Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

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.

BIOLOGICAL

Placebo

0.9% Normal Saline (NaCl)

Trial Locations (16)

15213

Magee-Womens Hospital of UPMC, Pittsburgh

27599

UNC Global HIV Prevention and Treatment Clinical Trials Unit, Chapel Hill

46202

Indiana University Infectious Disease Research, Indianapolis

60612

University of Illinois Department of Medicine, Chicago

77030

Center for Clinical Studies - Houston, Houston

77065

Center for Clinical Studies, Houston

77598

Center for Clinical Studies - Clear Lake/Webster, Webster

84132

University of Utah, Salt Lake City

92108

Medical Center for Clinical Research, San Diego

94115

Quest Clinical Research, San Francisco

97210

Westover Heights Clinic, Portland

98104

UW Virology Research Clinic, Seattle

98745

Tekton Research, Austin

35294-0006

University of Alabama Vaccine Research Unit, Birmingham

02215

The Fenway Institute, Boston

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

Sponsors
All Listed Sponsors
lead

Genocea Biosciences, Inc.

INDUSTRY