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Prematurely terminated due to failure to meet study objectives.
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Hepatitis B Virus Antibody Booster Program
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Schedule 1- Standard dose primary vaccination series | Active Comparator | Schedule 1 subjects received 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) |
|
| Schedule 2 - High dose primary vaccination series | Experimental | Schedule 1 subjects received 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatitis B vaccine | Biological | Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Brown, MD | Cangene Corporation | Principal Investigator |
| Gerald Winnan, MD | Cangene Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cangene Plasma Resources, Mid-Florida | Altamonte Springs | Florida | 32701 | United States | ||
| Cangene Plasma Resources, Frederick |
This reporting only covers the interim analysis data collected within a 12 month period between enrolment of the first subject on 9 September 2009 and the interim analysis report cut off date of 1 September 2010 hence the enrollment number being less than the number of participants specified in the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Schedule 1 - Standard Dose Primary Vaccination Series | 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 every 4 months |
| FG001 | Schedule 2 - High Dose Primary Vaccination Series | 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 every 4 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Schedule 1- Standard Dose Primary Vaccination Series | Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The efficacy analysis population was used to assess the primary endpoint and to generate study conclusions. The efficacy analysis population included all subjects who were vaccinated prior to the interim analysis cut-off date of 1 September 2010 and assessed on visit Day 210. | Posted | Mean | Standard Deviation | IU*days/mL | Day 0 to Day 210 |
|
Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Schedule 1- Standard Dose Primary Vaccination Series | Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatomegaly and elevated liver enzymes | Hepatobiliary disorders | MedDRA Version 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EOSINOPHILIA | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
This reporting only covers the interim analysis data collected within a 12 month period between enrolment of the first subject on 9 September 2009 and the interim analysis report cut off date of 1 September 2010.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Hall, Sr. Director Clinical Research | Emergent Biosolutions | chall@ebsi.com |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| hepatitis B vaccine | Biological | 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 |
|
|
| 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 |
| 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 |
| 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 |
| Frederick |
| Maryland |
| 21702 |
| United States |
| BG001 | Schedule 2 - High Dose Primary Vaccination Series | Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Hepatitis B vaccination status at Baseline | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| Schedule 1- Standard Dose Primary Vaccination Series |
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 |
| OG001 | Schedule 2 - High Dose Primary Vaccination Series | Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 |
|
|
|
| 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. | The population used for this analysis, efficacy population responders, includes any subject who reached Day 210 (with the exception of subjects with all anti-HBs titer results < 2 IU/mL who were considered non-responders), 14 in Schedule 1 and 21 in Schedule 2. However, four subjects (1 in schedule 1 and 3 in schedule 2) were excluded due to missing day 210 titers. | Posted | Mean | Standard Deviation | IU/mL | 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. | The efficacy population responder subset was used. If a subject's anti-HBs titer levels did not reach 55 IU/mL on or before the cut-off date September 1, 2010, the subject was included as a censored observation. The last anti-HBs assessment date or interim analysis cut-off date, whichever was later, was used as the censoring date. In schedule 1, 3 subjects reached anti-HBs titer level of 55 IU/mL. In schedule 2, 4 subjects reached a titer of 55 IU/mL. | Posted | Median | 95% Confidence Interval | Days | 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. | The efficacy population responder subset was used. If a subject's anti-HBs titer levels did not reach 80 IU/mL on or before the cut-off date September 1, 2010, the subject was included as a censored observation. The last anti-HBs assessment date or interim analysis cut-off date, whichever was later, was used as the censoring date. In schedule 1, no subjects reached anti-HBs titer level of 80 IU/mL. In schedule 2, 2 subjects reached a titer of 80 IU/mL. | Posted | Median | 95% Confidence Interval | Days | 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. | The efficacy population responder subset was used. The interim analysis cut-off date was used as the censoring date, except in the case where the subject was lost to follow-up or withdrawn prior to the interim analysis cut off date. | Posted | Mean | Standard Deviation | days | Up to Day 258 |
|
|
|
|
| 0 |
| 72 |
| 1 |
| 72 |
| 25 |
| 72 |
| EG001 | Schedule 2 - High Dose Primary Vaccination Series | Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) 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 | 0 | 69 | 0 | 69 | 37 | 69 |
| HYPOCHROMIC ANAEMIA | Blood and lymphatic system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| CERUMEN IMPACTION | Ear and labyrinth disorders | MedDRA Version 13.0 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA Version 13.0 | Systematic Assessment |
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| CHEST DISCOMFORT | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| INFLUENZA LIKE ILLNESS | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| INJECTION SITE INFLAMMATION | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA Version 13.0 | Systematic Assessment |
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| HEPATITIS | Hepatobiliary disorders | MedDRA Version 13.0 | Systematic Assessment |
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| ALLERGY TO ANIMAL | Immune system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| MULTIPLE ALLERGIES | Immune system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| OTITIS EXTERNA | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| VIRAEMIA | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA Version 13.0 | Systematic Assessment |
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| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Systematic Assessment |
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| BLOOD GLUCOSE DECREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| BLOOD GLUCOSE INCREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
|
| CARBON DIOXIDE DECREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| EOSINOPHIL COUNT INCREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
|
| HEPATITIS B SURFACE ANTIGEN POSITIVE | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| HIV TEST NEGATIVE | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| NEUTROPHIL COUNT INCREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| TREPONEMA TEST FALSE POSITIVE | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| WHITE BLOOD CELL COUNT INCREASED | Investigations | MedDRA Version 13.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version 13.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| PRESYNCOPE | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| SINUS HEADACHE | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA Version 13.0 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| STRESS | Psychiatric disorders | MedDRA Version 13.0 | Systematic Assessment |
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| CHROMATURIA | Renal and urinary disorders | MedDRA Version 13.0 | Systematic Assessment |
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| URINARY TRACT PAIN | Renal and urinary disorders | MedDRA Version 13.0 | Systematic Assessment |
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| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA Version 13.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Systematic Assessment |
|
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| D045424 |
| Complex Mixtures |