Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
- Conditions
- Genital Herpes Simplex Type 2
- Interventions
- Biological: GEN-003 Vaccine (30μg of each antigen)Biological: GEN-003 Vaccine (60μg of each antigen)Biological: Matrix-M2 Adjuvant (25μg)Biological: Matrix-M2 Adjuvant (75μg)Biological: Matrix-M2 Adjuvant (50μg)
- Registration Number
- NCT02300142
- Lead Sponsor
- Genocea Biosciences, Inc.
- 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 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description GEN-003 Vaccine 30μg / Matrix-M 25μg Matrix-M2 Adjuvant (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 / Matrix-M 25μg GEN-003 Vaccine (30μg of each antigen) 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 / Matrix-M2 75μg GEN-003 Vaccine (30μg of each antigen) 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 / Matrix-M2 75μg Matrix-M2 Adjuvant (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 60μg / Matrix-M2 50μg GEN-003 Vaccine (60μg of each antigen) 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 / Matrix-M2 25μg GEN-003 Vaccine (60μg of each antigen) 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 / Matrix-M2 25μg Matrix-M2 Adjuvant (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 / Matrix-M2 75μg Matrix-M2 Adjuvant (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 30μg / Matrix-M2 50μg GEN-003 Vaccine (30μg of each antigen) 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 / Matrix-M2 50μg Matrix-M2 Adjuvant (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 60μg / Matrix-M2 50μg Matrix-M2 Adjuvant (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 / Matrix-M2 75μg GEN-003 Vaccine (60μg of each antigen) GEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
- Primary Outcome Measures
Name Time Method Impact on clinical HSV-2 disease based on time to recurrence and lesion rate 53 weeks
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events as a measure of safety and tolerability 57 weeks
Trial Locations
- Locations (16)
Tekton Research
🇺🇸Austin, Texas, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
Center for Clinical Studies - Clear Lake/Webster
🇺🇸Webster, Texas, United States
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
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Indiana University Infectious Disease Research
🇺🇸Indianapolis, Indiana, United States
The Fenway Institute
🇺🇸Boston, Massachusetts, United States
Westover Heights Clinic
🇺🇸Portland, Oregon, United States
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Center for Clinical Studies - Houston
🇺🇸Houston, Texas, United States
UW Virology Research Clinic
🇺🇸Seattle, Washington, United States
UNC Global HIV Prevention and Treatment Clinical Trials Unit
🇺🇸Chapel Hill, North Carolina, United States