Completed

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

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What is being tested

Hepatitis B vaccine

Drug
Who is being recruted

Blood-Borne Infections+8

+ Communicable Diseases

+ Digestive System Diseases

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Phase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Oxford
Last updated: January 14, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Oxford
Last updated: January 14, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesVirus DiseasesHepadnaviridae InfectionsHepatitis B

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, United KingdomOpen Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) in Google Maps
CompletedOne Study Center