Overview

This trial is active, not recruiting.

Condition genital herpes simplex type 2
Treatments matrix-m2, gen-003, placebo
Phase phase 2
Sponsor Genocea Biosciences, Inc.
Start date November 2015
End date July 2016
Trial size 131 participants
Trial identifier NCT02515175, GEN-003-003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (50ug), administered as a 0.5mL intramuscular (IM) injection
matrix-m2 Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
gen-003 HSV Therapeutic Vaccine
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
(Experimental)
GEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
matrix-m2 Adjuvant
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
gen-003 HSV Therapeutic Vaccine
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
(Placebo Comparator)
0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
placebo 0.9% Normal Saline
0.9% Normal Saline

Primary Outcomes

Measure
Change in HSV-2 viral shedding rate
time frame: baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria - A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive antiviral therapy, a history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation of antiviral suppressive therapy - Diagnosis of genital HSV-2 infection for > 1 year - Willing and able to provide written informed consent - Willing to perform and comply with all study procedures including attending clinic visits as scheduled and completion of an electronic lesion report form - Willing to not use suppressive antiviral therapy from 14 days prior to starting the study and for the duration of the study - Men and women must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, tubal ligation, hysterectomy, licensed hormonal methods, intrauterine device, or barrier method (e.g., condom, diaphragm) with spermicide for 28 days before and 90 days after receiving the Study Drug Exclusion Criteria - On suppressive antiviral therapy within 14 days of starting the study - Use of topical steroids or antiviral medication in the anogenital region within 14 days of starting the study and during study - Use of tenofovir, lysine, or other medication or supplement known or purported to affect HSV outbreak frequency or intensity within 14 days of starting the study - History of any form of ocular HSV infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis - Immunocompromised individuals - Use of corticosteroids within 30 days of starting the study and during the study or other immunosuppressive agents - Presence or history of autoimmune disease regardless of current treatment - Current infection with HIV or hepatitis B or C virus - History of hypersensitivity to any component of the vaccine - Prior receipt of GEN-003 or another vaccine containing HSV-2 antigens - Receipt of any investigational product within 30 days prior to Dose 1 - Receipt of blood products within 90 days prior to Dose 1 - Planned use of any vaccine over the course of the study - Pregnant or nursing women - History of drug or alcohol abuse - Other active, uncontrolled comorbidities

Additional Information

Official title A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Genocea Biosciences, Inc..