Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
NCT ID: NCT02837575
Last Updated: 2019-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
261 participants
INTERVENTIONAL
2016-09-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
VCL-HB01
Investigational Product
Phosphate-buffered saline, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
Phosphate-buffered saline
Placebo
Interventions
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VCL-HB01
Investigational Product
Phosphate-buffered saline
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A minimum of 1 year of reported history of genital herpes with recurrences.
Exclusion Criteria
* Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
* Pregnant or breastfeeding
18 Years
50 Years
ALL
Yes
Sponsors
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Vical
INDUSTRY
Responsible Party
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Principal Investigators
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Mammen P Mammen, MD, FIDSA
Role: STUDY_DIRECTOR
Vical
Locations
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Alabama Vaccine Research Clinic at University of Alabama at Birmingham
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
QPS Broward Research
Hollywood, Florida, United States
QPS Miami Research Associates
South Miami, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
University of Illinois
Chicago, Illinois, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
Chapel Hill, North Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
University of Utah School of Medicine - Division of Infectious Diseases
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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HSV2-201
Identifier Type: -
Identifier Source: org_study_id
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