NCT02300142

Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study

Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 - Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) * Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine * Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period * Antiviral use. * To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
BIOLOGICAL	GEN-003 Vaccine (30μg of each antigen)	HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
BIOLOGICAL	GEN-003 Vaccine (60μg of each antigen)	HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
BIOLOGICAL	Matrix-M2 Adjuvant (25μg)	Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
BIOLOGICAL	Matrix-M2 Adjuvant (50μg)	Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
BIOLOGICAL	Matrix-M2 Adjuvant (75μg)	Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-11-24
• Last updated: 2017-10-16

Locations

16 sites across 1 country: United States