Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

Vical

Status and phase: Completed; Phase 2

Conditions: Herpes Genitalis

Treatments: Biological: VCL-HB01; Other: Phosphate-buffered saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02837575

HSV2-201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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261 participants in 2 patient groups, including a placebo group

VCL-HB01, 1-mL dose

Experimental group

Description:

VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses

Treatment:

Biological: VCL-HB01

Phosphate-buffered saline, 1-mL dose

Placebo Comparator group

Description:

PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses

Treatment:

Other: Phosphate-buffered saline