Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
NCT ID: NCT02030301
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
PHASE1/PHASE2
165 participants
INTERVENTIONAL
2013-12-31
2016-02-29
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, 0.25-mL dose
VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
PBS, 0.25-mL dose
PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses
PBS
Phosphate-buffered saline
VCL-HB01, 0.5-mL dose
VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
PBS, 0.5-mL dose
PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses
PBS
Phosphate-buffered saline
VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
VCL-HM01, 1-mL dose
VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses
VCL-HM01
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
PBS, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses
PBS
Phosphate-buffered saline
Interventions
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VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
VCL-HM01
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
PBS
Phosphate-buffered saline
Eligibility Criteria
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Inclusion Criteria
* A minimum of 1 year of reported history of genital herpes and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy
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, Jr., MD, FIDSA
Role: STUDY_DIRECTOR
Vical
Locations
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Alabama Vaccine Research Clinic
Birmingham, Alabama, United States
Broward Research Group
Hollywood, Florida, United States
Indiana University Infectious Diseases Research
Indianapolis, Indiana, United States
Westover Heights Clinic
Portland, Oregon, United States
Center for Clinical Studies
Houston, Texas, United States
University of Utah - Division of Infectious Diseases
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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HSV2-101
Identifier Type: -
Identifier Source: org_study_id
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