Evaluation of Safety and Immunogenicity of BNT162B2 mRNA COVID-19 Vaccine in IBD Pediatric Population with Distinct Immune Suppressive Regimens
Nicola Cotugno,
Enrica Franzese,
Giulia Angelino,
Donato Amodio,
Erminia Francesca Romeo,
Francesca Rea,
Simona Faraci,
Renato Tambucci,
Elisa Profeti,
Emma Concetta Manno,
Veronica Santilli,
Gioacchino Andrea Rotulo,
Chiara Pighi,
Chiara Medri,
Elena Morrocchi,
Luna Colagrossi,
Giuseppe Rubens Pascucci,
Diletta Valentini,
Alberto Villani,
Paolo Rossi,
Paola De Angelis,
Paolo Palma
Affiliations
Nicola Cotugno
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Enrica Franzese
The School of Pediatrics, University of Rome “Tor Vergata”, 00133 Rome, Italy
Giulia Angelino
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Donato Amodio
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Erminia Francesca Romeo
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Francesca Rea
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Simona Faraci
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Renato Tambucci
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Elisa Profeti
The School of Pediatrics, University of Rome “Tor Vergata”, 00133 Rome, Italy
Emma Concetta Manno
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Veronica Santilli
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Gioacchino Andrea Rotulo
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Chiara Pighi
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Chiara Medri
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Elena Morrocchi
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Luna Colagrossi
Microbiology and Diagnostic Immunology Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Giuseppe Rubens Pascucci
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Diletta Valentini
Pediatric Unit, Pediatric Emergency Department (DEA), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Alberto Villani
Chair of Pediatrics, Department of Systems Medicine, University of Rome “Tor Vergata”, 00185 Rome, Italy
Paolo Rossi
Chair of Pediatrics, Department of Systems Medicine, University of Rome “Tor Vergata”, 00185 Rome, Italy
Paola De Angelis
Digestive Endoscopy and Surgery Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Paolo Palma
Research Unit of Clinical Immunology and Vaccinology, Academic Department of Pediatrics (DPUO), Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
Patients affected by Inflammatory Bowel Disease (IBD) present higher risk for infection and suboptimal response upon vaccination. The immunogenicity of SARS-CoV2 vaccination is still largely unknown in adolescents or young adults affected by IBD (pIBD). We investigated the safety and immunogenicity of the BNT162B2 mRNA COVID-19 vaccine in 27 pIBD, as compared to 30 healthy controls (HC). Immunogenicity was measured by anti-SARS-CoV2 IgG (anti-S and anti-trim Ab) before vaccination, after 21 days (T21) and 7 days after the second dose (T28). The safety profile was investigated by close monitoring and self-reported adverse events. Vaccination was well tolerated, and short-term adverse events reported were only mild to moderate. Three out of twenty-seven patients showed IBD flare after vaccination, but no causal relationship could be established. Overall, pIBD showed a good humoral response upon vaccination compared to HC; however, pIBD on anti-TNFα treatment showed lower anti-S Ab titers compared to patients receiving other immune-suppressive regimens (p = 0.0413 at first dose and p = 0.0301 at second dose). These data show that pIBD present a good safety and immunogenicity profile following SARS-CoV-2 mRNA vaccination. Additional studies on the impact of specific immune-suppressive regimens, such as anti TNFα, on immunogenicity should be further investigated on larger cohorts.
