Hepatitis BPhase 3NCT01251276

Hepatitis B Challenge Dose in Adults (V232-059-10)

A Phase 3 study testing Modified Process Hepatitis B Vaccine in people with Hepatitis B, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: Modified Process Hepatitis B Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: No sites listed yet
Study dates: 30 Nov 2010to 12 Apr 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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

In general good health based on a medical history.
Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Who cannot join

Known history of previous Hepatitis B infection.
History of vaccination with any Hepatitis B vaccine within the last 2 years.
History of febrile illness.
Known or suspected hypersensitivity to any component of HBVaxPro.
Receipt of medication / vaccine that may interfere with study assessments.
Known or suspected immune impairment.
Pregnant women and nursing mothers.

About this study

Official title: A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Conditions: Hepatitis B
Being tested: Modified Process Hepatitis B Vaccine
Medical subject headings: Hepatitis B

What participants receive

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

Modified Process Hepatitis B VaccineBiological
Also called HBVaxPro
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study

Study groups in NCT01251276
Study group	Role	What they receive
Modified Process Hepatitis B Vaccine in Base Study	Experimental	Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study Receives: Biological: Modified Process Hepatitis B Vaccine
ENGERIX-B™ Vaccine in Base Study	Experimental	Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study Receives: Biological: Modified Process Hepatitis B Vaccine

What is being measured

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

Percentage of Seroresponders Before and After the Challenge Vaccination
A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
Measured: Predose (Day 1) and 1 month after challenge dose (Month 1)

Secondary outcomes (5)

Percentage of Participants With One or More Adverse Experiences
An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.
Measured: Up to Day 15 after challenge dose
Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
The percentage of participants who discontinued the study due to an adverse experience was assessed.
Measured: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Experiences
The percentage of participants with one or more injection-site adverse experiences was assessed.
Measured: Up to Day 15 after challenge dose
Percentage of Participants With One or More Systemic Adverse Experiences
The percentage of participants with one or more systemic adverse experiences was assessed.
Measured: Up to Day 15 after challenge dose
Percentage of Participants With One or More Serious Adverse Experiences
A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.
Measured: Up to Month 1 after challenge dose

Timeline

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

30 Nov 201012 Apr 2011

First posted1 Dec 2010 (estimated)
Study start30 Nov 2010
Primary completion12 Apr 2011
Study completion12 Apr 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis BStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01251276
Sponsor's protocol ID: V232-059-10
Other IDs: rHB01C, 2006-003649-18
Status last verified: Aug 2022
First submitted: 23 Nov 2010
Last updated: 13 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
PubMed 25996838

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?

Official record

Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
ClinicalTrials.gov ID: NCT01251276
Acronym / sponsor ID: V232-059-10
Conditions: Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 Nov 2010 (actual)
Primary completion: 12 Apr 2011 (actual)
Study completion: 12 Apr 2011 (actual)
First posted: 1 Dec 2010 (estimated)
Results: Posted 28 Aug 2017

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Modified Process Hepatitis B Vaccine in Base Study	Experimental	Biological: Modified Process Hepatitis B VaccineParticipants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
ENGERIX-B™ Vaccine in Base Study	Experimental	Biological: Modified Process Hepatitis B VaccineParticipants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

In general good health based on a medical history.
Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Key exclusion criteria (7 listed)

Known history of previous Hepatitis B infection.
History of vaccination with any Hepatitis B vaccine within the last 2 years.
History of febrile illness.
Known or suspected hypersensitivity to any component of HBVaxPro.
Receipt of medication / vaccine that may interfere with study assessments.

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
Modified Process Hepatitis B VaccineAlso: HBVaxProModified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study	Biological	ENGERIX-B™ Vaccine in Base Study, Modified Process Hepatitis B Vaccine in Base Study

Primary outcome

Percentage of Seroresponders Before and After the Challenge Vaccination
Time frame: Predose (Day 1) and 1 month after challenge dose (Month 1)
A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.

5 secondary outcomes

Percentage of Participants With One or More Adverse Experiences
Time frame: Up to Day 15 after challenge dose
Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
Time frame: Up to Month 7
Percentage of Participants With One or More Injection-site Adverse Experiences
Time frame: Up to Day 15 after challenge dose
Percentage of Participants With One or More Systemic Adverse Experiences
Time frame: Up to Day 15 after challenge dose
Percentage of Participants With One or More Serious Adverse Experiences
Time frame: Up to Month 1 after challenge dose

Results and safety

Results posted to the registry on 28 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Modified Process Hepatitis B Vaccine in Base Study	96	95
ENGERIX-B™ Vaccine in Base Study	108	107

Primary outcome: Percentage of Seroresponders Before and After the Challenge Vaccination

Time frame: Predose (Day 1) and 1 month after challenge dose (Month 1). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Modified Process Hepatitis B Vaccine in Base Study n = 88	ENGERIX-B™ Vaccine in Base Study n = 103
Predose (Day 1); n=88, 102	45.5 (34.8 to 56.4)	58.8 (48.6 to 68.5)
Postdose (Month 1); n=88, 103	85.2 (76.1 to 91.9)	88.3 (80.5 to 93.8)

Population analysed: Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Modified Process Hepatitis B Vaccine in Base Study	0 of 96 (0%)	34 of 96 (35.4%)	Not reported
ENGERIX-B™ Vaccine in Base Study	1 of 107 (0.9%)	30 of 107 (28%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25996838Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis B

Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)
Chronic Hepatitis B Virus (HBV) Infection
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Recruiting
The Immune Responses After Hepatitis B Revaccination Doses in a Young Cohort
Hepatitis B, Vaccination; Infection

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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Modified Process Hepatitis B Vaccine in people with Hepatitis B, run by Merck Sharp & Dohme LLC.

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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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 28 Aug 2017). 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?

Percentage of Seroresponders Before and After the Challenge Vaccination (time frame: Predose (Day 1) and 1 month after challenge dose (Month 1)). 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 NCT01251276, which also lists 1 linked publication.

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 13 Sep 2022.