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CompletedNCT02300142Updated Oct 16, 2017

Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study

A Phase 2 interventional study of GEN-003 Vaccine (30μg of each antigen) and GEN-003 Vaccine (60μg of each antigen) in Genital Herpes Simplex Type 2, sponsored by Genocea Biosciences, Inc.. Completed at 16 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Genocea Biosciences, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.

Objectives:

  • To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

    • Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
    • Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine
    • Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period
    • Antiviral use.
  • To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
02

Conditions studied

  • Genital Herpes Simplex Type 2

Keywords

  • HSV
  • Herpes
  • genital infection
  • vaccine
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 37 is below the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Genocea Biosciences, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71.
  2. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
  3. Willing and able to provide written informed consent.
  4. Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
  5. Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug.

Exclusion criteria

Exclusion Criteria:

  1. On suppressive antiviral medication within 7 days prior to the first dose of Study Drug.
  2. Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
  3. History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
  4. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
  5. Presence or history of autoimmune disease, regardless of current treatment.
  6. Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection (in the absence of a negative PCR result); positive hepatitis B surface antigen (HBsAg) within 6 months prior to the first dose of Study Drug.
  7. Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug.
  8. Receipt of blood products within 90 days prior to the first dose of Study Drug.
  9. Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
  10. Pregnant or nursing women.
  11. 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.
  12. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.

NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    GEN-003 Vaccine 30μg / Matrix-M 25μg

    GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (30μg of each antigen) · Biological: Matrix-M2 Adjuvant (25μg)

  • Experimental
    GEN-003 Vaccine 30μg / Matrix-M2 50μg

    GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (30μg of each antigen) · Biological: Matrix-M2 Adjuvant (50μg)

  • Experimental
    GEN-003 Vaccine 30μg / Matrix-M2 75μg

    GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (30μg of each antigen) · Biological: Matrix-M2 Adjuvant (75μg)

  • Experimental
    GEN-003 Vaccine 60μg / Matrix-M2 25μg

    GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (60μg of each antigen) · Biological: Matrix-M2 Adjuvant (25μg)

  • Experimental
    GEN-003 Vaccine 60μg / Matrix-M2 50μg

    GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (60μg of each antigen) · Biological: Matrix-M2 Adjuvant (50μg)

  • Experimental
    GEN-003 Vaccine 60μg / Matrix-M2 75μg

    GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.

    Biological: GEN-003 Vaccine (60μg of each antigen) · Biological: Matrix-M2 Adjuvant (75μg)

Interventions

  • BiologicalGEN-003 Vaccine (30μg of each antigen)

    HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

    Also known as: HSV Vaccine

  • BiologicalGEN-003 Vaccine (60μg of each antigen)

    HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

    Also known as: HSV Vaccine

  • BiologicalMatrix-M2 Adjuvant (25μg)

    Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

    Also known as: MM2, Adjuvant

  • BiologicalMatrix-M2 Adjuvant (50μg)

    Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

    Also known as: MM2, Adjuvant

  • BiologicalMatrix-M2 Adjuvant (75μg)

    Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

    Also known as: MM2, Adjuvant

06

What researchers measure

Primary outcomes

  1. Impact on clinical HSV-2 disease based on time to recurrence and lesion rate

    Time frame: 53 weeks

Secondary outcomes

  1. Number of patients with adverse events as a measure of safety and tolerability

    Time frame: 57 weeks

07

Study locations

16 sites
  • University of Alabama Vaccine Research Unit
    Birmingham, Alabama 35294-0006, United States
  • Medical Center for Clinical Research
    San Diego, California 92108, United States
  • Quest Clinical Research
    San Francisco, California 94115, United States
  • University of Illinois Department of Medicine
    Chicago, Illinois 60612, United States
  • Indiana University Infectious Disease Research
    Indianapolis, Indiana 46202, United States
  • The Fenway Institute
    Boston, Massachusetts 02215, United States
  • UNC Global HIV Prevention and Treatment Clinical Trials Unit
    Chapel Hill, North Carolina 27599, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229-3039, United States
  • Westover Heights Clinic
    Portland, Oregon 97210, United States
  • Magee-Womens Hospital of UPMC
    Pittsburgh, Pennsylvania 15213, United States
  • Tekton Research
    Austin, Texas 98745, United States
  • Center for Clinical Studies - Houston
    Houston, Texas 77030, United States
  • Center for Clinical Studies
    Houston, Texas 77065, United States
  • Center for Clinical Studies - Clear Lake/Webster
    Webster, Texas 77598, United States
  • University of Utah
    Salt Lake City, Utah 84132, United States
  • UW Virology Research Clinic
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02300142
Lead sponsor
Genocea Biosciences, Inc.
Responsible party
Sponsor
First posted
Nov 24, 2014
Start date
Jan 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 16, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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