NCT01667341

Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine

A Phase I/IIa, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study of the Safety and Immunogenicity of a HSV-2 Vaccine Containing Matrix M-2 Adjuvant in Individuals With Documented Genital HSV-2 Genital Infection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Genocea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each cohort, patients will be randomized at a ratio of 3:1:1 to one of the following: 1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose) 2. GEN-003: Antigens alone 3. Placebo (DPBS diluent) Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon successful review of data from the Pilot Group through Day 7 after immunization. Dose escalation to the next dose level Cohort proceeds after evaluation of safety data from all patients in the prior Cohort and only after all specified safety criteria are met. The total numbers of patients in each Group and Cohort are as follows: * 10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * 30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * 100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total) * Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients) Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization.

Conditions

• Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
BIOLOGICAL	GEN-003 with Matrix M-2	IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
BIOLOGICAL	GEN-003	IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
BIOLOGICAL	Placebo	IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-05-09
• Completion: 2014-05-09
• First posted: 2012-08-17
• Last updated: 2018-06-01

Locations

7 sites across 1 country: United States