NCT02114060

Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine

A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects With Genital HSV-2 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: * Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. * Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: * Time to first clinical and/or virologic recurrence, * 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 swabbing periods. * Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: * Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. * Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-04-15
• Last updated: 2017-10-16

Locations

16 sites across 1 country: United States