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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Cangene Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT01311674
First received: February 25, 2011
Last updated: March 8, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Healthy Volunteers
Biological: hepatitis B vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • anti-HBs antibody titers [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to peak anti-HBs titer [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
  • safety of hepatitis B booster vaccinations [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311674

Locations
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
Investigators
Principal Investigator: Ronald Brown, MD Cangene Corporation
Principal Investigator: Gerald Winnan, MD Cangene Corporation
  More Information

No publications provided

Responsible Party: Jodi Smith, Ph.D / Clinical Scientist, Cangene Corporation
ClinicalTrials.gov Identifier: NCT01311674     History of Changes
Other Study ID Numbers: HB-012
Study First Received: February 25, 2011
Last Updated: March 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Digestive System Diseases
DNA Virus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014