title: Effects of prophylactic and therapeutic paracetamol treatment during vaccination on hepatitis B antibody levels in adults: two open-label, randomized controlled trials.
abstract: Worldwide, paracetamol is administered as a remedy for complaints that occur after vaccination. Recently published results indicate that paracetamol inhibits the vaccination response in infants when given prior to vaccination. The goal of this study was to establish whether paracetamol exerts similar effects in young adults. In addition, the effect of timing of paracetamol intake was investigated. In two randomized, controlled, open-label studies 496 healthy young adults were randomly assigned to three groups. The study groups received paracetamol for 24 hours starting at the time of (prophylactic use) - or 6 hours after (therapeutic use) the primary (0 month) and first booster (1 month) hepatitis B vaccination. The control group received no paracetamol. None of the participants used paracetamol around the second booster (6 months) vaccination. Anti-HBs levels were measured prior to and one month after the second booster vaccination on ADVIA Centaur XP. One month after the second booster vaccination, the anti-HBs level in the prophylactic paracetamol group was significantly lower (p = 0.048) than the level in the control group (4257 mIU/mL vs. 5768 mIU/mL). The anti-HBs level in the therapeutic paracetamol group (4958 mIU/mL) was not different (p = 0.34) from the level in the control group. Only prophylactic paracetamol treatment, and not therapeutic treatment, during vaccination has a negative influence on the antibody concentration after hepatitis B vaccination in adults. These findings prompt to consider therapeutic instead of prophylactic treatment to ensure maximal vaccination efficacy and retain the possibility to treat pain and fever after vaccination.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN03576945.
authors.affiliation: Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands; Department of Toxicogenomics, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Anne M C M
authors.initials: AM
authors.lastname: Doedée
authors.affiliation: Medical Microbiology and Virology, University Medical Centre Utrecht, Utrecht, The Netherlands.
authors.forename: Greet J
authors.initials: GJ
authors.lastname: Boland
authors.affiliation: Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Jeroen L A
authors.initials: JL
authors.lastname: Pennings
authors.affiliation: Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Arja
authors.initials: A
authors.lastname: de Klerk
authors.affiliation: Centre for Immunology of Infectious Diseases and Vaccines, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Guy A M
authors.initials: GA
authors.lastname: Berbers
authors.affiliation: Centre for Immunology of Infectious Diseases and Vaccines, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Fiona R M
authors.initials: FR
authors.lastname: van der Klis
authors.affiliation: Centre for Immunology of Infectious Diseases and Vaccines, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Hester E
authors.initials: HE
authors.lastname: de Melker
authors.affiliation: Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands; Department of Toxicogenomics, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Henk
authors.initials: H
authors.lastname: van Loveren
authors.affiliation: Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors.forename: Riny
authors.initials: R
authors.lastname: Janssen
mesh_terms: D000082:Acetaminophen / Q000494:pharmacology* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000209:etiology; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007110:Immunity, Active / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D014611:Vaccination / Q000379:methods; D055815:Young Adult
chemical_list: D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D000082:Acetaminophen