A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations |
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| Institution: | 1. Department of Preventive Medicine, Poznań University of Medical Sciences, ul. Smoluchowskiego 11, 60-179 Poznań, Poland;2. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA;3. Zespol Opieki Zdrowotnej w Debicy, Krakowska 91, 39-200 Debica, Poland;4. Department of Pediatric Infectious Diseases, Medical University of Lodz, Al. Ko?ciuszki 4, 90-419 Lodz, Poland;5. NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak, Trzebnicka 37, 55-120 Oborniki Slaskie, Poland;6. Department of Pediatric Infectious Diseases, Wroclaw Medical University, ul. Cha?ubińskiego 2-2a, 50-368 Wroclaw, Poland;7. Indywidualna Specjalistyczna Praktyka Lekarska, Braci Kiemliczow 14, 30-389 Krakow, Poland;8. NZOZ Praktyka Lekarza Rodzinnego, ul. Weteranów 46, 20-044 Lublin, Poland;9. SPZOZ Lubartow Oddzial Pediatryczny, ul. Cicha 14, 21-100 Lubartow, Poland;10. Department of Pediatrics, Medical Center of Postgraduate Education, ul. Marymoncka 99/103, 01-813 Warsaw, Poland;11. NZLA Michalkowice Jaroszy i Partnerzy, Ko?cielna 32, 41-103 Siemianowice, Slaskie, Poland;12. Physicians Practice Group Family Specialist Outpatient Clinic, Szosa Chelminska 54B/4, 87-100 Torun, Poland;13. NZOZ “Praktimed” sp. z o.o., Strzelców 15, 31-422 Krakow, Poland;14. Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA;15. inVentiv Health Clinical, LLC, 504 Carnegie Center, Princeton, NJ 08540, USA |
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| Abstract: | ObjectiveProphylactic antipyretic use during pediatric vaccination is common. This study assessed whether paracetamol or ibuprofen prophylaxis interfere with immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13) given concomitantly with the combined DTaP/HBV/IPV/Hib vaccine.MethodsSubjects received prophylactic paracetamol or ibuprofen at 0, 6–8, and 12–16 h after vaccination, or 6–8 and 12–16 h after vaccination at 2, 3, 4, and 12 months of age. At 5 and 13 months, immune responses were evaluated versus responses in controls who received no prophylaxis.ResultsAfter the infant series, paracetamol recipients had lower levels of circulating serotype-specific pneumococcal anticapsular immunoglobulin G than controls, reaching significance (P < 0.0125) for 5 serotypes (serotypes 3, 4, 5, 6B, and 23F) when paracetamol was started at vaccination. Opsonophagocytic activity assay (OPA) results were similar between groups. Ibuprofen did not affect pneumococcal responses, but significantly (P < 0.0125) reduced antibody responses to pertussis filamentous hemagglutinin and tetanus antigens after the infant series when started at vaccination. No differences were observed for any group after the toddler dose.ConclusionsProphylactic antipyretics affect immune responses to vaccines; these effects vary depending on the vaccine, antipyretic agent, and time of administration. In infants, paracetamol may interfere with immune responses to pneumococcal antigens, and ibuprofen may reduce responses to pertussis and tetanus antigens. The use of antipyretics for fever prophylaxis during infant vaccination merits careful consideration.ClinicalTrials.gov identifier: NCT01392378 https://clinicaltrials.gov/ct2/show/NCT01392378?term=NCT01392378&rank=1 |
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| Keywords: | Pneumococcal conjugate vaccine Immune response Antipyretic Ibuprofen Paracetamol Infant |
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