Status:
COMPLETED
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Lead Sponsor:
Genocea Biosciences, Inc.
Conditions:
Genital Herpes Simplex Type 2
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: * To ...
Eligibility Criteria
Inclusion
- Subjects who received placebo in GEN-003-002 and completed the study through Day 71 per protocol, including the collection of at least 45 anogenital swabs during Days 43 to 71.
- Enrolled into this trial within 56 days of completing Day 71 of GEN-003-002.
- Willing and able to provide written informed consent.
- Willing to perform and comply with all study procedures including attending clinic visits as scheduled.
- 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
- On suppressive antiviral medication within 7 days prior to the first dose of Study Drug.
- Collection of less than 45 anogenital swabs during Days 43 to 71 of the GEN-003-002 study.
- History of any form of ocular Herpes Simplex Virus (HSV) infection, HSV-related erythema multiforme, or herpes meningitis or encephalitis.
- 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.
- Presence or history of autoimmune disease, regardless of current treatment.
- 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.
- Clinically significant laboratory abnormality or a value ≥ Grade 2 within 56 days prior to the first dose of Study Drug.
- Receipt of blood products within 90 days prior to the first dose of Study Drug.
- 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.
- Pregnant or nursing women.
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02300142
Start Date
January 1 2015
End Date
June 1 2016
Last Update
October 16 2017
Active Locations (16)
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1
University of Alabama Vaccine Research Unit
Birmingham, Alabama, United States, 35294-0006
2
Medical Center for Clinical Research
San Diego, California, United States, 92108
3
Quest Clinical Research
San Francisco, California, United States, 94115
4
University of Illinois Department of Medicine
Chicago, Illinois, United States, 60612