Hepatitis B Clinical Trial
Official title:
Long-term Antibody Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Previously Vaccinated With Infanrix Hexa Vaccine
Verified date | August 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Status | Completed |
Enrollment | 300 |
Est. completion date | September 28, 2011 |
Est. primary completion date | September 28, 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 8 Years |
Eligibility |
Inclusion Criteria: - Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. - A male or female 7 to 8 years of age at the time of enrolment. - Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age. - Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment. - In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator. - Healthy subjects as established by medical history and clinical examination before entering into the study. 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. - 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 fourth dose of Infanrix hexa™ booster in the second year of life. - History of or intercurrent hepatitis B disease. - Hepatitis B vaccination at birth. - 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 hepatitis B vaccine challenge dose. - Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose 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. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Acute disease and/or fever at the time of enrolment. |
Country | Name | City | State |
---|---|---|---|
Germany | GSK Investigational Site | Bad Saulgau | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Berlin | |
Germany | GSK Investigational Site | Bindlach | Bayern |
Germany | GSK Investigational Site | Braunatal | Hessen |
Germany | GSK Investigational Site | Frankenthal | Rheinland-Pfalz |
Germany | GSK Investigational Site | Kehl | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Kempten | Bayern |
Germany | GSK Investigational Site | Muenster | Nordrhein-Westfalen |
Germany | GSK Investigational Site | Oberstenfeld | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Tuttlingen | Baden-Wuerttemberg |
Germany | GSK Investigational Site | Worms | Rheinland-Pfalz |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (=) 100 Milli-International Units Per Milliliter (mIU/mL) | A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | |
Secondary | Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine. | Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. |
Before (Day 0) a challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine | Anti-HBs antibody concentrations cut-off values assessed were = 6.2 mIU/mL (previously 3.3 mIU/mL), = 10 mIU/mL, = 10 mIU/mL to <100 mIU/mL and = 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | Before (Day 0) a challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values | Anti-HBs antibody concentrations cut-off values assessed were = 6.2 mIU/mL (previously 3.3 mIU/mL) and = 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | |
Secondary | Anti-HBs Antibody Concentrations | Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. | One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose | The anamnestic response is defined as an antibody concentration = 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point = 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off. | After Engerix-B Kinder challenge dose (Month 1) | |
Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) | Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was > 50 millimeter (mm). | During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature. Any temperature was defined as axillary temperature = 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature > 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. |
During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects Reporting Any Unsolicited AEs | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. | During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine | |
Secondary | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. | After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |