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

Genital Herpes Simplex Type 2 Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02030301
Study type	Interventional
Source	Vical
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	December 2013
Completion date	February 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02910284` - Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity	N/A
Completed	`NCT02515175` - Evaluating New Formulation of Therapeutic HSV-2 Vaccine	Phase 2
Completed	`NCT02114060` - Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine	Phase 2
Completed	`NCT01667341` - Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine	Phase 1/Phase 2
Completed	`NCT02300142` - Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study	Phase 2
Recruiting	`NCT05432583` - A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions	Phase 1