Clinical trial NCT02030301: Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Genital Herpes Simplex Type 2
Keywords: Herpes Simplex Virus, Type 2
Herpes
HSV-2
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 165
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 study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Day 420
measure: Viral shedding rate change from baseline
timeFrame: Baseline, Day 150
Secondary outcomes:
measure: Genital lesion rate change from baseline
timeFrame: Baseline, Day 150
measure: HSV DNA copy numbers change from baseline
timeFrame: Baseline, Day 150
measure: Genital recurrence rate compared with placebo
timeFrame: Up to Day 330
measure: Subclinical genital shedding rate change from baseline
timeFrame: Up to Day 150
measure: T-cell and/or antibody responses change from baseline
timeFrame: Baseline, Days 7, 35, 63, 150, 330
Other outcomes:
measure: Genital shedding rate change from baseline over time
timeFrame: Baseline, Day 330
measure: Genital lesion rate change from baseline
timeFrame: Baseline, Day 330
measure: Subclinical genital shedding rate change from baseline
timeFrame: Baseline, Day 330
Locations:
city: Birmingham
country: United States
facility: Alabama Vaccine Research Clinic
state: Alabama
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Infectious Diseases Research
state: Indiana
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Division of Infectious Diseases
state: Utah
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Vical
name: Mammen P. Mammen, Jr., MD, FIDSA
role: STUDY_DIRECTOR
References: