Paracetamol & Hepatitis B Vaccination Study

Completed

Conditions: Antibody response after paracetamol use during vaccination
Not Applicable

Registration Number: ISRCTN03576945

Lead Sponsor: ational Institute for Public Health and the Environment (RIVM) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 597

Inclusion Criteria

1. Healthy young health care students from the Hogeschool of Utrecht, who are routinely vaccinated against hepatitis B
2. 18 years or older, both male and female
3. Written informed consent

Exclusion Criteria

1. NSAIDs or paracetamol use within 48 hours before vaccination
2. History of acute or chronic hepatitis B
3. Earlier vaccination against hepatitis B
4. Medical immunosuppressive treatment
5. Primary or secondary immunodeficiency
6. Allergic reaction to components of the hepatitis B vaccination or paracetamol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the anti-HBs levels. Blood samples were collected prior (5-6 months after first vaccination) to and one month (6-7 months after first vaccination) after the second booster vaccination in blood collection tubes. Qualitative and quantitative HBsAg antibody levels in the sera were measured on the ADVIA Centaur XP system by using the ADVIA Centaur Anti-HBs assay according to the manufacturer's protocol.

Secondary Outcome Measures

Name	Time	Method
Alterations in the functionality of specific lymphocyte subpopulations in blood of participants that used paracetamol prophylactically or therapeutically. Blood was collected one month (7 months after first vaccination) after the second booster vaccination by using vacutainer cell preparation tubes containing sodium citrate. Peripheral blood mononuclear cells (PBMCs) were isolated from the tubes according to the procedures recommended by the manufacturer. Therafter, B-cells were purified by using the Easysep CD19 kit. Purified B-cells were characterized by FACS-analysis and after polyclonal stimulation memory B-cells specific for HBsAg were detected by ELISPOT. T-cells (PBMCs minus B cell fraction) were stimulated with HBsAg and tested for IFN-gamma secretion by ELISPOT.