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

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.

Timeline

Start

2017-05-24

Primary completion

2017-12-22

Completion

2018-06-11

Outcome

Missed primary endpoint

Stopped (Business): “2017 business decision to cease GEN-003 spending.”

registry analysis (superiority test); GEN-003 vs Placebo; p = 0.7474; Wilcoxon (Mann-Whitney) NCT03146403 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GEN-003	Vaccine	60 ug	Intramuscular
Background	Matrix-M2	Other / unclassified	50 ug	Intramuscular

Indications