Jacek Wysocki1, Kimberly J Center2, Jerzy Brzostek3, Ewa Majda-Stanislawska4, Henryk Szymanski5, Leszek Szenborn6, Hanna Czajka7, Barbara Hasiec8, Jerzy Dziduch9, Teresa Jackowska10, Anita Witor11, Elżbieta Kopińska12, Ryszard Konior13, Peter C Giardina14, Vani Sundaraiyer15, Scott Patterson16, William C Gruber17, Daniel A Scott18, Alejandra Gurtman19. 1. Department of Preventive Medicine, Poznań University of Medical Sciences, ul. Smoluchowskiego 11, 60-179 Poznań, Poland. Electronic address: jawysocki@pro.onet.pl. 2. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: kimberly.center@pfizer.com. 3. Zespol Opieki Zdrowotnej w Debicy, Krakowska 91, 39-200 Debica, Poland. Electronic address: jerzy_br@poczta.onet.pl. 4. Department of Pediatric Infectious Diseases, Medical University of Lodz, Al. Kościuszki 4, 90-419 Lodz, Poland. Electronic address: emajda@lodz.home.pl. 5. NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak, Trzebnicka 37, 55-120 Oborniki Slaskie, Poland. Electronic address: henryktomasz@poczta.onet.pl. 6. Department of Pediatric Infectious Diseases, Wroclaw Medical University, ul. Chałubińskiego 2-2a, 50-368 Wroclaw, Poland. Electronic address: leszek.szenborn@am.wroc.pl. 7. Indywidualna Specjalistyczna Praktyka Lekarska, Braci Kiemliczow 14, 30-389 Krakow, Poland. Electronic address: hanna.czajka@onet.pl. 8. NZOZ Praktyka Lekarza Rodzinnego, ul. Weteranów 46, 20-044 Lublin, Poland. Electronic address: bhasiec@wp.pl. 9. SPZOZ Lubartow Oddzial Pediatryczny, ul. Cicha 14, 21-100 Lubartow, Poland. Electronic address: jurekad@tlen.pl. 10. Department of Pediatrics, Medical Center of Postgraduate Education, ul. Marymoncka 99/103, 01-813 Warsaw, Poland. Electronic address: tjackowska@cmkp.edu.pl. 11. NZLA Michalkowice Jaroszy i Partnerzy, Kościelna 32, 41-103 Siemianowice, Slaskie, Poland. Electronic address: adamanita@interia.pl. 12. Physicians Practice Group Family Specialist Outpatient Clinic, Szosa Chelminska 54B/4, 87-100 Torun, Poland. Electronic address: ela.kopinska@gmail.com. 13. NZOZ "Praktimed" sp. z o.o., Strzelców 15, 31-422 Krakow, Poland. Electronic address: rkonior@szpitaljp2.krakow.pl. 14. Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: peter.giardina@pfizer.com. 15. inVentiv Health Clinical, LLC, 504 Carnegie Center, Princeton, NJ 08540, USA. Electronic address: Vani.Sundaraiyer@inventivhealth.com. 16. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: Scott.Patterson@pfizer.com. 17. Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: Bill.Gruber@pfizer.com. 18. Pfizer Vaccine Research, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: dan.scott@pfizer.com. 19. Pfizer Vaccine Research, 401 N. Middletown Rd, Pearl River, NY 10965, USA. Electronic address: Alejandra.Gurtman@pfizer.com.
Abstract
OBJECTIVE: Prophylactic 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. METHODS: Subjects 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 12months of age. At 5 and 13months, immune responses were evaluated versus responses in controls who received no prophylaxis. RESULTS: After 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. CONCLUSIONS:Prophylactic 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: NCT01392378https://clinicaltrials.gov/ct2/show/NCT01392378?term=NCT01392378&rank=1.
RCT Entities:
OBJECTIVE: Prophylactic 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. METHODS: Subjects 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 12months of age. At 5 and 13months, immune responses were evaluated versus responses in controls who received no prophylaxis. RESULTS: After 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. CONCLUSIONS: Prophylactic 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: NCT01392378https://clinicaltrials.gov/ct2/show/NCT01392378?term=NCT01392378&rank=1.
Authors: Eng Eong Ooi; Arti Dhar; Richard Petruschke; Camille Locht; Philippe Buchy; Jenny Guek Hong Low Journal: NPJ Vaccines Date: 2022-03-02 Impact factor: 9.399