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

Effects of paracetamol use on the immune response after hepatitis B vaccination - Paracetamol and hepatitis B vaccination

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38027
Enrollment
489
Registered
2011-04-28
Start date
2011-08-06
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vaccinatierespons er wordt geen aandoening bestudeerd nvt

Interventions

Phase 1: There is one intervention and one control group. The intervention group have to take paracertamol for 24 hours (1000 mg / 8h) starting directly after the vaccination. The control group take

Sponsors

RIVM
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Alterations in the functionality of specific lymfocyte subpopulations in blood (1 month after the third vaccination) of participants that used paracetamol prophylactically.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)