A Phase 4 interventional study of Hepatitis B vaccine in Hepatitis B, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.
Sponsored by University of Oxford · Phase 4, Interventional, and Basic science
Hepatitis B vaccine is a safe and effective vaccine used widely throughout the world. Because of this it is a useful vaccine in which to develop new methods for studying immune responses. Measuring the immune response to vaccines helps us to understand how they work and whether they are likely to protect any individual against infection. For most vaccines we measure the immune system's production of antibody after a vaccine has been given. The investigators want to develop new methods that give a far more detailed picture of the antibody response to vaccines than has previously been possible. These methods will investigate the genetic instructions used by each antibody producing cell to make antibody. These methods have the potential to give new insights into the way vaccines work, which could be applied to studying vaccines and vaccine schedules in the future.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All participants for both parts 1 and 2 must meet the following conditions in order to be enrolled:
Participants enrolling in Part 1 must also meet the following conditions:
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:
Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).
Also known as: HBvaxPRO, 10μg/ml, Sanofi Pastuer
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.
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.
Time frame: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation
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.
HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
Time frame: 0, 7, 14, 21 and 28 days after immunisation
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
Antibody concentrations will be determined from blood plasma using an ELISA
Time frame: 0 and 28 days after immunisation
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
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.
Time frame: 0, 7, 14, 21 and 28 days after immunisation
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).
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.
Time frame: 0, 7, 14, 21 and 28 days after immunisation, as required
Part 1 • Collection of mRNA for subsequent gene expression analysis
Time frame: 0, 7, 14, 21 and 28 days after immunisation
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.
HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
Time frame: 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.
Antibody concentrations will be determined from blood plasma using an ELISA
Time frame: 0 days after the second immunisation, and 0 and 40 days after the third immunisation
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Oxford