This trial is active, not recruiting.

Condition healthy volunteers
Treatments hepatitis b vaccine
Phase phase 4
Sponsor Cangene Corporation
Start date September 2009
End date June 2011
Trial size 1000 participants
Trial identifier NCT01311674, HB-012


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
(Active Comparator)
hepatitis b vaccine Engerix-B
Primary vaccination series 20 ug/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 ug/1.0 mL
hepatitis b vaccine Engerix-B
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

Primary Outcomes

anti-HBs antibody titers
time frame: up to 18 months

Secondary Outcomes

time to peak anti-HBs titer
time frame: up to 18 months
safety of hepatitis B booster vaccinations
time frame: up to 18 months

Eligibility Criteria

Male or female participants from 20 years up to 55 years old.

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).

Additional Information

Official title Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Principal investigator Ronald Brown, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Cangene Corporation.