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

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: HBVAXPRO™

• Registration Number: NCT04490499
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Study Start: 2020-09-02
• Primary Completion: 2020-12-29
• Study Completion: 2020-12-29
• Results First Submitted: 2021-08-10
• Results First Submitted QC: 2021-08-10
• Results First Posted: 2021-09-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HBVAXPRO™	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™).

Primary Outcome Measures

Name	Time	Method
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™	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.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen	Day 1 and Day 30	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.

Trial Locations

Locations (10)

Porin rokotetutkimusklinikka ( Site 0008); 🇫🇮 Pori, Satakunta, Finland

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009); 🇫🇮 Kokkola, Mellersta Osterbotten, Finland

Seinajoki Vaccine Research Center ( Site 0010); 🇫🇮 Seinajoki, Pohjanmaa, Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004); 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001); 🇫🇮 Tampere, Pirkanmaa, Finland

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007); 🇫🇮 Espoo, Uusimaa, Finland

Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005); 🇫🇮 Helsinki, Uusimaa, Finland

Ita-Helsingin Rokotetutkimuskeskus ( Site 0006); 🇫🇮 Helsinki, Uusimaa, Finland

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003); 🇫🇮 Jarvenpaa, Uusimaa, Finland

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002); 🇫🇮 Turku, Varsinais-Suomi, Finland