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

Emergent BioSolutions

Status and phase: Terminated; Phase 3

Conditions: Healthy Volunteers

Treatments: Biological: hepatitis B vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01311674

HB-012

Details and patient eligibility

About

Hepatitis B Virus Antibody Booster Program

Full 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).

Enrollment: 141 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Schedule 1- Standard dose primary vaccination series

Active Comparator group

Description:

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)

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine

Schedule 2 - High dose primary vaccination series

Experimental group

Description:

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)

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine