Clinical trial NCT01311674: Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Official title: Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy Volunteers
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 141
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hepatitis B Virus Antibody Booster Program

Detailed description: 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).

Eligibility criteria: Inclusion Criteria

* Age 20-55 years.
* Naïve 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 exception:
* 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 B vaccination in the previous six months.
* History of hypersensitivity to yeast or any components 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.
* 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:
* RhoGAM (or equivalent anti-D immune globulin) within 6 weeks before study entry;
* Pertussis immune globulin: no exclusion
* Received parenteral immune globulin products or blood products (within 3 months before study entry)
* Past, present, or suspected IV drug use
* Positive HIV, HBV\* or HCV test result (\*except as described above in Inclusion Criteria)
* 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.

Primary outcomes:
measure: Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)
timeFrame: Day 0 to Day 210
Secondary outcomes:
measure: Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210
timeFrame: Day 210
measure: Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level
timeFrame: up to Day 258
measure: Time to Reach Anti-HBs Level of 80 IU/mL
timeFrame: 0-12 months
measure: Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer
timeFrame: Up to Day 258
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: Cangene Plasma Resources, Mid-Florida
state: Florida
city: Frederick
country: United States
facility: Cangene Plasma Resources, Frederick
state: Maryland
Study officials:
affiliation: Cangene Corporation
name: Ronald Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cangene Corporation
name: Gerald Winnan, MD
role: PRINCIPAL_INVESTIGATOR
References: