evaluating New Formulation of Therapeutic HSV-2 Vaccine

Completed · Phase 2 · Has a placebo group

Conditions studied: Genital Herpes Simplex Type 2

In brief

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

Key facts

Study ID

NCT02515175

Run by

Genocea Biosciences, Inc.

People needed

131

Starts

2015-11-01

Expected to finish

2017-05-25

Last updated by the study team

2018-05-22

Who can join

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

You may qualify if…

• A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy
• Diagnosis of genital HSV-2 infection for > 1 year
• Willing and able to provide written informed consent
• Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form
• Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study
• Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug

You may not qualify if…

• On suppressive antiviral therapy within 14 days of starting the study
• Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study
• Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study
• History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis
• Immunocompromised individuals
• Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents
• Presence or history of autoimmune disease regardless of current treatment
• Current infection with HIV or hepatitis B or C virus
• History of hypersensitivity to any component of the vaccine
• Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens
• Receipt of any investigational product within 30 days prior to Dose 1
• Receipt of blood products within 90 days prior to Dose 1
• Planned use of any vaccine over the course of the study
• Pregnant or nursing women
• History of drug or alcohol abuse
• Other active, uncontrolled comorbidities

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
• The Fenway Institute — Boston, Massachusetts, United States
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Childrens Hospital — Cincinnati, Ohio, United States
• Tekton Research — Austin, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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