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

Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Hepatitis B Virus Antibody Booster Program

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: hepatitis B vaccine; Biological: hepatitis B vaccine

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).

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Cangene Plasma Resources, Mid-Florida
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Cangene Plasma Resources, Frederick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Biological: 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; Other Names: Engerix-B; 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; Other Names: Engerix-B
Experimental: 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)	Biological: 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; Other Names: Engerix-B; 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; Other Names: Engerix-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)	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.	Day 0 to Day 210

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Between Vaccination Schedules Using Anti-HBs Titers on 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.	Day 210
Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level	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.	up to Day 258
Time to Reach Anti-HBs Level of 80 IU/mL	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.	0-12 months
Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer	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.	Up to Day 258

Collaborators and Investigators

• Sponsor: Emergent BioSolutions
• Investigators: Principal Investigator: Ronald Brown, MD, Cangene Corporation; Principal Investigator: Gerald Winnan, MD, Cangene Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 11, 2011
• Study Completion (Actual): March 11, 2011

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimated): March 9, 2011

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis B; Hepatitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: HB-012