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

Primary Purpose

Healthy Volunteers

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

hepatitis B vaccine

About this trial

This is an interventional other trial for Healthy Volunteers

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cangene Plasma Resources, Mid-Florida
Cangene Plasma Resources, Frederick

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Schedule 1- Standard dose primary vaccination series

Schedule 2 - High dose primary vaccination series

Arm 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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01311674

First Posted

February 25, 2011

Last Updated

July 26, 2021

Sponsor

Emergent BioSolutions

1. Study Identification

Unique Protocol Identification Number

NCT01311674

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Prematurely terminated due to failure to meet study objectives.

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 11, 2011 (Actual)

Study Completion Date

March 11, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Emergent BioSolutions

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

141 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Schedule 1- Standard dose primary vaccination series

Arm Type

Active Comparator

Arm 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)

Arm Title

Schedule 2 - High dose primary vaccination series

Arm Type

Experimental

Arm 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)

Intervention Type

Biological

Intervention Name(s)

hepatitis B vaccine

Other Intervention Name(s)

Engerix-B

Intervention Description

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

Intervention Name(s)

hepatitis B vaccine

Other Intervention Name(s)

Engerix-B

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)

Description

Time Frame

Day 0 to Day 210

Secondary Outcome Measure Information:

Title

Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210

Description

Time Frame

Day 210

Title

Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level

Description

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 Frame

up to Day 258

Title

Time to Reach Anti-HBs Level of 80 IU/mL

Description

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.

Time Frame

0-12 months

Title

Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer

Description

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.

Time Frame

Up to Day 258

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Brown, MD

Organizational Affiliation

Cangene Corporation

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gerald Winnan, MD

Organizational Affiliation

Cangene Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cangene Plasma Resources, Mid-Florida

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

Cangene Plasma Resources, Frederick

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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