Evaluating New Formulation of Therapeutic HSV-2 Vaccine

Genital Herpes Simplex Type 2 Clinical Trial

Official title:

A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515175
• Other study ID #: GEN-003-003
• Status: Completed
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2018
• Source: Genocea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: May 25, 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Herpes Simplex Type 2
• Herpes Genitalis
• Herpes Simplex

Intervention

Biological:
• Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
• GEN-003
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

Drug:
• Placebo
0.9% Normal Saline

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	University of Alabama-Birmingham	Birmingham	Alabama
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	Medical Center for Clinical Research	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genocea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HSV-2 viral shedding rate		baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary	Immunogenicity measured by humoral (antibody) responses to vaccine antigens		13 weeks
Secondary	Impact on clinical HSV-2 disease based on time to first recurrence		64 weeks
Secondary	Number of patients with adverse events as a measure of safety and tolerability		64 weeks
Secondary	Reduction in HSV-2 viral shedding rate		After vaccination (6 Months and 12 Months)
Secondary	Impact on clinical HSV-2 disease based on lesion rate		64 weeks
Secondary	Impact on clinical HSV-2 disease based on percent recurrence-free		64 weeks