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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
HBVAXPRO™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
  • Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
  • Seinajoki Vaccine Research Center ( Site 0010)
  • Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
  • Porin rokotetutkimusklinikka ( Site 0008)
  • Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
  • Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
  • Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
  • Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
  • Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HBVAXPRO™

Arm Description

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™).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2020
Last Updated
July 20, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04490499
Brief Title
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
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®
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 29, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBVAXPRO™
Arm Type
Experimental
Arm Description
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™).
Intervention Type
Biological
Intervention Name(s)
HBVAXPRO™
Other Intervention Name(s)
Hepatitis B virus (HBV) vaccine; V232
Intervention Description
Single 0.5 mL intramuscular dose
Primary Outcome Measure Information:
Title
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™
Description
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.
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Description
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.
Time Frame
Day 1 and Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
City
Kokkola
State/Province
Mellersta Osterbotten
ZIP/Postal Code
67100
Country
Finland
Facility Name
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Facility Name
Seinajoki Vaccine Research Center ( Site 0010)
City
Seinajoki
State/Province
Pohjanmaa
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
City
Oulu
State/Province
Pohjois-Pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Facility Name
Porin rokotetutkimusklinikka ( Site 0008)
City
Pori
State/Province
Satakunta
ZIP/Postal Code
28100
Country
Finland
Facility Name
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
City
Espoo
State/Province
Uusimaa
ZIP/Postal Code
02230
Country
Finland
Facility Name
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00100
Country
Finland
Facility Name
Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00930
Country
Finland
Facility Name
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
City
Jarvenpaa
State/Province
Uusimaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35653552
Citation
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.
Results Reference
result

Learn more about this trial

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

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