Clinical trial NCT02837575: Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Genitalis
Keywords: HSV-2
Genital Herpes
Herpes
Herpes Simplex Virus, Type 2
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

Detailed description: To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Eligibility criteria: 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

Primary outcomes:
measure: Lesion recurrences
timeFrame: Up to Day 450
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Day 450
measure: Time to first recurrence
timeFrame: Up to Day 450
measure: Proportion of subjects recurrence-free
timeFrame: Up to Day 450
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine Research Clinic at University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Hollywood
country: United States
facility: QPS Broward Research
state: Florida
city: South Miami
country: United States
facility: QPS Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Infectious Disease Research
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) Institute of Global Health and Infectious Diseases
state: North Carolina
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine - Division of Infectious Diseases
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Vical
name: Mammen P Mammen, MD, FIDSA
role: STUDY_DIRECTOR
References: