- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02114060
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection
This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant.
Secondary objectives of the study include:
- Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo.
Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
- Time to first clinical and/or virologic recurrence,
- 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 swabbing periods.
- Evaluation of cellular and humoral responses to GEN-003 antigens.
Additional objectives include:
- Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above.
- Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study.
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. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294-0006
- University of Alabama Vaccine Research Unit
-
-
California
-
San Diego, California, United States, 92108
- Medical Center for Clinical Research
-
San Francisco, California, United States, 94115
- Quest Clinical Research
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois Department of Medicine
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Infectious Disease Research
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- The Fenway Institute
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Global HIV Prevention and Treatment Clinical Trials Unit
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229-3039
- Cincinnati Children's Hospital Medical Center
-
-
Oregon
-
Portland, Oregon, United States, 97210
- Westover Heights Clinic
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital of UPMC
-
-
Texas
-
Austin, Texas, United States, 98745
- Tekton Research
-
Houston, Texas, United States, 77065
- Center for Clinical Studies
-
Houston, Texas, United States, 77030
- Center for Clinical Studies - Houston
-
Webster, Texas, United States, 77598
- Center for Clinical Studies - Clear Lake/Webster
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- University of Utah
-
-
Washington
-
Seattle, Washington, United States, 98104
- UW Virology Research Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and non-pregnant females, ages 18 to 50 years inclusive.
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
- Positive HerpeSelect® 2 Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G (IgG) with an index value >3.5, or
- Positive LIAISON® HSV-2 Type-Specific IgG
- 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 of suppressive therapy.
- Collection of at least 45 of 56 anogenital swabs during the baseline period.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- 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:
- On suppressive antiviral medication within 7 days of beginning baseline anogenital swab collection period.
- History of genital Herpes Simplex Virus type-1 (HSV-1) infection.
- History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
- 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.
- Presence or history of autoimmune disease, regardless of current treatment.
- Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection; positive hepatitis B surface antigen (HBsAg).
- Clinically significant laboratory abnormality or a value ≥ Grade 2.
- Prior immunization with a vaccine containing HSV-2 antigens.
- History of hypersensitivity to any component of the vaccine.
- Receipt of any investigational drug within 30 days prior to the first dose of Study Drug.
- Receipt of blood products within 90 days prior to the first dose of Study Drug.
- 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.
- Pregnant or nursing women.
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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:
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
|
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.
|
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:
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
|
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.
|
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:
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
|
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.
|
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
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:
|
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.
|
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
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:
|
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.
|
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Names:
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:
|
Placebo Comparator: Placebo
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection.
|
0.9% Normal Saline (NaCl)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in proportion of days with detectable viral shedding
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
Time Frame: 33 weeks
|
33 weeks
|
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
Time Frame: 53 weeks
|
53 weeks
|
Number of patients with adverse events as a measure of safety and tolerability
Time Frame: 57 weeks
|
57 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Herpes Simplex
- Herpes Genitalis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- GEN-003-002
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.
Clinical Trials on Genital Herpes Simplex Type 2
-
Genocea Biosciences, Inc.CompletedGenital Herpes Simplex Type 2United States
-
Genocea Biosciences, Inc.CompletedGenital Herpes Simplex Type 2United States
-
VicalCompletedGenital Herpes Simplex Type 2United States
-
Genocea Biosciences, Inc.Completed
-
Genocea Biosciences, Inc.CompletedGenital Herpes Simplex Type 2United States
-
Agenus Inc.CompletedHerpes Simplex Type 2United States
-
BioNTech SERecruiting
-
Global Research InstituteRational Vaccines IncRecruitingHIV Disease | Herpes Simplex 2 | Herpes Simplex 1United States
-
Kaiser PermanentePatient-Centered Outcomes Research InstituteRecruitingMaternal Morbidity | Racial Disparities | Genital Herpes SimplexUnited States
-
Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV Infections | HSV-2 Genital HerpesAustralia
Clinical Trials on GEN-003 Vaccine (30μg of each antigen)
-
Genocea Biosciences, Inc.CompletedGenital Herpes Simplex Type 2United States
-
Jiangsu Province Centers for Disease Control and...Changchun Institute of Biological Products Co., Ltd.Completed
-
Genocea Biosciences, Inc.TerminatedGenital Herpes | HSV-2 InfectionUnited States
-
Genocea Biosciences, Inc.Completed
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate CancerUnited States
-
GlaxoSmithKlineActive, not recruiting
-
Crucell Holland BVCompleted
-
Biomedical Advanced Research and Development AuthorityCompletedInfluenza A Virus, H5N1 SubtypeUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed