Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
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)
1 other identifier
interventional
306
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2009
Shorter than P25 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedStudy Start
First participant enrolled
October 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2010
CompletedResults Posted
Study results publicly available
March 1, 2011
CompletedAugust 20, 2018
September 1, 2016
6 months
September 24, 2009
February 3, 2011
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
One month after the challenge dose (Month 1)
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.
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
One month after the challenge dose (Month 1)
Secondary Outcomes (7)
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Solicited Local and General Symptoms
During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination
Number of Subjects With Serious Adverse Events (SAEs)
After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
- +2 more secondary outcomes
Study Arms (1)
Engerix-B Group
EXPERIMENTALSubjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
Interventions
Intramuscular, one dose.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (24)
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163, Germany
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, 75172, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Gilching, Bavaria, 82205, Germany
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435, Germany
GSK Investigational Site
Kirchheim, Bavaria, 85551, Germany
GSK Investigational Site
Munich, Bavaria, 81375, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Braunatal, Hesse, 34225, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47137, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Weimar, Thuringia, 99425, Germany
GSK Investigational Site
Berlin, 10315, Germany
GSK Investigational Site
Berlin, 10967, Germany
GSK Investigational Site
Berlin, 13055, Germany
Related Publications (1)
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.
PMID: 22508412DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following complete retesting and reanalysis.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 25, 2009
Study Start
October 12, 2009
Primary Completion
April 7, 2010
Study Completion
April 7, 2010
Last Updated
August 20, 2018
Results First Posted
March 1, 2011
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.