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Hepatitis BPhase 4NCT01821547

New Methods to Measure the Immune Response to Hepatitis B Vaccine

A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B
What is being tested?
Hepatitis B vaccine
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2013to May 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

    Oxford, Oxfordshire, OX3 7LE

Other trials in United Kingdom

About this study

Official title: Hepatitis B Immunisation: A Two-part Study Investigating Antigen Specific B Cell Receptors

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.

Conditions
Hepatitis B
Being tested
Hepatitis B vaccine
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatitis B vaccineDrug

    Also called HBvaxPRO, 10μg/ml, Sanofi Pastuer

    Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation

  2. 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.

    Measured: 0, 7, 14, 21 and 28 days after immunisation

Secondary outcomes (6)

  1. 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

    Measured: 0 and 28 days after immunisation

  2. 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.

    Measured: 0, 7, 14, 21 and 28 days after immunisation

  3. 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.

    Measured: 0, 7, 14, 21 and 28 days after immunisation, as required

  4. Part 1 • Collection of mRNA for subsequent gene expression analysis

    Measured: 0, 7, 14, 21 and 28 days after immunisation

  5. 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.

    Measured: 0 and 7 days after the second immunisation, and 0, 7 and 40 days after the third immunisation

  6. 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

    Measured: 0 days after the second immunisation, and 0 and 40 days after the third immunisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2014
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01821547
Sponsor's protocol ID
OVG 2012/09
Status last verified
Jun 2016
First submitted
18 Mar 2013
Last updated
14 Jan 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hepatitis B vaccine in people with Hepatitis B, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01821547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.

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