Evaluating New Formulation of Therapeutic HSV-2 Vaccine
A Randomized, Double-Blind Study to Evaluate a New Formulation of GEN-003 in Subjects With Genital HSV-2 Infection
1 other identifier
interventional
131
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2015
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2015
CompletedFirst Posted
Study publicly available on registry
August 4, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedMay 22, 2018
May 1, 2018
8 months
July 31, 2015
May 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HSV-2 viral shedding rate
baseline (Days -28 to Day 1) and after vaccination (Days 43 to 71)
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
GEN-003 60ug / Matrix-M2 50ug
EXPERIMENTALGEN-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
EXPERIMENTALGEN-003/M2 (60 ug of each antigen) with Matrix-M2 adjuvant (75ug), administered as a 0.5mL intramuscular (IM) injection
Placebo
PLACEBO COMPARATOR0.9% Normal Saline administered as a 0.5 mL intramuscular (IM) injection
Interventions
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of Alabama-Birmingham
Birmingham, Alabama, 35294, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Quest Clinical Research
San Francisco, California, 94115, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229, United States
Tekton Research
Austin, Texas, 78745, United States
University of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
Bernstein DI, Flechtner JB, McNeil LK, Heineman T, Oliphant T, Tasker S, Wald A, Hetherington S; Genocea study group. Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease. Vaccine. 2019 Jun 6;37(26):3443-3450. doi: 10.1016/j.vaccine.2019.05.009. Epub 2019 May 15.
PMID: 31103365DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2015
First Posted
August 4, 2015
Study Start
November 1, 2015
Primary Completion
July 1, 2016
Study Completion
May 25, 2017
Last Updated
May 22, 2018
Record last verified: 2018-05