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

NCT01311674 | Terminated Phase 3 Results

• 1 other identifier: HB-012
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

Brief Summary

Hepatitis B Virus Antibody Booster Program

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Day 210

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

  up to Day 258

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

  0-12 months

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

  Up to Day 258

Study Arms (2)

Schedule 1- Standard dose primary vaccination series

ACTIVE COMPARATOR

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

Schedule 2 - High dose primary vaccination series

EXPERIMENTAL

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

Interventions

hepatitis B vaccine BIOLOGICAL

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

Also known as: Engerix-B

Schedule 1- Standard dose primary vaccination series

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Received parenteral immune globulin products or blood products (within 3 months before study entry)
• Past, present, or suspected IV drug use
• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (2)

Cangene Plasma Resources, Mid-Florida

Altamonte Springs, Florida, 32701, United States

Location

Cangene Plasma Resources, Frederick

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Interventions

Hepatitis B Vaccines; Engerix-B

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

This reporting only covers the interim analysis data collected within a 12 month period between enrolment of the first subject on 9 September 2009 and the interim analysis report cut off date of 1 September 2010.

Results Point of Contact

• Title: Christine Hall, Sr. Director Clinical Research
• Organization: Emergent Biosolutions

chall@ebsi.com

Study Officials

• Ronald Brown, MD

  Cangene Corporation

  PRINCIPAL INVESTIGATOR

• Gerald Winnan, MD

  Cangene Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 9, 2011
• Study Start: September 1, 2009
• Primary Completion: March 11, 2011
• Study Completion: March 11, 2011
• Last Updated: March 18, 2024
• Results First Posted: August 17, 2021

Record last verified: 2024-03

Locations

US (2)