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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01311674
Recruitment Status : Unknown
Verified March 2011 by Cangene Corporation.
Recruitment status was:  Active, not recruiting
First Posted : March 9, 2011
Last Update Posted : March 9, 2011
Information provided by:
Cangene Corporation

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: hepatitis B vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Study Start Date : September 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Schedule 1 Biological: hepatitis B vaccine
Primary vaccination series 20 ug/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 ug/1.0 mL
Other Name: Engerix-B

Experimental: Schedule 2 Biological: hepatitis B vaccine
Primary vaccination series 40 ug/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 ug/1.0 mL
Other Name: Engerix-B

Primary Outcome Measures :
  1. anti-HBs antibody titers [ Time Frame: up to 18 months ]

Secondary Outcome Measures :
  1. time to peak anti-HBs titer [ Time Frame: up to 18 months ]
  2. safety of hepatitis B booster vaccinations [ Time Frame: up to 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 20-55 years
  • Naive 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 exceptions.
  • 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 vaccination in the previous six months.
  • History of hypersensitivity to yeast or any component 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.
  • Subjects who have 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 (as specified by plasma center procedures):
  • Rho (D) immune globulin (e.g. RhoGAM or WinRho) within 6 weeks before study entry;
  • Pertussis immune globulin: no exclusion
  • Past, present, or suspected IV drug use
  • Positive HIV, HBV* or HCV test result (*except as described above in the Inclusion Criteria section)
  • Subjects with 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 (females must have a negative pregnancy test prior to each vaccination).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01311674

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United States, Florida
Cangene Plasma Resources, Mid-Florida
Altamonte Springs, Florida, United States, 32701
United States, Maryland
Cangene Plasma Resources, Frederick
Frederick, Maryland, United States, 21702
Sponsors and Collaborators
Cangene Corporation
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Principal Investigator: Ronald Brown, MD Cangene Corporation
Principal Investigator: Gerald Winnan, MD Cangene Corporation

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Responsible Party: Jodi Smith, Ph.D / Clinical Scientist, Cangene Corporation Identifier: NCT01311674     History of Changes
Other Study ID Numbers: HB-012
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: March 9, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs