NCT02515175

Evaluating New Formulation of Therapeutic HSV-2 Vaccine

A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

Detailed description

This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
BIOLOGICAL	Matrix-M2	Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
BIOLOGICAL	GEN-003	HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
DRUG	Placebo	0.9% Normal Saline

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-07-01
• Completion: 2017-05-25
• First posted: 2015-08-04
• Last updated: 2018-05-22

Locations

8 sites across 1 country: United States