Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Information source: Cangene Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: hepatitis B vaccine (Biological); hepatitis B vaccine (Biological)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Cangene Corporation Official(s) and/or principal investigator(s): Ronald Brown, MD, Principal Investigator, Affiliation: Cangene Corporation Gerald Winnan, MD, Principal Investigator, Affiliation: Cangene Corporation
Summary
The purpose of this study is to vaccinate plasmapheresis donors for collection of high titer
plasma to be used in the manufacture of Hepatitis B Immune Globulin (HBIG).
Clinical Details
Official title: Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: anti-HBs antibody titers
Secondary outcome: time to peak anti-HBs titersafety of hepatitis B booster vaccinations
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 20-55 years
- Naive or previously hepatitis B-vaccinated males or females
- Normal and healthy as determined by medical history, physical exam, vital signs and
clinical laboratory tests
- Subject must meet all required/recommended subject suitability criteria that pertain
to normal source plasma donors with the following exceptions.
- Subjects who previously tested positive for HBsAg may be accepted into the anti-HBs
program provided they now test negative and meet all other normal donor suitability
criteria.
- Written informed consent.
Exclusion Criteria:
- Subjects who have received a hepatitis vaccination in the previous six months.
- History of hypersensitivity to yeast or any component of the Engerix-B® vaccine.
- History of hypersensitivity to any hepatitis B-containing vaccine.
- Use of any investigational product within the past 30 days or during the course of
the study.
- Use of steroids or immunosuppressives during the study period.
- Subjects who have received immunosuppressive therapy (including systemic steroids)
within 30 days before study entry
- Subjects who have received cytotoxic therapy (in the previous 5 years prior to study
entry)
- Received parenteral immune globulin products or blood products within 3 months before
study entry with the following exceptions (as specified by plasma center procedures):
- Rho (D) immune globulin (e. g. RhoGAM or WinRho) within 6 weeks before study entry;
- Pertussis immune globulin: no exclusion
- Past, present, or suspected IV drug use
- Positive HIV, HBV* or HCV test result (*except as described above in the Inclusion
Criteria section)
- Subjects with autoimmune disease (such as, but not limited to demyelinating disease)
- Subjects with cancer, heart disease (including hospitalization for myocardial
infarction, arrhythmia, syncope, congestive heart failure), uncontrolled
hypertension, uncontrolled insulin-dependent diabetes mellitus, seizures, kidney
disease
- Severely or morbidly obese, or higher obesity classification, which corresponds to
BMI of 35 or higher
- Pregnancy or lactation (females must have a negative pregnancy test prior to each
vaccination).
Locations and Contacts
Cangene Plasma Resources, Mid-Florida, Altamonte Springs, Florida 32701, United States
Cangene Plasma Resources, Frederick, Frederick, Maryland 21702, United States
Additional Information
Starting date: September 2009
Last updated: March 8, 2011
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