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

Vical

Status and phase: Completed; Phase 2; Phase 1

Conditions: Genital Herpes Simplex Type 2

Treatments: Biological: PBS; Biological: VCL-HB01; Biological: VCL-HM01

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030301

HSV2-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 165 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 7 patient groups, including a placebo group

VCL-HB01, 0.25-mL dose

Experimental group

Description:

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

Treatment:

Biological: VCL-HB01

PBS, 0.25-mL dose

Placebo Comparator group

Description:

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

Treatment:

Biological: PBS

VCL-HB01, 0.5-mL dose

Experimental group

Description:

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

Treatment:

Biological: VCL-HB01

PBS, 0.5-mL dose

Placebo Comparator group

Description:

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

Treatment:

Biological: PBS

VCL-HB01, 1-mL dose

Experimental group

Description:

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

Treatment:

Biological: VCL-HB01

VCL-HM01, 1-mL dose

Experimental group

Description:

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

Treatment:

Biological: VCL-HM01

PBS, 1-mL dose

Placebo Comparator group

Description:

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

Treatment:

Biological: PBS