Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
NCT ID: NCT02300142
Last Updated: 2017-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2015-01-31
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Objectives:
* To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:
* Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)
* Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine
* Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period
* Antiviral use.
* To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GEN-003 Vaccine 30μg / Matrix-M 25μg
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (30μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (25μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003 Vaccine 30μg / Matrix-M2 50μg
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (30μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (50μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003 Vaccine 30μg / Matrix-M2 75μg
GEN-003 Vaccine (30 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (30μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (75μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003 Vaccine 60μg / Matrix-M2 25μg
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (25 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (60μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (25μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003 Vaccine 60μg / Matrix-M2 50μg
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (50 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (60μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (50μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
GEN-003 Vaccine 60μg / Matrix-M2 75μg
GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
GEN-003 Vaccine (60μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (75μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GEN-003 Vaccine (30μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
GEN-003 Vaccine (60μg of each antigen)
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
Matrix-M2 Adjuvant (25μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (50μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 Adjuvant (75μg)
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
3. Willing and able to provide written informed consent.
4. Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
5. Men and women of childbearing potential, must be willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device (IUD), or barrier method (e.g., condom, diaphragm) for 28 days before and 90 days after receiving Study Drug.
Exclusion Criteria
2. Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
3. History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
4. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior to the first dose of Study Drug, any dose of corticosteroids within 30 days of the first dose of Study Drug, or high dose inhaled corticosteroids \[\> 960 μg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents.
5. Presence or history of autoimmune disease, regardless of current treatment.
6. Positive serologic test for Human Immunodeficiency Virus (HIV-1) or hepatitis C infection (in the absence of a negative PCR result); positive hepatitis B surface antigen (HBsAg) within 6 months prior to the first dose of Study Drug.
7. Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug.
8. Receipt of blood products within 90 days prior to the first dose of Study Drug.
9. Receipt of a live vaccine within 28 days prior to or a subunit vaccine within 14 days prior to the first dose of Study Drug or planned vaccination within 30 days following the last dose of Study Drug.
10. Pregnant or nursing women.
11. 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.
12. Other active, uncontrolled co-morbidities that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the study requirements.
NOTE: Subjects who are taking a medication to control an underlying co-morbidity may be enrolled if there have been no changes to their medication within 60 days prior to the first dose of Study Drug.
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genocea Biosciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States
Medical Center for Clinical Research
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Illinois Department of Medicine
Chicago, Illinois, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, United States
The Fenway Institute
Boston, Massachusetts, United States
UNC Global HIV Prevention and Treatment Clinical Trials Unit
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Westover Heights Clinic
Portland, Oregon, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Tekton Research
Austin, Texas, United States
Center for Clinical Studies - Houston
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, United States
University of Utah
Salt Lake City, Utah, United States
UW Virology Research Clinic
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GEN-003-002a
Identifier Type: -
Identifier Source: org_study_id