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
1 other identifier
interventional
143
1 country
7
Brief 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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2012
7 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
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2014
CompletedJune 1, 2018
May 1, 2018
1.9 years
August 14, 2012
May 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
57 Weeks
Secondary Outcomes (2)
Immunogenicity measured by humoral (antibody) and T-cell responses to vaccine antigens
33 weeks
Change in proportion of days with detectable viral shedding
6 weeks
Study Arms (7)
Low Dose GEN-003 with Matrix M-2
EXPERIMENTAL10µg GEN-003, 50µg Matrix M-2 Adjuvant
Mid Dose GEN-003 with Matrix M-2
EXPERIMENTAL30µg GEN-003, 50µg Matrix M-2 Adjuvant
High Dose GEN-003 with Matrix M-2
EXPERIMENTAL100µg GEN-003, 50µg Matrix M-2 Adjuvant
Low Dose GEN-003 Only
EXPERIMENTAL10µg GEN-003
Mid Dose GEN-003 Only
EXPERIMENTAL30µg GEN-003
High Dose GEN-003 Only
EXPERIMENTAL100µg GEN-003
Placebo
PLACEBO COMPARATOR0.5 mL phosphate buffered saline
Interventions
IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
Eligibility Criteria
You may qualify if:
- Men and women ages 18 to 50 years, inclusive.
- Willing to practice a highly effective method of contraception that includes the use of a barrier method such as a condom.
- Diagnosis of genital HSV-2 infection for \> 1 year supported by ONE of the following documented in the medical history or performed at screening:
- Western blot for HSV-2
- Type-specific polymerase chain reaction (PCR) or viral culture
- Compatible clinical history AND HSV-2 ELISA (HerpSelect) index value \>3.5
- A history of at least 3 and no more than 9 reported clinical occurrences in the prior 12 months, or, if currently on suppressive therapy, history of at least 3 and no more than 9 reported clinical occurrences in the 12 months prior to initiation suppressive therapy.
- Good general health status as determined by screening evaluation completed within 90 days prior to immunization. Any out of range screening clinical laboratory values should be considered not clinically significant by the Investigator.
- Patient has provided written informed consent.
- Ability and willingness to perform and comply with all study procedures including attending clinic visits as scheduled. Note: patients must provide, by the day of randomization, a minimum of 28 (equivalent of 14 days) baseline viral swab samples to continue to be eligible and be randomized).
You may not qualify if:
- On suppressive antiviral medication within 7 days of baseline viral shedding evaluation.
- Immunocompromised individuals, including those receiving systemic corticosteroids or other immunosuppressive agents.
- Positive serologic test for HIV-1 infection; positive hepatitis B surface antigen (HBsAg) or antibody for hepatitis C (anti-HCV).
- Active lesions consistent with herpetic disease at the time of scheduled immunization.
- Pregnant or nursing women.
- Receipt of any investigational drug within 30 days of the first scheduled day of immunization.
- History of hypersensitivity to any component of the vaccine.
- History of genital HSV-1 infection.
- History of: (1) any form of ocular HSV infection, (2) HSV-related erythema multiforme, or (3) herpes meningitis or encephalitis.
- Any other condition which in the opinion of the Investigator would interfere with the successful completion of the study protocol.
- History of drug or alcohol abuse that, in the opinion of the Investigator, would interfere with the patient's ability to comply with the requirements of the study.
- Prior immunization with a vaccine containing HSV-2 antigens.
- Receipt of blood products within 90 days of the first immunization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama Vaccine Research Unit
Birmingham, Alabama, 35294-0006, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, 46202, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Center for Clinical Studies - Houston
Houston, Texas, 77030, United States
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, 77598, United States
UW Virology Research Clinic
Seattle, Washington, 98104, United States
Related Publications (1)
Bernstein DI, Wald A, Warren T, Fife K, Tyring S, Lee P, Van Wagoner N, Magaret A, Flechtner JB, Tasker S, Chan J, Morris A, Hetherington S. Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial. J Infect Dis. 2017 Mar 15;215(6):856-864. doi: 10.1093/infdis/jix004.
PMID: 28329211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 17, 2012
Study Start
July 1, 2012
Primary Completion
May 9, 2014
Study Completion
May 9, 2014
Last Updated
June 1, 2018
Record last verified: 2018-05