Effects of prophylactic and therapeutic paracetamol treatment during vaccination on hepatitis B antibody levels in adults: two open-label, randomized controlled trials

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 simila...

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Bibliographic Details
Published in:	PloS one 2014-06, Vol.9 (6), p.e98175
Main Authors:	Doedée, Anne M C M, Boland, Greet J, Pennings, Jeroen L A, de Klerk, Arja, Berbers, Guy A M, van der Klis, Fiona R M, de Melker, Hester E, van Loveren, Henk, Janssen, Riny
Format:	Article
Language:	eng
Subjects:	Acetaminophen Acetaminophen - pharmacology Acetaminophen - therapeutic use Adolescent Adult Adults Analgesics Analysis Asthma Dioxins Female Fever Fever - drug therapy Fever - etiology Gene expression Hepatitis Hepatitis B Hepatitis B - immunology Hepatitis B - prevention & control Hepatitis B Antibodies - immunology Hepatitis B vaccine Hepatitis B vaccines Hepatitis B Vaccines - adverse effects Hepatitis B Vaccines - immunology Hepatitis B Vaccines - therapeutic use Hepatitis B virus Hepatitis B virus - immunology Humans Immunity, Active - drug effects Immunology Infants Infectious diseases Male Medicine and health sciences Middle Aged Pain Paracetamol Public health Randomization Research and Analysis Methods Studies Vaccination Vaccination - methods Vaccines Young Adult Young adults
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Summary:	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. Controlled-Trials.com ISRCTN03576945.
ISSN:	1932-6203 1932-6203