Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders

University of Aarhus

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Biological: Twinrix

Study type: Interventional

Funder types: Other

Identifiers

NCT01451801

SJF0001

Details and patient eligibility

About

Previous studies have shown that 5-10% of Hepatitis B Virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. These individuals are defined as non-responders. The investigators wish to investigate if mounting another kind of immune response, called the cellular immune (CMI) response, protects these non-responders.

Aim/Hypothesis

Primary aims:

1. To estimate the CMI response in serologic non-responders after receiving a standard course of HBV immunization

   Secondary aims:

2. To establish the prevalence of serological non-responders after a standard course of HBV vaccination.

3. To assess the safety of the vaccine.

4. Evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of HBV immunization

5. To compare the immunological profile before and after a standard HBV vaccination regimen on non-responders and responders

6. Establish a rapid test for measuring CMI after being HBV vaccinated.

A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months. Blood is drawn at 0 and 8 months from all participants. The blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed participant information and consent
• Age over 18 years
• Women of childbearing potential must use effective contraceptives

Exclusion criteria

• previous HBV infection
• previous HBV immunization
• pregnancy (or planned pregnancy within 6 months)
• allergy to contents in the vaccine (formaldehyde).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

HBsAg

Other group

Treatment:

Biological: Twinrix