Hepatitis BPhase 3NCT00440531

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

A Phase 3 study testing Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental) and Comparator: ENGERIX-B™ (currently licensed product) 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 determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™). 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?: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental) and Comparator: ENGERIX-B™ (currently licensed product)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 540 participants
Where: No sites listed yet
Study dates: Nov 2006to Nov 2007
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

Healthy male and female older adults greater than or equal to 50 years of age

Who cannot join

Any adult with a history of previous hepatitis B infection
A history of vaccination with any hepatitis B vaccine
Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine

Show all 11Show fewer

Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
Pregnant women, nursing mothers, and women planning to become pregnant within the study period
Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

About this study

Official title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Conditions: Hepatitis B
Being tested: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), Comparator: Modified Process Hepatitis B Vaccine (Experimental), Comparator: ENGERIX-B™ (currently licensed product)
Medical subject headings: Hepatitis B

What participants receive

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

Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)Biological
RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Comparator: Modified Process Hepatitis B Vaccine (Experimental)Biological
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Comparator: ENGERIX-B™ (currently licensed product)Biological
ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

Study groups in NCT00440531
Study group	Role	What they receive
1	Active comparator	RECOMBIVAX HB™ Receives: Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
2	Experimental	Modified Process Hepatitis B Vaccine Receives: Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
3	Active comparator	ENGERIX-B™ Receives: Biological: Comparator: ENGERIX-B™ (currently licensed product)

What is being measured

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

The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
Measured: 7 months (1 month after third vaccination)

Secondary outcomes (4)

The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).
Measured: 7 months (1 month after third vaccination)
The Total Number of Participants With One or More Injection-site Adverse Experiences
Measured: Days 1-5 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
Measured: Day 1-5 After Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Measured: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)

Timeline

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

Nov 2006Nov 2007

First posted27 Feb 2007 (estimated)
Study startNov 2006
Primary completionNov 2007
Study completionNov 2007

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00440531
Sponsor's protocol ID: V232-059
Other IDs: 2007_516
Status last verified: Mar 2017
First submitted: 26 Feb 2007
Last updated: 13 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.
PubMed 22185811

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

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
ClinicalTrials.gov ID: NCT00440531
Acronym / sponsor ID: V232-059
Conditions: Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 540 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 27 Feb 2007 (estimated)
Results: Posted 31 Mar 2009

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)RECOMBIVAX HB™
2	Experimental	Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)Modified Process Hepatitis B Vaccine
3	Active comparator	Biological: Comparator: ENGERIX-B™ (currently licensed product)ENGERIX-B™

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy male and female older adults greater than or equal to 50 years of age

Key exclusion criteria (11 listed)

Any adult with a history of previous hepatitis B infection
A history of vaccination with any hepatitis B vaccine
Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product

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
Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.	Biological	1
Comparator: Modified Process Hepatitis B Vaccine (Experimental)Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.	Biological	2
Comparator: ENGERIX-B™ (currently licensed product)ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.	Biological	3

Primary outcome

The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
Time frame: 7 months (1 month after third vaccination)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first vaccination) and at Month 7 (1 month after the third vaccination).

4 secondary outcomes

The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
Time frame: 7 months (1 month after third vaccination)
The Total Number of Participants With One or More Injection-site Adverse Experiences
Time frame: Days 1-5 After Any Vaccination
The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
Time frame: Day 1-5 After Vaccination
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Time frame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)

Results and safety

Results posted to the registry on 31 Mar 2009, 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	185	175
RECOMBIVAX-HB™	183	178
ENGERIX-B™	172	165

Primary outcome: The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)

Time frame: 7 months (1 month after third vaccination). Number. Unit: Participants

Measure	Modified Process Hepatitis B Vaccine n = 152	RECOMBIVAX-HB™ n = 147
Value	115	100

Modified Process Hepatitis B Vaccine: single-group percentage: 75.70 (95% CI 68 to 82.20)
RECOMBIVAX-HB™: single-group percentage: 68 (95% CI 59.80 to 75.50)

Population analysed: Per-protocol Population. The Per-protocol Population is defined as the participants that were able to complete the study as defined by the protocol.

4 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22185811Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 11 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 Apr 2017. 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 31 Mar 2009). 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?

The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) (time frame: 7 months (1 month after third vaccination)). 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 NCT00440531, 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 Apr 2017.