Clinical trial NCT01138098: Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children
Official title: Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in 11-12 Year Old Children, Previously Vaccinated With DTPa-HBV-IPV/Hib Vaccine in Study 217744/031
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Persistence
challenge dose
Engerix-B
immune response
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 185
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.

Detailed description: Subjects who participated in the primary study 217744/031 (NCT01457495) will be invited at the age of 11-12 years to participate in this follow-up study.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
* Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
* Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
* Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Child in care.
* Use of any investigational or non-registered product drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
* Receipt of hepatitis B (containing) vaccine after vaccination in the primary study 217744/031 (NCT01457495).
* History of hepatitis B disease.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)
timeFrame: One month after a challenge dose of Engerix-B vaccine
Secondary outcomes:
measure: Number of Subjects With an Anamnestic Response to a Challenge Dose
timeFrame: Before and one month after a challenge dose of Engerix-B vaccine
measure: Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL
timeFrame: Before and one month after a challenge dose of Engerix-B vaccine
measure: Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL
timeFrame: Before and one month after a challenge dose of Engerix-B vaccine
measure: Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL
timeFrame: Before the challenge dose of Engerix-B vaccine
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) follow-up period after a challenge dose of Engerix-B vaccine
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: After the challenge dose of Engerix-B vaccine up to the study end
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Dolny Kubin
country: Slovakia
facility: GSK Investigational Site
city: Dubnica Nad Vahom
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Nova Dubnica
country: Slovakia
facility: GSK Investigational Site
city: Nove Zamky
country: Slovakia
facility: GSK Investigational Site
city: Puchov
country: Slovakia
facility: GSK Investigational Site
city: Roznava
country: Slovakia
facility: GSK Investigational Site
city: Trebisov
country: Slovakia
facility: GSK Investigational Site
city: Zlate Moravce
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Avdicova M, Crasta PD, Hardt K, Kovac M. Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age. Vaccine. 2015 May 28;33(23):2727-33. doi: 10.1016/j.vaccine.2014.06.070. Epub 2014 Jun 22.