Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

May 30, 2018 updated by: Genocea Biosciences, Inc.

A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection

Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:

  1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)
  2. GEN-003: Antigens alone
  3. Placebo (DPBS diluent)

Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows:

  • 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)
  • Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)

Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2
  • Phase 1

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, 35294-0006
        • University of Alabama Vaccine Research Unit
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Infectious Disease Research
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Westover Heights Clinic
    • Texas
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies - Houston
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies - Clear Lake/Webster
    • Washington
      • Seattle, Washington, United States, 98104
        • UW Virology Research Clinic

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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women ages 18 to 50 years, inclusive.
  • Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom.

  • Diagnosis of genital HSV-2 infection for > 1 year supported by ONE of the following documented in the medical history or performed at screening:

    • Western blot for HSV-2
    • Type-specific polymerase chain reaction (PCR) or viral culture
    • Compatible clinical history AND HSV-2 ELISA (HerpSelect) index value >3.5
  • A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation suppressive therapy.
  • Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator.
  • Patient has provided written informed consent.
  • Ability and willingness to perform and comply with all study procedures including attending clinic visits as scheduled. Note: patients must provide, by the day of randomization, a minimum of 28 (equivalent of 14 days) baseline viral swab samples to continue to be eligible and be randomized).

Exclusion Criteria:

  • On suppressive antiviral medication within 7 days of baseline viral shedding evaluation.
  • Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents.
  • Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV).
  • Active lesions consistent with herpetic disease at the time of scheduled immunization.
  • Pregnant or nursing women.
  • Receipt of any investigational drug within 30 days of the first scheduled day of immunization.
  • History of hypersensitivity to any component of the vaccine.
  • History of genital HSV-1 infection.
  • History of: (1) any form of ocular HSV infection, (2) HSV-related erythema multiforme, or (3) herpes meningitis or encephalitis.
  • Any other condition which in the opinion of the Investigator would interfere with the successful completion of the study protocol.
  • 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.
  • Prior immunization with a vaccine containing HSV-2 antigens.
  • Receipt of blood products within 90 days of the first immunization.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose GEN-003 with Matrix M-2
10µg GEN-003, 50µg Matrix M-2 Adjuvant
Biological: GEN-003 with Matrix M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: Mid Dose GEN-003 with Matrix M-2
30µg GEN-003, 50µg Matrix M-2 Adjuvant
Biological: GEN-003 with Matrix M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: High Dose GEN-003 with Matrix M-2
100µg GEN-003, 50µg Matrix M-2 Adjuvant
Biological: GEN-003 with Matrix M-2
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Experimental: Low Dose GEN-003 Only
10µg GEN-003
Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Experimental: Mid Dose GEN-003 Only
30µg GEN-003
Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Experimental: High Dose GEN-003 Only
100µg GEN-003
Biological: GEN-003
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Placebo Comparator: Placebo
0.5 mL phosphate buffered saline
Biological: Placebo
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
Other Names:
  • PBS
  • DPBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: 57 Weeks
57 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in proportion of days with detectable viral shedding
Time Frame: 6 weeks
6 weeks
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time Frame: 33 weeks
33 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 (Actual)

July 1, 2012

Primary Completion (Actual)

May 9, 2014

Study Completion (Actual)

May 9, 2014

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-003-001

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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