Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: Aim: To determine the vaccination rates in pediatric immunosuppression-dependent inflammatory bowel disease (IBD) and review the safety and efficacy of vaccinations in this population. Methods: The electronic medical records from October 2009 to December 2015 of the patients diagnosed with IBD at 10 years of age or younger and prescribed antitumor necrosis factor alpha (anti-TNF-alfa) therapy were reviewed for clinical history, medication history, vaccination history, and hepatitis B and varicella titers. The report discussing vaccination response in IBD patients were identified through search of the database and reviewed using the key words "inflammatory bowel disease", "immunization", "vaccination", "pneumococcal", "varicella", and "hepatitis B". Non-human and non-English language studies were excluded. Search results were reviewed by authors to select articles that addressed safety and efficacy of immunizations in inflammatory bowel disease. Results: A total of 51 patients diagnosed with IBD prior to the age of 10 and receiving anti-TNF-alfa therapy were identified. The age at diagnosis for these 51 patients ranged from 15 month to 9 years of age. Sixty-seven percent (34/51) had documentation of a completed primary vaccination series. Thirty-three percent of patients (17/51) had incomplete or no documentation of vaccinations. Sixteen case reports, cohort studies, cross-sectional studies, and randomized trials were determined through review of the literature to describe the safety and efficacy of hepatitis B, pneumococcal, and varicella immunizations in adult and pediatric patients with IBD. These studies showed that patients safely tolerated the vaccines without significant adverse effects. Importantly, IBD patients receiving immunosuppressive medications, particularly anti-TNF-alfa treatment, have decreased vaccine response compared to controls. However, the majority of patients were still able to achieve protective levels of specific antibodies. Hepatitis B (HepB) serology had been recommended prior to initiation of immunosuppressive therapies due to the risk of reactivation of latent HepB infection with the start of treatment. Additionally, it was recommended that non-immune HepB patients receive a vaccine booster. In the retrospective study, serology specifically evaluating HepB surface antibody showed that 67% (27/44 patients who had documented serology) were non-responders to their initial hepatitis b vaccine (recombinant) (manufacturer unknown) series. Six of the non-responders (6/27) had documentation of hepatitis b vaccine (recombinant) (manufacturer unknown) booster receipt and post-vaccination titers drawn. Four of the 6 achieved seroprotection following the booster vaccine. Eighteen of the non-responders (18/27) either did not receive hepatitis b vaccine (recombinant) (manufacturer unknown) booster or did not have repeat HepB titers measured. This report refers to the 27 pediatric patients of unknown age and gender with immunosuppression-dependent IBD. The patients' historical drug included antitumor necrosis factor alpha (anti-TNF-alfa) therapy. On unknown dates, the patients started therapy with hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, lot # and route unknown) for prophylaxis. On unknown dates, serology specifically evaluating HepB surface antibody showed that the patients were non-responders to their initial vaccine of hepatitis b vaccine (recombinant) (manufacturer unknown) series. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).