Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
NCT ID: NCT00805389
Last Updated: 2018-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
713 participants
INTERVENTIONAL
2008-12-15
2011-07-14
Brief Summary
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This Protocol Posting has been updated following Protocol amendment 6, October 2009. The section impacted is Eligibility Criteria
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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GSK223192A 1 Group
Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
GSK Biologicals' Hepatitis B vaccines (GSK223192A)
2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
HBsAg (Booster injection)
Single dose intramuscular injection
GSK223192A 2 Group
Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
GSK Biologicals' Hepatitis B vaccines (GSK223192A)
2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
HBsAg (Booster injection)
Single dose intramuscular injection
GSK223192A 3 Group
Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
GSK Biologicals' Hepatitis B vaccines (GSK223192A)
2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
HBsAg (Booster injection)
Single dose intramuscular injection
Fendrix Group
Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Fendrix™
2 doses intramuscular injections
HBsAg (Booster injection)
Single dose intramuscular injection
Engerix-B Group
Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group - subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) - additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
Engerix-B™
2 doses intramuscular injections
HBsAg (Booster injection)
Single dose intramuscular injection
Interventions
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Engerix-B™
2 doses intramuscular injections
Fendrix™
2 doses intramuscular injections
GSK Biologicals' Hepatitis B vaccines (GSK223192A)
2 doses intramuscular injections 3 different formulations of (GSK223192A), each administered to 1 group
HBsAg (Booster injection)
Single dose intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female between, and including, 18 and 45 years at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria
* Previous vaccination against Hepatitis B.
* Positive for anti-HBs antibodies, antiHBc antibodies, HBsAg, HCV antibodies and/or HIV.
* Any previous administration of specific adjuvant components.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the influenza vaccine (pandemic or seasonal) which can be administered \> 21 days preceding or \> 21 days following each primary vaccine dose (Doses 1 and 2) AND \> 7 days preceding or \> 7 days following the booster dose.
* Administration of immunoglobulins and/or any blood products within the last 3 months.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Current serious neurologic or mental disease.
* Any past or current malignancies and lymphoproliferative disorders.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, autoimmune disease or anemia, as determined by physical examination or laboratory screening tests at the discretion of the investigator.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Other conditions that the principal investigator judges may interfere with study findings.
18 Years
45 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
La Louvière, , Belgium
GSK Investigational Site
Wilrijk, , Belgium
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Haag, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Regensburg, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
Countries
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References
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Tasdighian S, Bechtold V, Essaghir A, Saeys Y, Burny W. An innate immune signature induced by AS01- or AS03-adjuvanted vaccines predicts the antibody response magnitude and quality consistently over time. Front Immunol. 2024 Aug 14;15:1412732. doi: 10.3389/fimmu.2024.1412732. eCollection 2024.
Moris P, Bellanger A, Ofori-Anyinam O, Jongert E, Yarzabal Rodriguez JP, Janssens M. Whole blood can be used as an alternative to isolated peripheral blood mononuclear cells to measure in vitro specific T-cell responses in human samples. J Immunol Methods. 2021 May;492:112940. doi: 10.1016/j.jim.2020.112940. Epub 2021 Jan 23.
De Mot L, Bechtold V, Bol V, Callegaro A, Coccia M, Essaghir A, Hasdemir D, Ulloa-Montoya F, Siena E, Smilde A, van den Berg RA, Didierlaurent AM, Burny W, van der Most RG. Transcriptional profiles of adjuvanted hepatitis B vaccines display variable interindividual homogeneity but a shared core signature. Sci Transl Med. 2020 Nov 11;12(569):eaay8618. doi: 10.1126/scitranslmed.aay8618.
Hasdemir D, van den Berg RA, van Kampen A, Smilde AK. Modeling adaptive response profiles in a vaccine clinical trial. BMC Med Res Methodol. 2020 Jul 16;20(1):191. doi: 10.1186/s12874-020-01070-3.
Burny W, Marchant A, Herve C, Callegaro A, Caubet M, Fissette L, Gheyle L, Legrand C, Ndour C, Tavares Da Silva F, van der Most R, Willems F, Didierlaurent AM, Yarzabal J; ECR-008 study group. Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans. Vaccine. 2019 Mar 28;37(14):2004-2015. doi: 10.1016/j.vaccine.2019.02.015. Epub 2019 Mar 5.
Burny W, Callegaro A, Bechtold V, Clement F, Delhaye S, Fissette L, Janssens M, Leroux-Roels G, Marchant A, van den Berg RA, Garcon N, van der Most R, Didierlaurent AM; ECR-002 Study Group. Different Adjuvants Induce Common Innate Pathways That Are Associated with Enhanced Adaptive Responses against a Model Antigen in Humans. Front Immunol. 2017 Aug 14;8:943. doi: 10.3389/fimmu.2017.00943. eCollection 2017.
Related Links
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IPD for this study will be made available via the Clinical Study Data Request site.
Other Identifiers
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112115
Identifier Type: -
Identifier Source: org_study_id
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