Clinical trial NCT01847430: Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder
Official title: Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Healthy
Hepatitis B
Adolescents
Engerix™-B Kinder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 303
Sex: ALL
Minimum age (years): 15
Maximum age (years): 16
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 assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.

Detailed description: This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013.

The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen) antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA).

Additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.

Eligibility criteria: Inclusion Criteria:

* Subject's parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
* A male or female between, and including, 15 and 16 years of age at the time of the vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Documented evidence of previous vaccination with three consecutive doses of Engerix™-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
* Female subjects of non-childbearing potential may be enrolled in the study.

  * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* 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.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Previous hepatitis B vaccination since administration of the third dose of Engerix™-B Kinder.
* History of hepatitis B disease.
* Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period.
* 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 vaccine/product.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.
timeFrame: One month after the challenge dose (Month 1)
Secondary outcomes:
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.
timeFrame: Before (Day 0) and one month after the challenge dose (Month 1)
measure: Antibody Titers Against Hepatitis B Virus
timeFrame: Before (Day 0) and one month (Month 1) after the challenge dose
measure: Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.
timeFrame: Prior to vaccination with the challenge dose
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after the challenge dose
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 4-day (Days 0-3) follow-up period after the challenge dose
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs).
timeFrame: During the 31-day (Days 0-30) follow-up period after the challenge dose
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Day 0 to Month 1)
Other outcomes:
Locations:
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kirchheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Goch
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Neumuenster
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Van Der Meeren O, Behre U, Crasta P. Immunity to hepatitis B persists in adolescents 15-16 years of age vaccinated in infancy with three doses of hepatitis B vaccine. Vaccine. 2016 May 23;34(24):2745-9. doi: 10.1016/j.vaccine.2016.04.013. Epub 2016 Apr 16.