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New Methods to Measure the Immune Response to Hepatitis B Vaccine

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ClinicalTrials.gov Identifier: NCT01821547
Recruitment Status : Completed
First Posted : April 1, 2013
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE March 18, 2013
First Posted Date  ICMJE April 1, 2013
Last Update Posted Date January 14, 2021
Study Start Date  ICMJE March 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
  • 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. [ Time Frame: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation ]
    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.
  • 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. [ Time Frame: 0, 7, 14, 21 and 28 days after immunisation ]
    HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
  • 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 [ Time Frame: 0 and 28 days after immunisation ]
    Antibody concentrations will be determined from blood plasma using an ELISA
  • 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 [ Time Frame: 0, 7, 14, 21 and 28 days after immunisation ]
    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.
  • 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). [ Time Frame: 0, 7, 14, 21 and 28 days after immunisation, as required ]
    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.
  • 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. [ Time Frame: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation ]
    HepB specific B cell subsets will be identified using both ELISPOT and flow cytometry.
  • 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. [ Time Frame: 0 days after the second immunisation, and 0 and 40 days after the third immunisation ]
    Antibody concentrations will be determined from blood plasma using an ELISA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Methods to Measure the Immune Response to Hepatitis B Vaccine
Official Title  ICMJE Hepatitis B Immunisation: A Two-part Study Investigating Antigen Specific B Cell Receptors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hepatitis B
Intervention  ICMJE Drug: Hepatitis B vaccine
Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).
Other Name: HBvaxPRO, 10μg/ml, Sanofi Pastuer
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2013)
16
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821547
Other Study ID Numbers  ICMJE OVG 2012/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominic Kelly Oxford Vaccine Group
PRS Account University of Oxford
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP