Evaluating New Formulation of Therapeutic HSV-2 Vaccine

Phase 2

Completed

• Conditions: Genital Herpes Simplex Type 2
• Interventions: Biological: Matrix-M2; Drug: Placebo; Biological: GEN-003

• Registration Number: NCT02515175
• Lead Sponsor: Genocea Biosciences, Inc.

Brief 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.

Detailed Description

This study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.

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 then complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each subject will be followed for one year after the third dose.

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2017-05-25
• Disposition First Submitted: 2017-09-11
• Disposition First Submitted QC: 2017-10-04
• Disposition First Posted: 2017-10-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEN-003 60ug / Matrix-M2 50ug	Matrix-M2	GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
GEN-003 60ug / Matrix-M2 50ug	GEN-003	GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
GEN-003 60ug / Matrix-M2 75ug	Matrix-M2	GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
GEN-003 60ug / Matrix-M2 75ug	GEN-003	GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
Placebo	Placebo	0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection

Primary Outcome Measures

Name	Time	Method
Change in HSV-2 viral shedding rate	baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)

Secondary Outcome Measures

Name	Time	Method
Immunogenicity measured by humoral (antibody) responses to vaccine antigens	13 weeks
Impact on clinical HSV-2 disease based on time to first recurrence	64 weeks
Number of patients with adverse events as a measure of safety and tolerability	64 weeks
Reduction in HSV-2 viral shedding rate	After vaccination (6 Months and 12 Months)
Impact on clinical HSV-2 disease based on lesion rate	64 weeks
Impact on clinical HSV-2 disease based on percent recurrence-free	64 weeks

Trial Locations

Locations (8)

The Fenway Institute; 🇺🇸 Boston, Massachusetts, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Medical Center for Clinical Research; 🇺🇸 San Diego, California, United States

University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Cincinnati Childrens Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Tekton Research; 🇺🇸 Austin, Texas, United States