NCT03146403

Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

A Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of a Maintenance Dose of GEN-003 in Subjects With Genital Herpes Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.

Detailed description

This study is a randomized, double-blind, placebo-controlled clinical trial of GEN-003 in subjects who have received previous doses of GEN-003 in the GEN-003-003 clinical trial. Eligible subjects will be randomized in a 1:1 ratio to receive 1 intramuscular (IM) dose (the maintenance dose) of GEN-003 or placebo. Subjects will use a daily electronic reporting tool for reporting the presence or absence of genital herpes lesions, and severity of genital herpes symptoms. GEN-003-005 was originally designed to follow subjects for 12 months after the maintenance dose but a business decision, unrelated to product safety, was made by Genocea Biosciences in 3Q2017 to cease GEN-003 spending and activities.

Conditions

• Genital Herpes
• HSV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	GEN-003	HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
BIOLOGICAL	Matrix-M2	Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
OTHER	0.9% normal saline	Placebo

Timeline

• Start date: 2017-05-24
• Primary completion: 2017-12-22
• Completion: 2018-06-11
• First posted: 2017-05-09
• Last updated: 2019-02-19
• Results posted: 2019-02-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study