Healthy VolunteersPhase 3NCT01311674

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

A Phase 3 study testing hepatitis B vaccine in people with Healthy Volunteers, run by Emergent BioSolutions at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Hepatitis B Virus Antibody Booster Program Read more about this study

Who is it for?: Ages 20 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: hepatitis B vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 141 participants
Where: 2 sitesUnited States
Study dates: Sep 2009to 11 Mar 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 17Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Cangene Plasma Resources, Mid-Florida
Altamonte Springs, Florida, 32701
Cangene Plasma Resources, Frederick
Frederick, Maryland, 21702

Other trials in United States

About this study

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

Hepatitis B Virus Antibody Booster Program

Read the detailed 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).

Conditions: Healthy Volunteers
Being tested: hepatitis B vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hepatitis B vaccineBiological
Also called Engerix-B
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 vaccineBiological
Also called Engerix-B
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

Study groups in NCT01311674
Study group	Role	What they receive
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) Receives: Biological: hepatitis B vaccine
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) Receives: Biological: hepatitis B vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0 to Day 210

Secondary outcomes (4)

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.
Measured: Day 210
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.
Measured: 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.
Measured: 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.
Measured: Up to Day 258

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 200911 Mar 2011

First posted9 Mar 2011 (estimated)
Study startSep 2009
Primary completion11 Mar 2011
Study completion11 Mar 2011

Why it stopped: Prematurely terminated due to failure to meet study objectives.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01311674
Sponsor's protocol ID: HB-012
Status last verified: Mar 2024
First submitted: 25 Feb 2011
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hepatitis B Virus (HBV) Antibody (Anti-HBs) Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
ClinicalTrials.gov ID: NCT01311674
Acronym / sponsor ID: HB-012
Conditions: Healthy Volunteers
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Prematurely terminated due to failure to meet study objectives.
Enrolment: 141 participants (actual)
Lead sponsor: Emergent BioSolutionsIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: 11 Mar 2011 (actual)
Study completion: 11 Mar 2011 (actual)
First posted: 9 Mar 2011 (estimated)
Results: Posted 17 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hepatitis B Virus Antibody Booster Program

Detailed 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).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Schedule 1- Standard dose primary vaccination series	Active comparator	Biological: hepatitis B vaccineSchedule 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	Biological: hepatitis B vaccineSchedule 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)

Who may qualify

Ages: 20 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hepatitis B vaccineAlso: Engerix-BPrimary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL	Biological	Schedule 1- Standard dose primary vaccination series
hepatitis B vaccineAlso: Engerix-BPrimary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL	Biological	Schedule 2 - High dose primary vaccination series

Primary outcome

Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)
Time frame: Day 0 to Day 210
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.

4 secondary outcomes

Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210
Time frame: Day 210
Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level
Time frame: up to Day 258
Time to Reach Anti-HBs Level of 80 IU/mL
Time frame: 0-12 months
Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer
Time frame: Up to Day 258

Results and safety

Results posted to the registry on 17 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Schedule 1 - Standard Dose Primary Vaccination Series	72	28
Schedule 2 - High Dose Primary Vaccination Series	69	29

Primary outcome: Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)

Time frame: Day 0 to Day 210. Mean (Standard Deviation). Unit: IU*days/mL

Measure	Schedule 1- Standard Dose Primary Vaccination Series n = 28	Schedule 2 - High Dose Primary Vaccination Series n = 29
Value	1675.8 (3065.6)	4124.8 (1097.3)

Schedule 1- Standard Dose Primary Vaccination Series vs Schedule 2 - High Dose Primary Vaccination Series: p = 0.96, t-test, 2 sided

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Schedule 1- Standard Dose Primary Vaccination Series	1 of 72 (1.4%)	25 of 72 (34.7%)	0 of 72
Schedule 2 - High Dose Primary Vaccination Series	0 of 69 (0%)	37 of 69 (53.6%)	0 of 69

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Brown, MD principal investigator

Cangene Corporation

Gerald Winnan, MD principal investigator

Cangene Corporation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing hepatitis B vaccine in people with Healthy Volunteers, run by Emergent BioSolutions at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t) (time frame: Day 0 to Day 210). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01311674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.