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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Subj

Brief 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.

Detailed Summary:
Sponsor: Genocea Biosciences, Inc.

Current Primary Outcome: Impact on clinical HSV-2 disease based on time to recurrence and lesion rate [ Time Frame: 53 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 57 weeks ]

Original Secondary Outcome: Same as current

Information By: Genocea Biosciences, Inc.

Dates:
Date Received: November 20, 2014
Date Started: January 2015
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016