Evaluating New Formulation of Therapeutic HSV-2 Vaccine

May 21, 2018 updated by: Genocea Biosciences, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama-Birmingham
    • California
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • The Fenway Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GEN-003 60ug / Matrix-M2 50ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
Biological: Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • Adjuvant
Biological: 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
Other Names:
  • HSV Therapeutic Vaccine
Experimental: GEN-003 60ug / Matrix-M2 75ug
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
Biological: Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
  • Adjuvant
Biological: 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
Other Names:
  • HSV Therapeutic Vaccine
Placebo Comparator: Placebo
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
Drug: Placebo
0.9% Normal Saline
Other Names:
  • 0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HSV-2 viral shedding rate
Time Frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Time Frame: 13 weeks
13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence
Time Frame: 64 weeks
64 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: 64 weeks
64 weeks
Reduction in HSV-2 viral shedding rate
Time Frame: After vaccination (6 Months and 12 Months)
After vaccination (6 Months and 12 Months)
Impact on clinical HSV-2 disease based on lesion rate
Time Frame: 64 weeks
64 weeks
Impact on clinical HSV-2 disease based on percent recurrence-free
Time Frame: 64 weeks
64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genocea Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-003-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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