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Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

Primary Purpose

Genital Herpes Simplex Type 2

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GEN-003 with Matrix M-2
GEN-003
Placebo
Sponsored by
Genocea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes Simplex Type 2 focused on measuring HSV, Herpes, genital infection, vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama Vaccine Research Unit
  • Indiana University Infectious Disease Research
  • Cincinnati Children's Hospital Medical Center
  • Westover Heights Clinic
  • Center for Clinical Studies - Houston
  • Center for Clinical Studies - Clear Lake/Webster
  • UW Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low Dose GEN-003 with Matrix M-2

Mid Dose GEN-003 with Matrix M-2

High Dose GEN-003 with Matrix M-2

Low Dose GEN-003 Only

Mid Dose GEN-003 Only

High Dose GEN-003 Only

Placebo

Arm Description

10µg GEN-003, 50µg Matrix M-2 Adjuvant

30µg GEN-003, 50µg Matrix M-2 Adjuvant

100µg GEN-003, 50µg Matrix M-2 Adjuvant

10µg GEN-003

30µg GEN-003

100µg GEN-003

0.5 mL phosphate buffered saline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Change in proportion of days with detectable viral shedding

Full Information

First Posted
August 14, 2012
Last Updated
May 30, 2018
Sponsor
Genocea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01667341
Brief Title
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
May 9, 2014 (Actual)
Study Completion Date
May 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genocea Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose) GEN-003: Antigens alone 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes Simplex Type 2
Keywords
HSV, Herpes, genital infection, vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose GEN-003 with Matrix M-2
Arm Type
Experimental
Arm Description
10µg GEN-003, 50µg Matrix M-2 Adjuvant
Arm Title
Mid Dose GEN-003 with Matrix M-2
Arm Type
Experimental
Arm Description
30µg GEN-003, 50µg Matrix M-2 Adjuvant
Arm Title
High Dose GEN-003 with Matrix M-2
Arm Type
Experimental
Arm Description
100µg GEN-003, 50µg Matrix M-2 Adjuvant
Arm Title
Low Dose GEN-003 Only
Arm Type
Experimental
Arm Description
10µg GEN-003
Arm Title
Mid Dose GEN-003 Only
Arm Type
Experimental
Arm Description
30µg GEN-003
Arm Title
High Dose GEN-003 Only
Arm Type
Experimental
Arm Description
100µg GEN-003
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.5 mL phosphate buffered saline
Intervention Type
Biological
Intervention Name(s)
GEN-003 with Matrix M-2
Intervention Description
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
Intervention Type
Biological
Intervention Name(s)
GEN-003
Intervention Description
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBS, DPBS
Intervention Description
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
Primary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
57 Weeks
Secondary Outcome Measure Information:
Title
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time Frame
33 weeks
Title
Change in proportion of days with detectable viral shedding
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alabama Vaccine Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
Indiana University Infectious Disease Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Westover Heights Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Clinical Studies - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies - Clear Lake/Webster
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
UW Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28329211
Citation
Bernstein DI, Wald A, Warren T, Fife K, Tyring S, Lee P, Van Wagoner N, Magaret A, Flechtner JB, Tasker S, Chan J, Morris A, Hetherington S. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial. J Infect Dis. 2017 Mar 15;215(6):856-864. doi: 10.1093/infdis/jix004.
Results Reference
derived

Learn more about this trial

Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

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