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

NCT03146403 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-02-19

Study results available
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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.

Conditions

  • Genital Herpes
  • HSV-2 Infection

Interventions

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

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2017-12-22
Completion
2018-06-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146403 on ClinicalTrials.gov