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

NCT04490499 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V419-0132020-000126-26
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 10

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.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen

  Day 1 and Day 30

Study Arms (1)

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™).

Biological: HBVAXPRO™

Interventions

HBVAXPRO™ BIOLOGICAL

Single 0.5 mL intramuscular dose

Also known as: Hepatitis B virus (HBV) vaccine; V232

HBVAXPRO™

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (10)

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

Oulu, North Ostrobothnia, 90220, Finland

Location

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

Tampere, Pirkanmaa, 33100, Finland

Location

Seinajoki Vaccine Research Center ( Site 0010)

Seinajoki, Pohjanmaa, 60100, Finland

Location

Porin rokotetutkimusklinikka ( Site 0008)

Pori, Satakunta, 28100, Finland

Location

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Turku, Southwest Finland, 20520, Finland

Location

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

Espoo, Uusimaa, 02230, Finland

Location

Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)

Helsinki, Uusimaa, 00100, Finland

Location

Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)

Helsinki, Uusimaa, 00930, Finland

Location

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

Jarvenpaa, Uusimaa, 04400, Finland

Location

Related 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 Nov 30;18(5):2073747. doi: 10.1080/21645515.2022.2073747. Epub 2022 Jun 2.

  PMID: 35653552 RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines; Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 29, 2020
• Study Start: September 2, 2020
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: July 27, 2022
• Results First Posted: September 5, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

FI (10)