Clinical trial NCT00984139: Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
Official title: Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: persistence
HBV
Long-term
Engerix™-B Kinder
Hepatitis B
adolescent
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 306
Sex: ALL
Minimum age (years): 12
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female of 12 to 13 years of age at the time of enrolment.
* With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
* Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
* 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.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

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.
* Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix-B vaccine.
* History of hepatitis B disease.
* Hepatitis B vaccination at birth.
* Adolescents living in institutional care.
* Planned administration /administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
* Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge..
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
* 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.

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
timeFrame: One month after the challenge dose (Month 1)
measure: Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.
timeFrame: One month after the challenge dose (Month 1)
Secondary outcomes:
measure: Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
timeFrame: Before (Day 0) and one month (Month 1) after the challenge dose
measure: Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
timeFrame: Before (Day 0) and one month (Month 1) after the challenge dose
measure: Number of Subjects With Solicited Local and General Symptoms
timeFrame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
measure: Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.
timeFrame: One month after the challenge dose (Month 1)
measure: Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.
timeFrame: One month after the challenge dose (Month 1)
Other outcomes:
Locations:
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Pforzheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
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: Cham
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Gilching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kempten
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kirchheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Braunatal
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Duisburg
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Weimar
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17.