Saha, Sumona

Abstract Background In infants that were exposed to biologics in utero, gastroenterology societal guidelines have either recommended against administration of the live rotavirus vaccine until 6-12 months of age or until serum biologic levels are undetectable. We performed a systematic review to evaluate the safety of rotavirus vaccination in biologic-exposed infants. Methods EMBASE, PubMed, Scopus, and Cochrane databases were searched from 2006 to 2024 for original data reporting on the safety of rotavirus vaccination in infants that were exposed to anti-tumor necrosis factors (TNFs) (ie, infliximab, adalimumab, golimumab, certolizumab) and non-TNF biologics (ie, vedolizumab, ustekinumab, rizankizumab, mirikizumab) in utero. Results A database search yielded 7185 screening results of which 10 studies met inclusion criteria. There were over 300 instances of rotavirus vaccination in biologic-exposed infants (n = 162 exposed to anti-TNFs, n = 142 exposed to non-TNF biologics). Biologic-exposed infants were not at an increased risk of severe adverse events or adverse events of any severity related to rotavirus vaccination. Conclusions Administration of the live rotavirus vaccine appears to be safe in biologic-exposed infants. As such, with careful examination of the risks and benefits, there may be a role for rotavirus vaccination in this population.

Abstract Background Some patients with inflammatory bowel disease (IBD) on immunosuppressive therapies may have a blunted response to certain vaccines, including the messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccines. However, few studies have evaluated the cell-mediated immune response (CMIR), which is critical to host defense after COVID-19 infection. The aim of this study was to evaluate the humoral immune response and CMIR after mRNA COVID-19 vaccination in patients with IBD. Methods This prospective study (HERCULES [HumoRal and CellULar initial and Sustained immunogenicity in patients with IBD] study) evaluated humoral immune response and CMIR after completion of 2 doses of mRNA COVID-19 vaccines in 158 IBD patients and 20 healthy control (HC) subjects. The primary outcome was the CMIR to mRNA COVID-19 vaccines in patients with IBD. The secondary outcomes were a comparison of (1) the CMIR in patients with IBD and HC subjects, (2) CMIR and humoral immune response in all participants, and (3) correlation between CMIR and humoral immune response. Results The majority (89%) of patients with IBD developed a CMIR, which was not different vs HC subjects (94%) (P = .6667). There was no significant difference (P = .5488) in CMIR between immunocompetent (median 255 [interquartile range, 146-958] spike T cells per million peripheral blood mononuclear cells) and immunosuppressed patients (median 377 [interquartile range, 123-1440]). There was no correlation between humoral and cell-mediated immunity after vaccination (P = .5215). In univariable analysis, anti-tumor necrosis factor therapy was associated with a higher CMIRs (P = .02) and confirmed in a multivariable model (P = .02). No other variables were associated with CMIR. Conclusions Most patients with IBD achieved CMIR to a COVID-19 vaccine. Future studies are needed evaluating sustained CMIR and clinical outcomes.