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

Completed

• Conditions: vaccinatierespons; er wordt geen aandoening bestudeerd; nvt

• Registration Number: NL-OMON38027
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 489

Inclusion Criteria

- good health
- able to perform the study according to the procedures
- informed consent present

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase 1: Antibody concentrations prior to and 1 month after the third<br /><br>vaccination (booster vaccination) will be measured. Antibody<br /><br>concentrations expected to be 65% lower in participants that used paracetamol<br /><br>prophylactically. This expectation is based on findings in baby's (Prymula et<br /><br>al., 2009).<br /><br><br /><br>Phase 2: Antibody concentrations prior to and 1 month after the third<br /><br>vaccination (booster vaccination) will be measured.<br /><br>It is expected that the titers in the groups treated therapeutically with<br /><br>paracetamol will be inbetween the control and prophylactically treated group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Alterations in the functionality of specific lymfocyte subpopulations in blood<br /><br>(1 month after the third vaccination) of participants that used paracetamol<br /><br>prophylactically.</p><br>