- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Oxfordshire
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Oxford, Oxfordshire, Regno Unito, OX3 7LE
- Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
Lasso di tempo: 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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: 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
Lasso di tempo: 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).
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Dominic Kelly, Oxford Vaccine Group
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Epatite, virale, umana
- Infezioni da Hepadnaviridae
- Infezioni da virus del DNA
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite B
- Epatite
- Epatite A
Altri numeri di identificazione dello studio
- OVG 2012/09
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Epatite B
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Northwestern UniversityNational Cancer Institute (NCI)Attivo, non reclutanteLinfoma diffuso a grandi cellule B | Linfoma diffuso a grandi cellule B, non altrimenti specificato | Linfoma a cellule B di alto grado, non altrimenti specificato | Linfoma a grandi cellule B ricco di cellule T/istiociti | Linfoma a cellule B di alto grado con riarrangiamenti di MYC e BCL2... e altre condizioniStati Uniti
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Nathan DenlingerBristol-Myers SquibbReclutamentoLinfoma non Hodgkin a cellule B ricorrente | Linfoma diffuso a grandi cellule B-ricorrente | Linfoma follicolare ricorrente | Linfoma ricorrente a cellule B di alto grado | Linfoma primario mediastinico a grandi cellule B-ricorrente | Linfoma non Hodgkin indolente a cellule B trasformato in linfoma... e altre condizioniStati Uniti
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National Cancer Institute (NCI)Attivo, non reclutanteLinfoma diffuso ricorrente a grandi cellule B Tipo a cellule B attivato | Linfoma diffuso a grandi cellule B refrattario Tipo di cellule B attivatoStati Uniti, Arabia Saudita
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenAttivo, non reclutanteLinfoma diffuso ricorrente a grandi cellule B | Linfoma diffuso a grandi cellule B refrattario | CD20 Positivo | Linfoma diffuso a grandi cellule B stadio I | Linfoma diffuso a grandi cellule B stadio II | Linfoma diffuso a grandi cellule B stadio III | Linfoma diffuso a grandi cellule B stadio IVStati Uniti
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Curocell Inc.ReclutamentoLinfoma a cellule B di alto grado | Linfoma diffuso a grandi cellule B (DLBCL) | Linfoma primario a grandi cellule B del mediastino (PMBCL) | Linfoma follicolare trasformato (TFL) | Linfoma refrattario a grandi cellule B | Linfoma a grandi cellule B recidivatoCorea, Repubblica di
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Lapo AlinariReclutamentoLinfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma refrattario a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC e BCL2 o BCL6 | Linfoma refrattario a cellule... e altre condizioniStati Uniti
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Ohio State University Comprehensive Cancer CenterReclutamentoLinfoma diffuso a grandi cellule B | Linfoma a cellule B di alto grado | Linfoma diffuso a grandi cellule B, non altrimenti specificato | Linfoma diffuso a grandi cellule B Tipo di cellule B del centro germinaleStati Uniti
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First Affiliated Hospital Xi'an Jiaotong UniversityEureka Therapeutics Inc.SconosciutoLinfoma CD19+, cellule B | Leucemia CD19+, cellule BCina
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University of NebraskaBristol-Myers SquibbReclutamentoLinfoma follicolare | Linfoma non Hodgkin refrattario | Linfoma a cellule B di alto grado | DLBCL - Linfoma diffuso a grandi cellule B | Linfoma non Hodgkin recidivato | Linfoma mediastinico a grandi cellule B | Linfoma non Hodgkin a cellule B indolenteStati Uniti
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Northwestern UniversityNational Cancer Institute (NCI)ReclutamentoLinfoma mediastinico primario ricorrente (timico) a grandi cellule B | Linfoma a grandi cellule B del mediastino primario (timico) refrattario | Linfoma ricorrente a cellule B di alto grado con riarrangiamenti di MYC, BCL2 e BCL6 | Linfoma refrattario a cellule B di alto grado con riarrangiamenti... e altre condizioniStati Uniti
Prove cliniche su Hepatitis B vaccine
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TASK Applied ScienceCompletatoCOVID-19 | SARS-CoV-2Sud Africa
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National Institute of Allergy and Infectious Diseases...Dynavax Technologies CorporationAttivo, non reclutanteInfezione da HIV | Epatite BStati Uniti, Haiti, Botswana, Filippine, Tailandia, Brasile, Kenya, Malawi, Sud Africa, Uganda, Vietnam
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BioNTech SECompletatoCOVID-19 | Infezione da SARS-CoV2 | Malattia respiratoria acuta SARS-CoV-2 | SARS (malattia)Stati Uniti, Germania, Tacchino, Sud Africa
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ChemoCentryxMedpace, Inc.CompletatoGlomerulosclerosi focale segmentale | FSGS | GlomerulosclerosiStati Uniti, Francia, Italia, Australia, Regno Unito, Canada, Nuova Zelanda, Polonia
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Indiana UniversityAlcon ResearchCompletato
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Marya Strand, MDCompletatoSindrome da stress respiratorioStati Uniti
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Wright State UniversityReclutamentoCancro della pelleStati Uniti
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Eli Lilly and CompanyCompletato
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Epstein, Arthur B., OD, FAAOAlcon ResearchCompletato
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Coopervision, Inc.COREAttivo, non reclutante