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

Genital Herpes Simplex Type 2 Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Genital Herpes Simplex Type 2
• Herpes Genitalis
• Herpes Simplex

• NCT number: NCT02300142
• Study type: Interventional
• Source: Genocea Biosciences, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Completion date: June 2016