Hepatitis BPhase 3NCT01463683

Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

A Phase 3 study testing 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC and 2XP HEPTAVAX™-II IM 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

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults. Read more about this study

Who is it for?: Ages 20 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC and 2XP HEPTAVAX™-II IM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 722 participants
Where: No sites listed yet
Study dates: 29 Nov 2011to 6 Nov 2012
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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

To receive the first study vaccination, Participants should meet all inclusion criteria.
Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main trial without participating in Future Biomedical Research.
Participant is Japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
Participant is determined to be in general good health based on the medical history taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying chronic illness must be documented to be in stable condition.
For females, a negative urine pregnancy test just prior to vaccination on Day 1.

Who cannot join

To receive the first study vaccination, Participants should not have any exclusion criteria. For items with an asterisk (), if the Participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.
Participant has a history of previous hepatitis B infection.
Participant has a history of vaccination with any hepatitis B vaccine.
*Participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥ 37.8°C).
Participant has a known or suspected hypersensitivity to any component of HEPTAVAX™-II vaccine and latex (e.g., aluminum, yeast).
Participant has a 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, or is expected to require such blood-derived products during the study.

Show all 13Show fewer

*Participant has received licensed inactivated vaccines within 14 days prior or licensed live vaccines within 28 days prior to first injection with the study vaccine.
Participant has received investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
Use of immunosuppressive therapy. Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to enrollment until 6 weeks post vaccination, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) per day for >2 weeks (except for use of topical or inhalation steroid therapy).
Pregnant women, nursing mothers, and women planning to become pregnant within the study period. Women of childbearing age should employ an acceptable method of contraception during the study (e.g., condom, diaphragm, oral contraceptive, Intrauterine Device (IUD), or hormonal implants are considered acceptable).
Participant has any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Participant has a coagulation disorder contraindicating intramuscular injection.
Participant has immunocompromised condition (such as Human Immunodeficiency Virus (HIV) positive, leukemia, lymphoma, other cancers or disorders).

About this study

Official title: A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Read the detailed description

2XP HEPTAVAX™-II is manufactured using a modified process in which the composition of the amorphous aluminum hydroxyphosphate sulfate adjuvant has been modified by increasing the phosphate content by approximately 2-fold. Thus the modified process HEPTAVAX™-II is referred to as 2XP HEPTAVAX™-II.

Conditions: Hepatitis B
Being tested: 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC, 2XP HEPTAVAX™-II IM
Medical subject headings: Hepatitis B

What participants receive

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

2XP HEPTAVAX™-II SCBiological
Also called RECOMBIVAX HB, HBVAXPRO
1XP HEPTAVAX™-II SCBiological
Also called RECOMBIVAX HB, HBVAXPRO
2XP HEPTAVAX™-II IMBiological

Study groups in NCT01463683
Study group	Role	What they receive
V232-2XP SC	Experimental	2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 Receives: Biological: 2XP HEPTAVAX™-II SC
V232-1XP SC	Active comparator	1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6 Receives: Biological: 1XP HEPTAVAX™-II SC
V232-2XP IM	Experimental	2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6 Receives: Biological: 2XP HEPTAVAX™-II IM

What is being measured

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

Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection
Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.
Measured: Month 7
Percentage of Participants With Injection-site Adverse Events
Participants were evaluated for injection-site adverse events using MedDRA version 15.1
Measured: Up to 15 days after each vaccination
Percentage of Participants With Pyrexia Adverse Events
Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).
Measured: Up to 15 days after each vaccination

Timeline

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

29 Nov 20116 Nov 2012

First posted2 Nov 2011 (estimated)
Study start29 Nov 2011
Primary completion6 Nov 2012
Study completion6 Nov 2012

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: 722 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01463683
Sponsor's protocol ID: V232-062
Status last verified: Jun 2018
First submitted: 28 Oct 2011
Last updated: 18 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

Publications

Kishino H, Takahashi K, Sawata M, Tanaka Y. Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young Japanese adults. Hum Vaccin Immunother. 2018 Jul 3;14(7):1773-1778. doi: 10.1080/21645515.2018.1452578. Epub 2018 Apr 12.
PubMed 29553862

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 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process
ClinicalTrials.gov ID: NCT01463683
Acronym / sponsor ID: V232-062
Conditions: Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 722 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 29 Nov 2011 (actual)
Primary completion: 6 Nov 2012 (actual)
Study completion: 6 Nov 2012 (actual)
First posted: 2 Nov 2011 (estimated)
Results: Posted 17 Feb 2014

Clinical summary

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

This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.

Detailed description

Study design

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

Arm	Type	Receives
V232-2XP SC	Experimental	Biological: 2XP HEPTAVAX™-II SC2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
V232-1XP SC	Active comparator	Biological: 1XP HEPTAVAX™-II SC1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
V232-2XP IM	Experimental	Biological: 2XP HEPTAVAX™-II IM2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 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 (5 listed)

To receive the first study vaccination, Participants should meet all inclusion criteria.
Participants provide written informed consent for the trial. The Participant may also provide consent for Future Biomedical Research. However, the Participant may participate in the main trial without participating in Future Biomedical Research.
Participant is Japanese male or female, between 20 to 35 years of age on the day of the first study vaccination.
Participant is determined to be in general good health based on the medical history taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying chronic illness must be documented to be in stable condition.
For females, a negative urine pregnancy test just prior to vaccination on Day 1.

Key exclusion criteria (13 listed)

To receive the first study vaccination, Participants should not have any exclusion criteria. For items with an asterisk (), if the Participant meets these exclusion criteria, the visit may be rescheduled for a time when these criteria are not met.
Participant has a history of previous hepatitis B infection.
Participant has a history of vaccination with any hepatitis B vaccine.
*Participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥ 37.8°C).
Participant has a known or suspected hypersensitivity to any component of HEPTAVAX™-II vaccine and latex (e.g., aluminum, yeast).

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
2XP HEPTAVAX™-II SCAlso: RECOMBIVAX HB, HBVAXPRO	Biological	V232-2XP SC
1XP HEPTAVAX™-II SCAlso: RECOMBIVAX HB, HBVAXPRO	Biological	V232-1XP SC
2XP HEPTAVAX™-II IM	Biological	V232-2XP IM

Primary outcome

Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection
Time frame: Month 7
Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.
Percentage of Participants With Injection-site Adverse Events
Time frame: Up to 15 days after each vaccination
Participants were evaluated for injection-site adverse events using MedDRA version 15.1
Percentage of Participants With Pyrexia Adverse Events
Time frame: Up to 15 days after each vaccination
Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).

Results and safety

Results posted to the registry on 17 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V232-2XP Subcutaneous (SC)	309	290
V232-1XP SC	309	278
V232-2XP Intramuscular (IM)	104	93

Primary outcome: Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection

Time frame: Month 7. Number. Unit: Percentage of participants

Measure	V232-2XP SC n = 247	V232-1XP SC n = 217
Value	90.1	82.5

V232-2XP SC vs V232-1XP SC: Difference in percentage of participants: 7.6 (95% CI 1.9 to 13.6), Miettinen & Nurminen

Population analysed: The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.

Primary outcome: Percentage of Participants With Injection-site Adverse Events

Time frame: Up to 15 days after each vaccination. Number. Unit: Percentage of participants

Measure	V232-2XP SC n = 309	V232-1XP SC n = 308	V232-2XP IM n = 104
Value	76.4	71.4	65.4

V232-2XP SC vs V232-1XP SC: Difference in percentage of participants: 4.9 (95% CI -2.0 to 11.9), p = 0.162, Miettinen & Nurminen
V232-2XP SC vs V232-2XP IM: Difference in percentage of participants: 11.0 (95% CI 1.1 to 21.6), p = 0.028, Miettinen & Nurminen
V232-1XP SC vs V232-2XP IM: Difference in percentage of participants: 6.0 (95% CI -4.0 to 16.8), p = 0.246, Miettinen & Nurminen

Population analysed: All randomized participants who received at least 1 vaccination were included in the analysis

Primary outcome: Percentage of Participants With Pyrexia Adverse Events

Time frame: Up to 15 days after each vaccination. Number. Unit: Percentage of participants

Measure	V232-2XP SC n = 309	V232-1XP SC n = 308	V232-2XP IM n = 104
Value	3.2	3.9	4.8

V232-2XP SC vs V232-1XP SC: Difference in percentage of participants: -0.7 (95% CI -3.8 to 2.4), p = 0.659, Miettinen & Nurminen
V232-2XP SC vs V232-2XP IM: Difference in percentage of participants: -1.6 (95% CI -7.7 to 2.2), p = 0.459, Miettinen & Nurminen
V232-1XP SC vs V232-2XP IM: Difference in percentage of participants: -0.9 (95% CI -7.1 to 3.0), p = 0.686, Miettinen & Nurminen

Population analysed: All randomized participants who received at least 1 vaccination were included in the analysis

Adverse events

Time frame: Serious adverse events: up to Month 7; non-serious adverse events: up to 14 days after each vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V232-2XP SC	1 of 309 (0.3%)	239 of 309 (77.3%)	Not reported
V232-1XP SC	2 of 308 (0.6%)	225 of 308 (73.1%)	Not reported
V232-2XP IM	0 of 104 (0%)	69 of 104 (66.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29553862Kishino H, Takahashi K, Sawata M, Tanaka Y. Immunogenicity, safety, and tolerability of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young Japanese adults. Hum Vaccin Immunother. 2018 Jul 3;14(7):1773-1778. doi: 10.1080/21645515.2018.1452578. Epub 2018 Apr 12.
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

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
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Active, not recruitingPhase 2
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Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2XP HEPTAVAX™-II SC, 1XP HEPTAVAX™-II SC and 2XP HEPTAVAX™-II IM 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 5 inclusion and 13 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 18 Jul 2018. 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 17 Feb 2014). 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 Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection (time frame: Month 7). The study lists 3 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 NCT01463683, 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 18 Jul 2018.