Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Pediatric Patients with Inflammatory Bowel Disease.
BACKGROUND
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 conjugate vaccine (PCV13) in IBD pediatric patients compared with healthy controls.


METHODS
This was a multicenter, prospective, and controlled study on children and adolescents aged 5 to 18 years with IBD with no history of pneumococcal immunization. The subjects for the study belonged to one of the following groups: patients with IBD on no immunosuppressive therapy (group A), those on tumor necrosis factor agents or immunomodulators (group B), and healthy controls (group C). The study population received 1 intramuscular injection of PCV13. The primary outcome measure was adequate vaccine response defined as postvaccination titer ≥0.35 μg/mL to all 13 serotypes. Geometric mean titers and geometric mean titer rises were measured for all serotypes. The evidence of local and systemic adverse effects for 5 days after the vaccine was registered.


RESULTS
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 patients with IBD and controls measured 4 to 8 weeks after vaccination (90.4% versus 96.5%, P = 0.5281). Children in group A had higher geometric mean titer rises than children in group B (P = 0.0369). There were no serious adverse events related to PCV13 during the study.


CONCLUSIONS
PCV13 is both immunogenic and safe in pediatric patients with IBD.
*Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Poland; †Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland; ‡Department of Pediatrics, Gastroenterology and Nutrition, Polish-American Children's Hospital, Jagiellonian University Medical College, Krakow, Poland; §Department of Pediatric Gastroenterology, Hepatology and Nutrition, Medical University of Gdansk, Gdansk, Poland; ‖Department of Pediatrics, Medical University of Silesia, Katowice, Poland; ¶Department of Pediatrics, Gastroenterology and Nutrition, Wroclaw Medical University, Wroclaw, Poland; and **Department of Microbiology and Clinical Immunology, The Children's Memorial Health Institute, Warsaw, Poland.
Aleksandra
A
Banaszkiewicz
Brygida
B
Targońska
Kinga
K
Kowalska-Duplaga
Katarzyna
K
Karolewska-Bochenek
Agnieszka
A
Sieczkowska
Agnieszka
A
Gawrońska
Urszula
U
Grzybowska-Chlebowczyk
Elżbieta
E
Krzesiek
Izabella
I
Łazowska-Przeorek
Maria
M
Kotowska
Edyta
E
Sienkiewicz
Jarosław
J
Walkowiak
Hanna
H
Gregorek
Andrzej
A
Radzikowski
Piotr
P
Albrecht
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D000069443:Heptavalent Pneumococcal Conjugate Vaccine / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D015212:Inflammatory Bowel Diseases / Q000276:immunology / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D013296:Streptococcus pneumoniae / Q000276:immunology*; D014611:Vaccination / Q000379:methods*
D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007155:Immunologic Factors