Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine (HSV-2)
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ClinicalTrials.gov Identifier: NCT02837575 |
Recruitment Status :
Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : May 7, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herpes Genitalis | Biological: VCL-HB01 Other: Phosphate-buffered saline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 261 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection |
Study Start Date : | September 2016 |
Actual Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | July 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: VCL-HB01, 1-mL dose
VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses
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Biological: VCL-HB01
Investigational Product |
Placebo Comparator: Phosphate-buffered saline, 1-mL dose
PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses
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Other: Phosphate-buffered saline
Placebo
Other Name: PBS |
- Lesion recurrences [ Time Frame: Up to Day 450 ]
- Number of participants with adverse events [ Time Frame: Up to Day 450 ]
- Time to first recurrence [ Time Frame: Up to Day 450 ]
- Proportion of subjects recurrence-free [ Time Frame: Up to Day 450 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- HSV-2 seropositive
- A minimum of 1 year of reported history of genital herpes with recurrences.
Exclusion Criteria:
- History of receiving an investigational HSV vaccine
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837575
United States, Alabama | |
Alabama Vaccine Research Clinic at University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294-2050 | |
United States, California | |
Medical Center for Clinical Research | |
San Diego, California, United States, 92108 | |
United States, Florida | |
QPS Broward Research | |
Hollywood, Florida, United States, 33024 | |
QPS Miami Research Associates | |
South Miami, Florida, United States, 33143 | |
Comprehensive Clinical Trials, LLC | |
West Palm Beach, Florida, United States, 33409 | |
United States, Illinois | |
University of Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Indiana University Infectious Disease Research | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kansas | |
Heartland Research Associates, LLC | |
Wichita, Kansas, United States, 67207 | |
United States, Kentucky | |
Central Kentucky Research Associates, Inc. | |
Lexington, Kentucky, United States, 40509 | |
United States, Missouri | |
The Center for Pharmaceutical Research | |
Kansas City, Missouri, United States, 64114 | |
United States, New York | |
Rochester Clinical Research, Inc. | |
Rochester, New York, United States, 14609 | |
United States, North Carolina | |
University of North Carolina (UNC) Institute of Global Health and Infectious Diseases | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Tennessee | |
Clinical Research Associates, Inc. | |
Nashville, Tennessee, United States, 37203 | |
United States, Utah | |
University of Utah School of Medicine - Division of Infectious Diseases | |
Salt Lake City, Utah, United States, 84132 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98104 |
Study Director: | Mammen P Mammen, MD, FIDSA | Vical |
Responsible Party: | Vical |
ClinicalTrials.gov Identifier: | NCT02837575 History of Changes |
Other Study ID Numbers: |
HSV2-201 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | May 7, 2018 |
Last Verified: | May 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Vical:
HSV-2 Genital Herpes Herpes Herpes Simplex Virus, Type 2 |
Additional relevant MeSH terms:
Herpes Simplex Herpes Genitalis Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female |