Hepatitis B InfectionPhase 3NCT00489099

A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

A Phase 3 study testing V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B and V232 Modified Process Hepatitis B Vaccine: Lot C in people with Hepatitis B Infection, 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

Who is it for?: Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B Infection
What is being tested?: V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B and V232 Modified Process Hepatitis B Vaccine: Lot C
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 860 participants
Where: No sites listed yet
Study dates: Jun 2005to May 2006
Phase: Phase 3
Are there results?: None posted in the registry

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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

In general good health
Female participants have a negative pregnancy test just prior to vaccination on Day 1

Who cannot join

History of Hepatitis B Infection or vaccination
Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
Participation on prior study using an investigational drug or vaccine in prior 3 months
Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
Pregnant or nursing women or women planning to become pregnant within the study period

About this study

Official title: A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Conditions: Hepatitis B Infection
Being tested: V232 Modified Process Hepatitis B Vaccine: Lot A, V232 Modified Process Hepatitis B Vaccine: Lot B, V232 Modified Process Hepatitis B Vaccine: Lot C, V232 Current 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.

V232 Modified Process Hepatitis B Vaccine: Lot ABiological
V232 Modified Process Hepatitis B Vaccine: Lot BBiological
V232 Modified Process Hepatitis B Vaccine: Lot CBiological
V232 Current Process Hepatitis B VaccineBiological

Study groups in NCT00489099
Study group	Role	What they receive
V232 Modified Process Hepatitis B Vaccine: Lot A	Experimental	Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. Receives: Biological: V232 Modified Process Hepatitis B Vaccine: Lot A
V232 Modified Process Hepatitis B Vaccine: Lot B	Experimental	Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. Receives: Biological: V232 Modified Process Hepatitis B Vaccine: Lot B
V232 Modified Process Hepatitis B Vaccine: Lot C	Experimental	Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. Receives: Biological: V232 Modified Process Hepatitis B Vaccine: Lot C
V232 Current Process Hepatitis B Vaccine	Active comparator	Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6. Receives: Biological: V232 Current Process Hepatitis B Vaccine

What is being measured

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

Number of Participants with Seroprotection to Hepatitis B Surface Antigen
Measured: 1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
Measured: 1 month after the third vaccination (Month 7)

Secondary outcomes (4)

Percentage of Participants with an Adverse Experience
Measured: Up to 15 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience
Measured: Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience
Measured: Up to 15 days after any vaccination
Percentage of Participants with Fever (>=37.8°C, 100.0°F)
Measured: Up to 5 days after any vaccination

Timeline

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

Jun 2005May 2006

First posted21 Jun 2007 (estimated)
Study startJun 2005
Primary completionMay 2006
Study completionMay 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis B InfectionStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 860 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00489099
Sponsor's protocol ID: V232-054
Other IDs: 2007_565
Status last verified: Mar 2017
First submitted: 20 Jun 2007
Last updated: 16 Mar 2017
Results posted: No
Data monitoring committee: No

Publications

Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. doi: 10.4161/hv.5.2.6587. Epub 2009 Feb 14.
PubMed 18690015

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
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b

All Hepatitis B Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
ClinicalTrials.gov ID: NCT00489099
Acronym / sponsor ID: V232-054
Conditions: Hepatitis B Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 860 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 21 Jun 2007 (estimated)
Results: Not posted in the source record

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
V232 Modified Process Hepatitis B Vaccine: Lot A	Experimental	Biological: V232 Modified Process Hepatitis B Vaccine: Lot ARecombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot B	Experimental	Biological: V232 Modified Process Hepatitis B Vaccine: Lot BRecombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Modified Process Hepatitis B Vaccine: Lot C	Experimental	Biological: V232 Modified Process Hepatitis B Vaccine: Lot CRecombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
V232 Current Process Hepatitis B Vaccine	Active comparator	Biological: V232 Current Process Hepatitis B VaccineRecombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Who may qualify

Ages: 20 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

In general good health
Female participants have a negative pregnancy test just prior to vaccination on Day 1

Key exclusion criteria (7 listed)

History of Hepatitis B Infection or vaccination
Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
Participation on prior study using an investigational drug or vaccine in prior 3 months

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
V232 Modified Process Hepatitis B Vaccine: Lot A	Biological	V232 Modified Process Hepatitis B Vaccine: Lot A
V232 Modified Process Hepatitis B Vaccine: Lot B	Biological	V232 Modified Process Hepatitis B Vaccine: Lot B
V232 Modified Process Hepatitis B Vaccine: Lot C	Biological	V232 Modified Process Hepatitis B Vaccine: Lot C
V232 Current Process Hepatitis B Vaccine	Biological	V232 Current Process Hepatitis B Vaccine

Primary outcome

Number of Participants with Seroprotection to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen
Time frame: 1 month after the third vaccination (Month 7)

4 secondary outcomes

Percentage of Participants with an Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience
Time frame: Up to 15 days after any vaccination
Percentage of Participants with Fever (>=37.8°C, 100.0°F)
Time frame: Up to 5 days after any vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Background: PubMed 18690015Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. doi: 10.4161/hv.5.2.6587. Epub 2009 Feb 14.

Related trials for Hepatitis B Infection

Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
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 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 16 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants with Seroprotection to Hepatitis B Surface Antigen (time frame: 1 month after the third vaccination (Month 7)). The study lists 2 primary outcomes in all. 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 NCT00489099, 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 16 Mar 2017.