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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01311674
• Other study ID #: HB-012
• Status: Terminated
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: March 11, 2011

Study information

• Verified date: March 2024
• Source: Emergent BioSolutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hepatitis B Virus Antibody Booster Program

Description:

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 141
• Est. completion date: March 11, 2011
• Est. primary completion date: March 11, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria:

• 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;

• Pertussis immune globulin: no exclusion

• Received parenteral immune globulin products or blood products (within 3 months before study entry)

• Past, present, or suspected IV drug use

• Positive HIV, HBV* or HCV test result (*except as described above in Inclusion Criteria)

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Hepatitis
• Hepatitis B

Intervention

Biological:
• hepatitis B vaccine
Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
• hepatitis B vaccine
Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL

Locations

Country	Name	City	State
United States	Cangene Plasma Resources, Mid-Florida	Altamonte Springs	Florida
United States	Cangene Plasma Resources, Frederick	Frederick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210	Anti-HBs titers on Day 210 were assessed as a measure of the anti-HBs level attained following completion of the primary vaccination series; the final primary-series vaccination was administered for both Schedules on Day 180.	Day 210
Secondary	Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level	Time to reach 55 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 55 IU/mL using Kaplan - Meier methods.	up to Day 258
Secondary	Time to Reach Anti-HBs Level of 80 IU/mL	Time to reach 80 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 80 IU/mL.	0-12 months
Secondary	Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer	Time to reach peak anti-HBs plasma titer was calculated based on the actual times in days, from the baseline visit (Day 0) to the peak titer using Kaplan-Meier methods.	Up to Day 258