Arijit Sil1, Mandyam D Ravi2, Badri N Patnaik3, Mandeep S Dhingra4, Martin Dupuy5, Dulari J Gandhi6, Sangappa M Dhaded7, Anand P Dubey8, Ritabrata Kundu9, Sanjay K Lalwani10, Jugesh Chhatwal11, Leni G Mathew12, Madhu Gupta13, Shiv D Sharma14, Sandeep B Bavdekar15, Soumya P Rout3, Midde V Jayanth3, Naveena A D'Cor3, Somnath A Mangarule3, Suresh Ravinuthala3, Jagadeesh Reddy E3. 1. Shantha Biotechnics Private Limited - A Sanofi Company, Hyderabad, India. Electronic address: arijit.sil@sanofi.com. 2. Dept. of Pediatrics, JSS Medical College, Mysore, India. 3. Shantha Biotechnics Private Limited - A Sanofi Company, Hyderabad, India. 4. Sanofi Pasteur, Swiftwater, USA. 5. Sanofi Pasteur, Marcy-l'Étoile, France. 6. Dept. of Pediatrics, SBKS MI & RC, Sumandeep Vidyapeeth, Vadodara, India. 7. Dept. of Pediatrics, KLE University's, Jawaharlal Nehru Medical College, Belagavi, India. 8. Dept. of Pediatrics, Maulana Azad Medical College, Delhi, India. 9. Dept. of Pediatrics, Institute of Child Health, Kolkata, India. 10. Dept. of Pediatrics, Bharati Vidyapeeth Deemed University Medical College, Pune, India. 11. Dept. of Pediatrics, Christian Medical College, Ludhiana, India. 12. Dept. of Pediatrics, Christian Medical College, Vellore, India. 13. Dept. of Community Medicine, School of Public Health, Post Graduate Institute of Medical Education & Research, Chandigarh, India. 14. Dept. of Pediatrics, Sawai Man Singh Medical College, Jaipur, India. 15. Dept. of Pediatrics, Topiwala National Medical College and BYL Nair Ch. Hospital, Mumbai, India.
Abstract
BACKGROUND: Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever. METHODS: Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups. RESULTS: Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups. CONCLUSION: The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872)].
BACKGROUND: Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever. METHODS: Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups. RESULTS: Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups. CONCLUSION: The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872)].
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
Authors: S Mangarule; S Prashanth; A Kawade; M D Ravi; I V Padmavathi; S Palkar; V N Tripathi; R Singh; M Maurya; M Mitra; R S Shetty; R Z Kompithra; S M Dhaded; V Epari; A Moureau; M V Jayanth; K Varghese; S Ravinuthala; D Kukian; B N Patnaik; F Noriega Journal: Vaccine X Date: 2022-09-13