P292 Immunogenicity of 13-valent pneumococcal conjugated vaccine in pediatric patients with inflammatory bowel disease
A. Banaszkiewicz*1, B. Targonska2, K. Kowalska-Duplaga3, K. Karolewska-Bochenek1, A. Sieczkowska4, A. Gawronska1, U. Grzybowska-Chlebowczyk5, E. Krzesiek6, I. Lazowska-Przeorek1, M. Kotowska1, E. Sienkiewicz1, J. Walkowiak2, H. Gregorek7, A. Radzikowski1, P. Albrecht1
1Medical University of Warsaw, Dept. of Pediatric Gastroenterology and Nutrition, Warsaw, Poland, 2Poznan University of Medical Sciences, Dept. of Pediatric Gastroenterology and Metabolic Diseases, Poznan, Poland, 3Jagiellonian University Medical College, Department of Pediatrics, Gastroenterology and Nutrition, Krakow, Poland, 4Medical University of Gdansk, Department of Pediatric Gastroenterology, Hepatology and Nutrition, Gdansk, Poland, 5Medical University of Silesia, Department of Pediatrics, Gastroenterology Unit, Katowice, Poland, 6Wroclaw Medical University, Department of Pediatrics, Gastroenterology and Nutrition, Wroclaw, Poland, 7The Children's Memorial Health Institute, Department of Microbiology and Clinical Immunology, Warsaw, Poland
There are only a few studies on immune response to pneumococcal vaccines in patients with inflammatory bowel disease (IBD); all of them assessed polysaccharide vaccines only. The aim of the study was to evaluate the immunogenicity and safety of 13-valent pneumococcal conjugated vaccine (PCV13) in IBD pediatric patients compared with healthy controls.
This was a multi-center, prospective and controlled study on children and adolescents aged 5-18 years with IBD with no history of pneumococcal immunization or documented pneumococcal infection. The subjects for the study belonged to one of the following groups: patients with IBD on no immunosuppressive therapy (Group A), those on TNF agents or immunomodulators (Group B) and healthy controls (Group C). The study population received one intramuscular injection of PCV13. The primary outcome measure was adequate vaccine response defined as post-vaccination titer greater than or equal to 0.35 µg/mL to all 13 serotypes. Geometric mean titers and geometric mean titer rises (GMTRs) were measured for all serotypes. The evidence of local and systemic adverse effects for five days after the vaccine was registered.
A total of 178 subjects (122 patients and 56 controls) completed the study course. There was no significant difference in the rate of adequate vaccine response between IBD patients and controls measured 4-8 weeks after vaccination (90.4% vs. 96.5%, p=0.5281). Children in group A had higher GMTRs than children in group B (p = 0.0369). There were no serious adverse events related to PCV13 during the study.
PCV13 is both immunogenic and safe in pediatric patients with IBD.