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

NCT ID: NCT01311674

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-03-11

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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Schedule 1- Standard dose primary vaccination series

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)

Group Type: ACTIVE_COMPARATOR

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL

Schedule 2 - High dose primary vaccination series

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)

Group Type: EXPERIMENTAL

hepatitis B vaccine

Intervention Type: BIOLOGICAL

Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL

Interventions

hepatitis B vaccine

Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL

Intervention Type: BIOLOGICAL

hepatitis B vaccine

Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL

Intervention Type: BIOLOGICAL

Other Intervention Names

Engerix-B; Engerix-B

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.

• 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.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Cangene Corporation

Gerald Winnan, MD

Role: PRINCIPAL_INVESTIGATOR

Cangene Corporation

Locations

Cangene Plasma Resources, Mid-Florida

Altamonte Springs, Florida, United States

Cangene Plasma Resources, Frederick

Frederick, Maryland, United States

Countries

United States

Other Identifiers

HB-012

Identifier Type: -

Identifier Source: org_study_id