Hepatitis BPhase 3NCT04490499

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)

A Phase 3 study testing HBVAXPRO™ in people with Hepatitis B, run by Merck Sharp & Dohme LLC at 10 sites in Finland.

Completed

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

Trial summary

The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed. Read more about this study

Who is it for?: Ages 8 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B
What is being tested?: HBVAXPRO™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 10 sitesFinland
Study dates: 2 Sep 2020to 29 Dec 2020
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 8 to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.

Who cannot join

Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
Has a known hypersensitivity to any component of the study vaccine.
Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
Has a bleeding disorder contraindicating intramuscular vaccinations.
Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Finland10 sites

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
Espoo, Uusimaa, 02230
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
Helsinki, Uusimaa, 00100
Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
Helsinki, Uusimaa, 00930
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
Jarvenpaa, Uusimaa, 04400
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
Kokkola, Keski-Pohjanmaa, 67100
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, North Ostrobothnia, 90220
Porin rokotetutkimusklinikka ( Site 0008)
Pori, Satakunta, 28100
Seinajoki Vaccine Research Center ( Site 0010)
Seinajoki, Pohjanmaa, 60100
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, Pirkanmaa, 33100
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
Turku, Southwest Finland, 20520

Other trials in Finland

About this study

Official title: A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®

Conditions: Hepatitis B
Being tested: HBVAXPRO™
Medical subject headings: Hepatitis B

What participants receive

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

HBVAXPRO™Biological
Also called Hepatitis B virus (HBV) vaccine; V232
Single 0.5 mL intramuscular dose

Study groups in NCT04490499
Study group	Role	What they receive
HBVAXPRO™	Experimental	Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). Receives: Biological: HBVAXPRO™

What is being measured

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

Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
Measured: Day 30

Secondary outcomes (1)

Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL.
Measured: Day 1 and Day 30

Timeline

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

2 Sep 202029 Dec 2020

First posted29 Jul 2020
Study start2 Sep 2020
Primary completion29 Dec 2020
Study completion29 Dec 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04490499
Sponsor's protocol ID: V419-013
Other IDs: V419-013, 2020-000126-26
Status last verified: Jul 2022
First submitted: 28 Jul 2020
Last updated: 27 Jul 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

Ahonen A, Zhang Y, Marcek T, Lumley J, Johnson DR, Guris D, Wilck MB. Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073747. doi: 10.1080/21645515.2022.2073747. Epub 2022 Jun 2.
PubMed 35653552

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

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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®
ClinicalTrials.gov ID: NCT04490499
Acronym / sponsor ID: V419-013
Conditions: Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 2 Sep 2020 (actual)
Primary completion: 29 Dec 2020 (actual)
Study completion: 29 Dec 2020 (actual)
First posted: 29 Jul 2020 (actual)
Results: Posted 5 Sep 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
HBVAXPRO™	Experimental	Biological: HBVAXPRO™Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

Who may qualify

Ages: 8 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.

Key exclusion criteria (7 listed)

Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
Has a known hypersensitivity to any component of the study vaccine.
Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
Has a bleeding disorder contraindicating intramuscular vaccinations.

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
HBVAXPRO™Also: Hepatitis B virus (HBV) vaccine; V232Single 0.5 mL intramuscular dose	Biological	HBVAXPRO™

Primary outcome

Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™
Time frame: Day 30
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.

1 secondary outcome

Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Time frame: Day 1 and Day 30

Results and safety

Results posted to the registry on 5 Sep 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
HBVAXPRO™	207	205

Primary outcome: Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™

Time frame: Day 30. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	HBVAXPRO™ n = 202
Value	99.5 (97.3)

Population analysed: The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HBVAXPRO™	0 of 205 (0%)	0 of 205 (0%)	0 of 207

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35653552Ahonen A, Zhang Y, Marcek T, Lumley J, Johnson DR, Guris D, Wilck MB. Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073747. doi: 10.1080/21645515.2022.2073747. Epub 2022 Jun 2.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.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
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 Director study director

Merck Sharp & Dohme LLC

10 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 HBVAXPRO™ in people with Hepatitis B, run by Merck Sharp & Dohme LLC at 10 sites in Finland.

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 3 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Finland. 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 5 Sep 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?

Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™ (time frame: Day 30). 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 NCT04490499, 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 27 Jul 2022.