Effects of paracetamol use on the immune response after hepatitis B vaccinatio

Conditions: o medical conditions will be studied. The association between timing of the use of paracetamol during hepatitis B vaccination and the development of an antibody response will be studied in students that are vaccinated with the hepatitis B vaccin as part of their healthcare training.
MedDRA version: 13.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1Level: LLTClassification code 10033765Term: Paracetamol normalSystem Organ Class: 10022891 - Investigations
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-000923-33-NL

Lead Sponsor: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 0

Inclusion Criteria

- Student of the Hogeschool Utrecht qualified for a hepatitis B vaccination
- Good health
- Able to perform the study according to the procedures
- Informed consent present
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of acute or chronic hepatitis B
- Earlier hepatitis B vaccination
- Evidence of a serious disease, that needs immunosuppresive treatment
- A known primary or secondary immunodeficiency

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is divided in two parts.<br>Part 1: Demonstrate that there is an immune modulating effect on the antibody response by profylactic use of paracetamol during hepatitis B vaccination in adults.<br>Part 2. Study the association between timing of the use of paracetamol during hepatitis B vaccination and the development of the antibody response in adults. ;Secondary Objective: The secondary objective is the same in both parts of the study. To find out which mechanisms are responsible for the decreased antibody response by analyzinig the functionality of lymphocyte subpopulations.;Primary end point(s): Hepatitis B antibody concentrations;Timepoint(s) of evaluation of this end point: Immediate before the third vaccination <br>One month after the third vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in the functionality of the specific lymphocyte subpopulations in the blood;Timepoint(s) of evaluation of this end point: Immediate before the third vaccination <br>One month after the third vaccination