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

NCT02300142 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-10-16

No results posted yet for this study

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.

Conditions

  • Genital Herpes Simplex Type 2

Interventions

BIOLOGICAL

GEN-003 Vaccine (30μg of each antigen)

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

BIOLOGICAL

GEN-003 Vaccine (60μg of each antigen)

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

BIOLOGICAL

Matrix-M2 Adjuvant (25μg)

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

BIOLOGICAL

Matrix-M2 Adjuvant (50μg)

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

BIOLOGICAL

Matrix-M2 Adjuvant (75μg)

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

Sponsors & Collaborators

  • Genocea Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02300142 on ClinicalTrials.gov