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Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults

Sponsor
Vical (Industry)
Overall Status
Completed
CT.gov ID
NCT02030301
Collaborator
(none)
165
Enrollment
7
Locations
7
Arms
26
Duration (Months)
23.6
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).

Condition or Disease Intervention/Treatment Phase
  • Biological: VCL-HB01
  • Biological: VCL-HM01
  • Biological: PBS
 Phase 1/Phase 2

Detailed Description

This is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of HSV plasmid DNA (pDNA) vaccines formulated with Vaxfectin® in subjects with 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: VCL-HB01, 0.25-mL dose

VCL-HB01, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.25-mL dose

PBS, 0.25-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: PBS
Phosphate-buffered saline
Experimental: VCL-HB01, 0.5-mL dose

VCL-HB01, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Placebo Comparator: PBS, 0.5-mL dose

PBS, 0.5-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: PBS
Phosphate-buffered saline
Experimental: VCL-HB01, 1-mL dose

VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: VCL-HB01
Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
Experimental: VCL-HM01, 1-mL dose

VCL-HM01, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: VCL-HM01
Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
Placebo Comparator: PBS, 1-mL dose

PBS, 1-mL dose by intramuscular injection once every 28 days for 3 doses

Biological: PBS
Phosphate-buffered saline

Outcome Measures

Primary Outcome Measures

  1. Number of participants with adverse events [Up to Day 420]

  2. Viral shedding rate change from baseline [Baseline, Day 150]

Secondary Outcome Measures

  1. Genital lesion rate change from baseline [Baseline, Day 150]

  2. HSV DNA copy numbers change from baseline [Baseline, Day 150]

  3. Genital recurrence rate compared with placebo [Up to Day 330]

  4. Subclinical genital shedding rate change from baseline [Up to Day 150]

  5. T-cell and/or antibody responses change from baseline [Baseline, Days 7, 35, 63, 150, 330]

Other Outcome Measures

  1. Genital shedding rate change from baseline over time [Baseline, Day 330]

  2. Genital lesion rate change from baseline [Baseline, Day 330]

  3. Subclinical genital shedding rate change from baseline [Baseline, Day 330]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
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 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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alabama Vaccine Research Clinic Birmingham Alabama United States 35294
2 Broward Research Group Hollywood Florida United States 33024
3 Indiana University Infectious Diseases Research Indianapolis Indiana United States 46202
4 Westover Heights Clinic Portland Oregon United States 97210
5 Center for Clinical Studies Houston Texas United States 77004
6 University of Utah - Division of Infectious Diseases Salt Lake City Utah United States 84132
7 University of Washington Medical Center Seattle Washington United States 98104

Sponsors and Collaborators

  • Vical

Investigators

  • Study Director: Mammen P. Mammen, Jr., MD, FIDSA, Vical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vical
ClinicalTrials.gov Identifier:
NCT02030301
Other Study ID Numbers:
  • HSV2-101
First Posted:
Jan 8, 2014
Last Update Posted:
Feb 27, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vical
Herpes Simplex Virus, Type 2
Herpes
HSV-2
Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis

Study Results

No Results Posted as of Feb 27, 2019