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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02515175
Other study ID # GEN-003-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2015
Est. completion date May 25, 2017

Study information

Verified date May 2018
Source Genocea Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Intervention

Biological:
Matrix-M2
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Drug:
Placebo
0.9% Normal Saline

Locations

Country Name City State
United States Tekton Research Austin Texas
United States University of Alabama-Birmingham Birmingham Alabama
United States The Fenway Institute Boston Massachusetts
United States University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Cincinnati Childrens Hospital Cincinnati Ohio
United States Medical Center for Clinical Research San Diego California
United States Quest Clinical Research San Francisco California
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Genocea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HSV-2 viral shedding rate baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary Immunogenicity measured by humoral (antibody) responses to vaccine antigens 13 weeks
Secondary Impact on clinical HSV-2 disease based on time to first recurrence 64 weeks
Secondary Number of patients with adverse events as a measure of safety and tolerability 64 weeks
Secondary Reduction in HSV-2 viral shedding rate After vaccination (6 Months and 12 Months)
Secondary Impact on clinical HSV-2 disease based on lesion rate 64 weeks
Secondary Impact on clinical HSV-2 disease based on percent recurrence-free 64 weeks
See also
  Status Clinical Trial Phase
Completed NCT02910284 - Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity N/A
Completed NCT02114060 - Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine Phase 2
Completed NCT01667341 - Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine Phase 1/Phase 2
Completed NCT02300142 - Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study Phase 2
Recruiting NCT05432583 - A Clinical Trial in Healthy Volunteers to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions Phase 1
Completed NCT02030301 - Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults Phase 1/Phase 2