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Evaluating New Formulation of Therapeutic HSV-2 Vaccine

NCT02515175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2018-05-22

No results posted yet for this study

Summary

This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.

Conditions

  • Genital Herpes Simplex Type 2

Interventions

BIOLOGICAL

Matrix-M2

Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.

BIOLOGICAL

GEN-003

HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D

DRUG

Placebo

0.9% Normal Saline

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-07-31
Completion
2017-05-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02515175 on ClinicalTrials.gov