New Methods to Measure the Immune Response to Hepatitis B Vaccine

NCT ID: NCT01821547

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Hepatitis B vaccine

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

Intervention Type: DRUG

Other Intervention Names

HBvaxPRO, 10μg/ml, Sanofi Pastuer

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominic Kelly

Role: PRINCIPAL_INVESTIGATOR

Oxford Vaccine Group

Locations

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

OVG 2012/09

Identifier Type: -

Identifier Source: org_study_id