- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01821547
New Methods to Measure the Immune Response to Hepatitis B Vaccine
Hepatitis B Immunisation: A Two-part Study Investigating Antigen Specific B Cell Receptors
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Oxfordshire
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Oxford, Oxfordshire, Royaume-Uni, OX3 7LE
- Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
All participants for both parts 1 and 2 must meet the following conditions in order to be enrolled:
- Participant is willing and able to give informed consent for participation in the study
- Healthy Male or Female, aged 18 - 60 years
- No allergies to the vaccine or its excipients
Participants enrolling in Part 1 must also meet the following conditions:
- Participant has previously received a primary immunisation course of HepB vaccine (3 primary doses). The 4th booster dose recommended after 12 months is not a requirement. There are a variety of possible recommended schedules, and any may have been used as long as the final vaccine (or booster vaccine) was given at least 12 months prior to the participant enrolling in the study.
- Participant is willing to allow their General Practitioner to be notified, if appropriate, of participation in the study
Participants enrolling in Part 2 must also meet the following conditions Participant receiving HBvaxPro® (the usual vaccine given within the Occupational Health Department).
Exclusion Criteria:
The participant may not enter either study if ANY of the following apply:
Have any known or suspected impairment or alteration of immune function, resulting from, for example:
- Congenital or acquired immunodeficiency (including IgA deficiency)
- Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- Autoimmune disease
- Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy.
- Chronic illness that could interfere with immunological function or donation of the required volumes of blood (e.g. cardiac or renal disease, diabetes, or auto-immune disorders).
- Receipt of a HepB booster vaccine within the past 12 months.
- Prior history of anaphylactic reaction to a previous dose of a Hepatitis B containing vaccine or known hypersensitivity to any vaccine component;
- Receipt of blood, blood products, or plasma derivatives within the past 3 months.
- Total blood donation greater than 50 ml within the past 3 months.
- Thrombocytopenia or any bleeding disorder.
- Pregnancy as confirmed by a positive pregnancy test, or currently breastfeeding.
- Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination.
- Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination.
- Enrolled in another study, which, in the opinion of the investigator, could compromise the integrity of either study being conducted.
- A member of staff on the delegation log
- According to the TOPS database, have recently taken part in a significant number of other studies, which, in the opinion of the investigator, warrant exclusion from further studies.
- Participant is a known non-responder to the HepB vaccine
- Have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Unable to understand English, or what will be required from them during the study.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Part 2- To assess B cell VH/L gene segment usage by HepB specific B cells during and following administration of a three dose course of HepB vaccine given at 0,1, 2 or 0, 1, 6 months.
Délai: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation
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HepB specific cells will be isolated using magnetic-activated cell sorting, and fluorescence-activated cell sorting.
VH/L gene segments will be amplified by PCR, and DNA prepared for sequencing.
Bioinformatic approaches will then be used to create frequency tables of the different V, D and J exons that comprise these gene segments.
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0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation
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Part 1- To validate B cell assays and assess the kinetics of HepB specific B cell subsets following administration of a booster dose of HepB vaccine given to previously immunised healthy adults.
Délai: 0, 7, 14, 21 and 28 days after immunisation
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HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
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0, 7, 14, 21 and 28 days after immunisation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Part 1 • To measure HepB surface antigen-specific antibody concentration following administration of a booster dose of HepB vaccine given to previously immunised healthy adults
Délai: 0 and 28 days after immunisation
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Antibody concentrations will be determined from blood plasma using an ELISA
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0 and 28 days after immunisation
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Part 1 • To assess B-cell receptor VH/L gene sequences used in HepB specific and non-antigen specific B-cells prior to and following administration of a booster dose of HepB vaccine given to previously immunised healthy adults
Délai: 0, 7, 14, 21 and 28 days after immunisation
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VH/L gene segments will be amplified by PCR, and DNA prepared for sequencing.
Bioinformatic approaches will then be used to create frequency tables of the different V, D and J exons that comprise these gene segments.
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0, 7, 14, 21 and 28 days after immunisation
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Part 1 • Comparison of B cell receptor VH/L gene segment usage as determined by two different next-generation sequencing methods (RNA-sequencing and 454).
Délai: 0, 7, 14, 21 and 28 days after immunisation, as required
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Different sequencing protocols introduce different types of error and bias into the resulting sequence datasets.
VH/L gene segments will sequenced using two different techniques.
Bioinformatic approaches and descriptive analysis will then be used to compare the effects of the two different protocols.
Frequency tables of the different V, D and J exons that comprise these gene segments will be generated, for comparison.
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0, 7, 14, 21 and 28 days after immunisation, as required
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Part 1 • Collection of mRNA for subsequent gene expression analysis
Délai: 0, 7, 14, 21 and 28 days after immunisation
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0, 7, 14, 21 and 28 days after immunisation
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Part 2 • To measure HepB specific plasma and memory B cell frequencies during and following administration of a three dose course of HepB vaccine given at 0, 1, 2 or 0, 1, 6 months.
Délai: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation
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HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
|
0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation
|
Part 2 • To measure HepB surface antigen-specific antibody concentration during and following administration of a three dose course of HepB vaccine given at 0,1, 2 or 0, 1, 6 months.
Délai: 0 days after the second immunisation, and 0 and 40 days after the third immunisation
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Antibody concentrations will be determined from blood plasma using an ELISA
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0 days after the second immunisation, and 0 and 40 days after the third immunisation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dominic Kelly, Oxford Vaccine Group
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Hépatite, virale, humaine
- Infections à Hépadnaviridae
- Infections par le virus de l'ADN
- Infections à entérovirus
- Infections à Picornaviridae
- Hépatite B
- Hépatite
- Hépatite A
Autres numéros d'identification d'étude
- OVG 2012/09
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Hépatite B
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National Cancer Institute (NCI)Actif, ne recrute pasLymphome B diffus récurrent à grandes cellules de type B activé | Lymphome diffus à grandes cellules B réfractaire de type B activéÉtats-Unis, Arabie Saoudite
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Nathan DenlingerBristol-Myers SquibbRecrutementLymphome non hodgkinien récurrent à cellules B | Lymphome diffus à grandes cellules B récurrent | Lymphome folliculaire récurrent | Lymphome récurrent à cellules B de haut grade | Lymphome médiastinal primitif à grandes cellules B récurrent | Lymphome non hodgkinien indolent à cellules B... et d'autres conditionsÉtats-Unis
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Northwestern UniversityNational Cancer Institute (NCI)Actif, ne recrute pasLymphome diffus à grandes cellules B | Lymphome diffus à grandes cellules B, non spécifié ailleurs | Lymphome à cellules B de haut grade, non spécifié ailleurs | Lymphome à grandes cellules B riche en cellules T/histiocytes | Lymphome à cellules B de haut grade avec réarrangements MYC... et d'autres conditionsÉtats-Unis
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Molecular Templates, Inc.RésiliéLymphome diffus à grandes cellules B réfractaire | Lymphome diffus à grandes cellules B récidivant | Lymphome non hodgkinien, cellule BÉtats-Unis
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First Affiliated Hospital Xi'an Jiaotong UniversityEureka Therapeutics Inc.InconnueCellules T ET190L1-ARTEMIS™ dans la leucémie et le lymphome à cellules B récidivants et réfractairesLymphome CD19+ à cellules B | Leucémie CD19+ à cellules BChine
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Northwestern UniversityNational Cancer Institute (NCI)RecrutementLymphome à grandes cellules B médiastinal primaire (thymique) récurrent | Lymphome à grandes cellules B réfractaire médiastinal primaire (thymique) | Lymphome B récurrent de haut grade avec réarrangements MYC, BCL2 et BCL6 | Lymphome réfractaire à cellules B de haut grade avec réarrangements... et d'autres conditionsÉtats-Unis
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Curocell Inc.RecrutementLymphome à cellules B de haut grade | Lymphome diffus à grandes cellules B (DLBCL) | Lymphome médiastinal primitif à grandes cellules B (PMBCL) | Lymphome folliculaire transformé (TFL) | Lymphome réfractaire à grandes cellules B | Lymphome à grandes cellules B récidivantCorée, République de
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Nanfang Hospital of Southern Medical UniversityRecrutementLymphome B | Leucémie aiguë lymphoblastique à cellules B | Leucémie à cellules B | Lymphome à cellules B réfractaire | Lymphome B récurrentChine
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Patrick C. Johnson, MDAstraZenecaRecrutementLymphome non hodgkinien réfractaire à cellules B | Lymphome diffus à grandes cellules B (DLBCL) | Lymphome folliculaire de grade 3b | Lymphomes B agressifs réfractaires | LNH agressif à cellules B | Lymphome de novo ou lymphome B indolent transformé | DLBCL, Nos sous-types génétiques | Lymphome... et d'autres conditionsÉtats-Unis
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Lapo AlinariRecrutementLymphome B récurrent de haut grade avec réarrangements MYC, BCL2 et BCL6 | Lymphome réfractaire à cellules B de haut grade avec réarrangements MYC, BCL2 et BCL6 | Lymphome B récurrent de haut grade avec réarrangements MYC et BCL2 ou BCL6 | Lymphome réfractaire à cellules B de haut grade... et d'autres conditionsÉtats-Unis
Essais cliniques sur Hepatitis B vaccine
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BioNTech SEComplétéCOVID-19 [feminine] | Infection par le SRAS-CoV2 | Maladie respiratoire aiguë SARS-CoV-2 | SRAS (maladie)États-Unis, Allemagne, Turquie, Afrique du Sud
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National Institute of Allergy and Infectious Diseases...Dynavax Technologies CorporationActif, ne recrute pasInfection par le VIH | Hépatite BÉtats-Unis, Haïti, Bostwana, Philippines, Thaïlande, Brésil, Kenya, Malawi, Afrique du Sud, Ouganda, Viêt Nam
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Marya Strand, MDComplétéSyndrome de détresse respiratoireÉtats-Unis
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ChemoCentryxMedpace, Inc.ComplétéGlomérulosclérose segmentaire focale | FSGS | GloméruloscléroseÉtats-Unis, France, Italie, Australie, Royaume-Uni, Canada, Nouvelle-Zélande, Pologne
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Indiana UniversityAlcon ResearchComplétéMyopie | HypermétropieÉtats-Unis
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Eli Lilly and CompanyComplété
-
Epstein, Arthur B., OD, FAAOAlcon ResearchComplété
-
Wright State UniversityRecrutementCancer de la peauÉtats-Unis
-
Coopervision, Inc.Actif, ne recrute pas
-
Coopervision, Inc.COREActif, ne recrute pas