Clinical trial NCT02515175: Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Official title: A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Genital Herpes Simplex Type 2
Keywords: HSV
Herpes
Genital Herpes
Vaccine
Lead sponsor: Genocea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.

Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Change in HSV-2 viral shedding rate
timeFrame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary outcomes:
measure: Immunogenicity measured by humoral (antibody) responses to vaccine antigens
timeFrame: 13 weeks
measure: Impact on clinical HSV-2 disease based on time to first recurrence
timeFrame: 64 weeks
measure: Number of patients with adverse events as a measure of safety and tolerability
timeFrame: 64 weeks
measure: Reduction in HSV-2 viral shedding rate
timeFrame: After vaccination (6 Months and 12 Months)
measure: Impact on clinical HSV-2 disease based on lesion rate
timeFrame: 64 weeks
measure: Impact on clinical HSV-2 disease based on percent recurrence-free
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital
state: Ohio
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
citation: Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.