Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Phase 3

Terminated

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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

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.

Arm && Interventions

Group	Intervention	Description
Schedule 2 - High dose primary vaccination series	hepatitis B vaccine	Schedule 1 subjects received 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)
Schedule 1- Standard dose primary vaccination series	hepatitis B vaccine	Schedule 1 subjects received 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination)

Primary Outcome Measures

Name	Time	Method
Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)	Day 0 to Day 210	The primary endpoint for study HB-012 is area under the anti-HBs antibody concentration-time curve (AUC0-t) through Day 210. This endpoint was chosen because it allowed for the assessment of changes in anti HBs antibody concentration over time, and addressed one of the study objectives: to determine the effectiveness of Engerix-B booster vaccinations in the production of high anti-HBs titer plasma. By comparing AUC0-t between the two dosing schedules, the primary endpoint of AUC0-t also addressed the study objective to determine the optimal vaccination schedule to obtain high anti-HBs titer plasma for the manufacture of HepaGam B.

Secondary Outcome Measures

Name	Time	Method
Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level	up to Day 258	Time to reach 55 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 55 IU/mL using Kaplan - Meier methods.
Time to Reach Anti-HBs Level of 80 IU/mL	0-12 months	Time to reach 80 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 80 IU/mL.
Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210	Day 210	Anti-HBs titers on Day 210 were assessed as a measure of the anti-HBs level attained following completion of the primary vaccination series; the final primary-series vaccination was administered for both Schedules on Day 180.
Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer	Up to Day 258	Time to reach peak anti-HBs plasma titer was calculated based on the actual times in days, from the baseline visit (Day 0) to the peak titer using Kaplan-Meier methods.

Locations (2): Cangene Plasma Resources, Mid-Florida
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Altamonte Springs, Florida, United States
Cangene Plasma Resources, Frederick
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Frederick, Maryland, United States