Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
1 other identifier
interventional
37
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
16 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
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 16, 2017
October 1, 2017
1.4 years
November 20, 2014
October 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact on clinical HSV-2 disease based on time to recurrence and lesion rate
53 weeks
Secondary Outcomes (1)
Number of patients with adverse events as a measure of safety and tolerability
57 weeks
Study Arms (6)
GEN-003 Vaccine 30μg / Matrix-M 25μg
EXPERIMENTALGEN-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 50μg
EXPERIMENTALGEN-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 75μg
EXPERIMENTALGEN-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 25μg
EXPERIMENTALGEN-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 50μg
EXPERIMENTALGEN-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
EXPERIMENTALGEN-003 Vaccine (60 μg of each antigen) with Matrix-M2 adjuvant (75 μg), administered as a 0.5 mL intramuscular (IM) injection.
Interventions
HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
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 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama Vaccine Research Unit
Birmingham, Alabama, 35294-0006, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Quest Clinical Research
San Francisco, California, 94115, United States
University of Illinois Department of Medicine
Chicago, Illinois, 60612, United States
Indiana University Infectious Disease Research
Indianapolis, Indiana, 46202, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
UNC Global HIV Prevention and Treatment Clinical Trials Unit
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Westover Heights Clinic
Portland, Oregon, 97210, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Tekton Research
Austin, Texas, 98745, United States
Center for Clinical Studies - Houston
Houston, Texas, 77030, United States
Center for Clinical Studies
Houston, Texas, 77065, United States
Center for Clinical Studies - Clear Lake/Webster
Webster, Texas, 77598, United States
University of Utah
Salt Lake City, Utah, 84132, United States
UW Virology Research Clinic
Seattle, Washington, 98104, United States
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
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
November 24, 2014
Study Start
January 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 16, 2017
Record last verified: 2017-10