Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Primary Purpose
Genital Herpes Simplex Type 2
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Matrix-M2
GEN-003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Genital Herpes Simplex Type 2 focused on measuring HSV, Herpes, Genital Herpes, Vaccine
Eligibility Criteria
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
Sites / Locations
- University of Alabama-Birmingham
- Medical Center for Clinical Research
- Quest Clinical Research
- The Fenway Institute
- University of North Carolina - Chapel Hill
- Cincinnati Childrens Hospital
- Tekton Research
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
GEN-003 60ug / Matrix-M2 50ug
GEN-003 60ug / Matrix-M2 75ug
Placebo
Arm Description
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
Outcomes
Primary Outcome Measures
Change in HSV-2 viral shedding rate
Secondary Outcome Measures
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Impact on clinical HSV-2 disease based on time to first recurrence
Number of patients with adverse events as a measure of safety and tolerability
Reduction in HSV-2 viral shedding rate
Impact on clinical HSV-2 disease based on lesion rate
Impact on clinical HSV-2 disease based on percent recurrence-free
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02515175
Brief Title
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Official Title
A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
May 25, 2017 (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
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.
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.
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 Herpes, Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GEN-003 60ug / Matrix-M2 50ug
Arm Type
Experimental
Arm Description
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
Arm Title
GEN-003 60ug / Matrix-M2 75ug
Arm Type
Experimental
Arm Description
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
Intervention Type
Biological
Intervention Name(s)
Matrix-M2
Other Intervention Name(s)
Adjuvant
Intervention Description
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Intervention Type
Biological
Intervention Name(s)
GEN-003
Other Intervention Name(s)
HSV Therapeutic Vaccine
Intervention Description
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% Normal Saline
Intervention Description
0.9% Normal Saline
Primary Outcome Measure Information:
Title
Change in HSV-2 viral shedding rate
Time Frame
baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary Outcome Measure Information:
Title
Immunogenicity measured by humoral (antibody) responses to vaccine antigens
Time Frame
13 weeks
Title
Impact on clinical HSV-2 disease based on time to first recurrence
Time Frame
64 weeks
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
64 weeks
Title
Reduction in HSV-2 viral shedding rate
Time Frame
After vaccination (6 Months and 12 Months)
Title
Impact on clinical HSV-2 disease based on lesion rate
Time Frame
64 weeks
Title
Impact on clinical HSV-2 disease based on percent recurrence-free
Time Frame
64 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
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
Facility Information:
Facility Name
University of Alabama-Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
The Fenway Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Childrens Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31103365
Citation
Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.
Results Reference
derived
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Evaluating New Formulation of Therapeutic HSV-2 Vaccine
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