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

Hepatitis B Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490499
• Other study ID #: V419-013
• Secondary ID: V419-0132020-000
• Status: Completed
• Phase: Phase 3
• Start date: September 2, 2020
• Est. completion date: December 29, 2020

Study information

• Verified date: July 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• HBVAXPRO™
Single 0.5 mL intramuscular dose

Locations

Country	Name	City	State
Finland	Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)	Espoo	Uusimaa
Finland	Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)	Helsinki	Uusimaa
Finland	Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)	Helsinki	Uusimaa
Finland	Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)	Jarvenpaa	Uusimaa
Finland	Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)	Kokkola	Mellersta Osterbotten
Finland	Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)	Oulu	Pohjois-Pohjanmaa
Finland	Porin rokotetutkimusklinikka ( Site 0008)	Pori	Satakunta
Finland	Seinajoki Vaccine Research Center ( Site 0010)	Seinajoki	Pohjanmaa
Finland	Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)	Tampere	Pirkanmaa
Finland	Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)	Turku	Varsinais-Suomi

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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 Jun 2:2073 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 30
Secondary	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.	Day 1 and Day 30