Clinical trial NCT04490499: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-07-29
Enrollment: 207
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
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™
timeFrame: Day 30
Secondary outcomes:
measure: Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
timeFrame: Day 1 and Day 30
Other outcomes:
Locations:
city: Kokkola
country: Finland
facility: Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
state: Mellersta Osterbotten
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
state: Pirkanmaa
city: Seinajoki
country: Finland
facility: Seinajoki Vaccine Research Center ( Site 0010)
state: Pohjanmaa
city: Oulu
country: Finland
facility: Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
state: Pohjois-Pohjanmaa
city: Pori
country: Finland
facility: Porin rokotetutkimusklinikka ( Site 0008)
state: Satakunta
city: Espoo
country: Finland
facility: Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
state: Uusimaa
city: Helsinki
country: Finland
facility: Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
state: Uusimaa
city: Helsinki
country: Finland
facility: Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
state: Uusimaa
city: Jarvenpaa
country: Finland
facility: Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
state: Uusimaa
city: Turku
country: Finland
facility: Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
state: Varsinais-Suomi
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.