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

Information source: Cangene Corporation
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: hepatitis B vaccine (Biological); hepatitis B vaccine (Biological)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Cangene Corporation

Official(s) and/or principal investigator(s):
Ronald Brown, MD, Principal Investigator, Affiliation: Cangene Corporation
Gerald Winnan, MD, Principal Investigator, Affiliation: Cangene Corporation

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: anti-HBs antibody titers

Secondary outcome:

time to peak anti-HBs titer

safety of hepatitis B booster vaccinations

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

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).

Locations and Contacts

Cangene Plasma Resources, Mid-Florida, Altamonte Springs, Florida 32701, United States

Cangene Plasma Resources, Frederick, Frederick, Maryland 21702, United States

Additional Information

Starting date: September 2009
Last updated: March 8, 2011

Page last updated: August 20, 2015

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