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Background and Aims: Patients with inflammatory bowel disease (IBD) are at an increased risk for vaccine-preventable diseases, such as herpes zoster (HZ). The aim of this study was to determine whether complications of HZ are more frequent in patients with IBD than in non-IBD controls., Methods: This was a retrospective, cohort study using the Optum Research Database. Patients with IBD were matched 1:1 to non-IBD controls based on age, sex, and index year, which was defined as the diagnosis of HZ. We then identified the complications of HZ that occurred up to 90 days after the index date. We compared patients with IBD with non-IBD controls and evaluated the 90-day risk of HZ complications. We used a composite primary outcome for any HZ complication. Secondary outcomes were risk factors for complications., Results: Four thousand seven fifty-six patients with IBD met the inclusion criteria and were matched to the controls. Patients with IBD were more likely to have complications of HZ than controls [738 (15.52%) vs. 595 (12.51%), p < 0.0001]. Patients with IBD with higher comorbidity scores were more likely to develop complications (1.86 vs. 1.18 p < 0.0001). In the logistic regression analysis of patients with IBD having a higher comorbidity score, above 50 years of age, on anti-TNF or corticosteroids were all at increased risk of a complication of HZ., Conclusion: Patients with IBD are more likely to have complications of HZ than controls. Efforts are needed to increase HZ vaccine uptake to reduce the morbidity of HZ., (Copyright © 2024. Published by Elsevier Inc.)

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., (© The Author(s) 2024. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Live vaccines are contraindicated in patients on immunosuppressive therapy. We conducted a retrospective study evaluating the administration of a live vaccine in patients with IBD on immunosuppressive therapy. The primary outcome was to determine clinical or disseminated disease episodes within three months of vaccine administration in patients who inadvertently received a live vaccine. Thirty-five patients met the inclusion criteria. Twenty-two received the measles, mumps, and varicella (MMR) vaccine, nine received the live zoster vaccine, and one received the varicella vaccine (VAR). Three patients received both the MMR and VAR. The majority of our cohort (20, 57 %) were on anti-tumor necrosis factor, followed by azathioprine (12, 34 %) and vedolizumab (3, 9 %). Although live vaccines are contraindicated in patients on immunosuppressive therapy, none of the patients in this study reported any infections after inadvertent immunization. Further studies are required to address the safety and effectiveness of live vaccine administration in this population., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Freddy Caldera has received research support from Takeda Pharmaceuticals, Janssen and Novavax. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene. Dr. Farraye is a consultant for AbbVie, Avalo Therapeutics, BMS, Braintree Labs, Fresenius Kabi, GI Reviewers, GSK, Iterative Health, Janssen, Pfizer, Sandoz Immunology, Sebela and Viatris. He sits on a DSMB for Lilly Pharmaceuticals. Dr. Hayney is a consultant for GSK Vaccines and Seqirus, and has received research support from Novavax, Takeda Pharmaceuticals, and Dynavax., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

This prospective study enrolled healthcare workers (HCWs) who were nonresponders following at least 5 doses of aluminum-adjuvanted hepatitis B vaccine who received the 2-dose Heplisav-B (HepB-CpG) (Dynavax Technologies Corporation, Emeryville, CA) series. After 2 doses of HepB-CpG, 43/47 (91%) participants, and with 1 dose, 41/49 (84%) responded. HepB-CpG could be the preferred vaccine in HCW nonresponders. Clinical Trials Registration. Clinicaltrials.gov NCT04456504., Competing Interests: Potential conflicts of interest. Dr. Caldera has received research support from Novavax and Takeda Pharmaceuticals. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene. Dr. Hayney received research support from Novavax and Takeda Pharmaceuticals. She has served as a consultant and speaker for GSK vaccines. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Healthy populations have high rates of sustained vaccine-induced seroprotection to hepatitis B virus, but previous studies in immunosuppressed patients with inflammatory bowel disease (IBD) have shown suboptimal seroprotection rates. A challenge dose of hepatitis B vaccine (HepB) is recommended in previously vaccinated individuals who are seronegative to elicit an anamnestic response and determine if they are seroprotected. The aim of our study was to determine sustained seroprotection rates to hepatitis B vaccine (HepB) in patients with IBD., Methods: This was a single-center prospective study of patients with IBD previously vaccinated with a three dose HepB series. Patients had a hepatitis B surface antibody (anti-HBs) drawn; if it was below 10 mIU/mL, they received a challenge dose of the HepB vaccine to assess for anamnestic response and sustained seroprotection. The primary outcome was to determine the rate of sustained seroprotection (anti-HBs ≥ 10)., Results: A total of 168 patients met inclusion criteria, mean age 35.7 years ± 13.6 standard deviation (SD). Initially 120 (71.4%) had anti-HBs ≥ 10 mIU/mL, with median anti-HBs of 37 mIU/mL (interquartile range 0-234); 48 (28.6%) needed a challenge dose, of which 34 responded with anti-HBs ≥ 10 mIU/mL. In total, 154 (91.7%) demonstrated sustained seroprotection to HepB. Those not seroprotected were more likely to have been vaccinated on immunosuppressive therapy or after their diagnosis of IBD., Conclusions: Most vaccinated patients with IBD maintain sustained seroprotection to HepB despite prolonged exposure to immunosuppression. This contradicts prior studies and shows that immunosuppression does not lead to loss of seroprotection., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: There is evidence that SARS-CoV2 infection can increase the risk of herpes zoster (HZ) in the general population. However, the risk in patients with inflammatory bowel disease (IBD) is not known., Methods: The TriNetX database was utilized to conduct a retrospective cohort study in patients with IBD after SARS-CoV2 infection and patients without a SARS-CoV2 infection (IBD control cohort). The primary outcome was to evaluate the risk of HZ between the 2 cohorts. One-to-one (1:1) propensity score matching was performed for demographic parameters, HZ risk factors and IBD medications between the 2 cohorts. Adjusted odds ratio (aOR) with 95% confidence interval (CI) were calculated., Results: After propensity score matching, patients with IBD with a SARS-CoV2 infection were at an increased risk for HZ (aOR, 2.16; 95% CI, 1.53-3.04) compared with IBD control cohort in the pre-COVID-19 vaccine era. There was no difference in the risk (aOR, 0.87; 95% CI, 0.44-1.75) of a composite outcome of HZ complications (hospitalization, post-herpetic neuralgia, and neurologic complications) between the 2 cohorts. The IBD SARS-CoV2 cohort was also at an increased risk for HZ (aOR, 3.04; 95% CI, 1.48-6.24) compared with IBD control cohort in the postvaccine era. However, the risk of HZ in the postvaccine era was decreased (aOR, 0.45; 95% CI, 0.27-0.76) compared with IBD SARS-CoV2 cohort in the prevaccine era., Conclusions: Our study showed that SARS-CoV2 infection is associated with an increased risk of HZ in patients with IBD., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Recombinant zoster vaccine [RZV] reduces the short-term risk of herpes zoster [HZ] in patients with inflammatory bowel disease [IBD]. However, there is lack of data regarding the long-term effectiveness in this population., Methods: A retrospective cohort study was conducted in adults ≥50 years old using TriNetX database between patients with IBD who received two doses of RZV [IBD-RZV cohort] and patients who did not receive RZV [IBD control cohort]. The primary outcome was risk of incident HZ. One-to-one propensity score matching was performed for demographic parameters, comorbid conditions, and IBD medications. Risk was expressed as adjusted odds ratio [aOR] with 95% confidence intervals [CI]., Results: The IBD-RZV cohort [n = 5489; mean age 63.2 ± 9.1 years; 57.2% females] was identified with a mean follow-up of 900.9 days. IBD-RZV cohort had a lower risk of HZ [aOR 0.44, 95% CI 0.32-0.62] compared with IBD control cohort. The risk of HZ was lower in patients aged 50-65 years [aOR 0.41, 95% CI 0.25-0.68] and patients >65 years [aOR 0.64, 95% CI 0.42-0.96]. There was a lower risk of HZ in patients with ulcerative colitis [aOR 0.41, 95% CI 0.27-0.63] and Crohn's disease [aOR 0.44, 95% CI 0.26-0.74] in the IBD-RZV cohort compared with IBD control cohort., Conclusion: RZV is associated with a lower long-term risk of HZ in patients ≥50 years old with IBD. Given the widespread availability and safety of RZV, more effective vaccination strategies are needed to improve RZV use in this high-risk population., (© The Author(s) 2024. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Introduction: Studies suggest that the generation of durable T-cell immunity following coronavirus disease 2019 (COVID-19) vaccination protects against severe disease. The aim of this study was to measure cell-mediated immune response (CMIR) 1-2 months and 6 months after a third dose of a COVID-19 mRNA vaccine., Methods: This prospective study (HumoRal and CellULar initial and Sustained immunogenicity in patients with inflammatory bowel disease [IBD]) evaluated CMIR at 28-65 days (t 1 ) after dose 2, 28-65 days (t 2 ) (n = 183) and 6 months (±45 days) (t 3 ) (n = 167) after a third dose of an mRNA COVID-19 vaccine. A small cohort had blood sample available 28-65 days (t 4 ) (n = 55) after a fourth dose. Primary outcomes were CMIR at (t 2 ) and (t 3 ). Secondary outcomes included the effect of immunosuppressing IBD medications on CMIR and response at (t 4 )., Results: All patients had measurable CMIR at all time points. CMIR increased at t 2 compared with that at t 1 (median 1,467 responding cells per million (interquartile range [IQR] 410-5,971) vs 313 (94-960) P < 0.001). There was no significant waning in t 2 vs t 3 or significant boosting at t 4 . Those on anti-tumor necrosis factor monotherapy had a higher CMIR compared with those not on this therapy at t 2 (4,132 [IQR 1,136-8,795] vs 869 [IQR 343-3,221] P < 0.001) and t 3 (2,843 [IQR 596-6,459] vs 654 [IQR 143-2,067] P < 0.001). In univariable analysis, anti-tumor necrosis factor monotherapy was associated with a higher CMIR at t 2 ( P < 0.001) and t 3 ( P < 0.001) and confirmed in a multivariable model ( P < 0.001)., Discussion: A third dose of a COVID-19 vaccine boosts CMIR, and the response is sustained in patients with IBD., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Background and Aims: Racial and ethnic disparities exist in the treatment of IBD. These disparities exist in adult vaccine uptake among the general population and may extend to patients with IBD. The primary aim of this study was to determine whether racial, ethnic, or geographic disparities existed in influenza vaccine uptake among patients with IBD., Methods: We performed a multicenter, retrospective cohort study evaluating adult vaccine uptake among patients with IBD seen at two tertiary referral centers between September 2019 and February 2020. The primary outcome was to determine if racial/ethnic and geographic disparities existed in influenza vaccine uptake for the two prior seasons. Our secondary outcomes were to determine if disparities existed for pneumococcal, zoster, or hepatitis B vaccines., Results: Among the 2453 patients who met the inclusion criteria, most identified as non-Hispanic White (89.9%), were on immunosuppressive therapy (74.5%), and received the influenza vaccine in both seasons (56.0%). Older age (prevalence ratio (PR) 0.98; 95% confidence interval (95%CI) 0.98-0.99; P  < .001) and non-Hispanic White patients (PR 0.76, 95%CI 0.59-0.98, P  < 0.03) were significantly more likely to be immunized. Black patients (PR 1.37; 95%CI 1.18-1.59; P  < .001) and those living in underserved geographic areas (PR 1.35; 95%CI 1.17-1.56; P  < 0.001) were less likely to be immunized. Racial/ethnic and geographic disparities were identified for pneumococcal, zoster, and hepatitis B vaccine uptake., Conclusions: Racial and ethnic vaccination uptake disparities exist among patients with IBD; patients from medically underserved areas are also vulnerable to these disparities Studies identifying patient, provider, and system-level opportunities to address these disparities are needed., Competing Interests: F.C. has received research support from Takeda Pharmaceuticals. He has been a consultant for Takeda, Arena Pharmaceuticals, GSK, and Celgene. F.A.F. is a consultant for AbbVie, BMS, Braintree Labs, Fresenius Kabi, GI Reviewers, GSK, IBD Educational Group, Iterative Health, Janssen, Pharmacosmos, Pfizer,Sebela and Viatris. He sits on a DSMB for Eli Lilly. M.S.H. is a consultant for GSK Vaccines and Seqirus and has received research support from Takeda Pharmaceuticals and Dynavax. P.B.P. has been a consultant for Takeda Pharmaceuticals. Guarantor of the article: F.C., D.O., M.S. F.C.—study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, and critical revision of manuscript. M.S.H—study concept and design, acquisition of data, analysis, and interpretation of data, drafting of the manuscript, and critical revision of manuscript. P.B.P.—study concept and design, acquisition of data, and interpretation of data, drafting of the manuscript, and critical revision of manuscript. G.W.—study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, and critical revision of manuscript. F.A.F.—critical revision of manuscript. J.W.—study concept and design and critical revision of manuscript. K.B.—acquisition of data and critical revision of manuscript. A.U.—acquisition of data and critical revision of manuscript. T.L.S.—acquisition of data and critical revision of manuscript. R.S.—acquisition of data and critical revision of manuscript. A.H.—acquisition of data and critical revision of manuscript. L.H.—acquisition of data and critical revision of manuscript. K.E.D.—acquisition of data and critical revision of manuscript. S.D.—acquisition of data and critical revision of manuscript. N.S.—acquisition of data and critical revision of manuscript. K.R.S.—acquisition of data and critical revision of manuscript. R.K.R.—data analysis and critical revision of manuscript. M.A.M.—acquisition of data and critical revision of manuscript. F.O.—statistical analysis., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.)

Introduction: There is a paucity of studies evaluating vaccine uptake in adults with neurological and musculoskeletal medical conditions. We sought to evaluate the rates of COVID-19 vaccine uptake in patients seen in an outpatient rehabilitation clinic., Methods: We conducted a retrospective, single center study of adults seen at an outpatient rehabilitation clinic from December 1, 2020, through June 30, 2021, with an active Wisconsin Immunization Registry record. The primary outcome was completion of a COVID-19 primary vaccine series., Results: Of 1362 patients, 83.3% completed a COVID-19 vaccination series. Younger patients had increased odds of not completing a COVID-19 vaccination series (mean [SD] 46.7 [14.7] vs 54.3 [15.8]; OR 1.03; 95% CI, 1.02-1.04; P  < 0.001). Those who identified as non-White (1.88; 95% CI, 1.16-3.04; P = 0.010) or current smoker (1.85, 95% CI, 1.85-2.79; P = 0.004) had increased odds of not completing a COVID-19 vaccination series. Those who resided in rural ZIP codes (1.81; 95% CI, 1.35-2.43; P  < 0.001), had not received a 2019-2020 influenza vaccine (5.13; 95% CI, 3.79-6.96; P  < 0.001), or had lower comorbidity scores (2.95; 95% CI, 1.98-4.41; P  < 0.001) had higher odds of not completing a COVID-19 vaccination series., Conclusions: There was a high rate of COVID-19 vaccine uptake among patients seen in a rehabilitation clinic, though racial, ethnic, and geographic differences did exist. Further studies are needed to determine why these disparities exist and investigate interventions to increase vaccine uptake in these populations., (Copyright© Board of Regents of the University of Wisconsin System and The Medical College of Wisconsin, Inc.)

Introduction: Patients with inflammatory bowel disease on systemic corticosteroids may be at higher risk of adverse outcomes of COVID-19 infection, and vaccination is an essential preventive measure. Uptake of the original 2-dose COVID-19 messenger RNA (mRNA) primary vaccine series was previously high among patients with inflammatory bowel disease, while uptake of subsequent doses based on interval recommendations made by the Advisory Committee on Immunization Practice remains unknown. Herein, we evaluated uptake of 3 COVID-19 mRNA vaccine doses among patients with inflammatory bowel disease., Methods: A total of 1012 patients were identified; 728 (71.9%) patients received 3 COVID-19 vaccine doses. Multivariable logistic regression revealed that younger age (odds ratio [OR] 1.02; 95% CI, 1.01 - 1.03; P = 0.001), rural status (OR 3.44; 95% CI, 2.17 - 5.56; P < 0.001), underrepresented minority status (OR 3.85; 95% CI, 1.89 - 7.69; P < 0.001), and absence of influenza vaccination (OR 8.17; 95% CI, 5.41 - 12.33; P < 0.001) were significantly associated with incomplete COVID-19 vaccination., Results: Of 1362 patients, 83.3% completed a COVID-19 vaccination series. Younger patients had increased odds of not completing a COVID-19 vaccination series (mean [SD] 46.7 [14.7] vs 54.3 [15.8]; OR 1.03; 95% CI, 1.02-1.04; P  < 0.001). Those who identified as non-White (1.88; 95% CI, 1.16-3.04; P = 0.010) or current smoker (1.85, 95% CI, 1.85-2.79; P = 0.004) had increased odds of not completing a COVID-19 vaccination series. Those who resided in rural ZIP codes (1.81; 95% CI, 1.35-2.43; P  < 0.001), had not received a 2019-2020 influenza vaccine (5.13; 95% CI, 3.79-6.96; P  < 0.001), or had lower comorbidity scores (2.95; 95% CI, 1.98-4.41; P  < 0.001) had higher odds of not completing a COVID-19 vaccination series., Conclusions: Receipt of 3 COVID-19 mRNA vaccine doses is high overall among patients with inflammatory bowel disease. Younger age, underrepresented race/ethnicity, rural status, and lack of influenza vaccination are associated with incomplete COVID-19 vaccination., (Copyright© Board of Regents of the University of Wisconsin System and The Medical College of Wisconsin, Inc.)

Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Recombinant zoster vaccine (RZV) is recommended for all adults ≥19 years of age who are at increased risk for HZ, including patients with inflammatory bowel disease (IBD)., Methods: A Markov model was constructed to compare the RZV cost-effectiveness with no vaccination in patients with Crohn's Disease (CD) and ulcerative colitis (UC). A simulated cohort of 1 million patients was used for each IBD group at ages 18, 30, 40, and 50. The primary objective of this analysis was to compare RZV cost-effectiveness in patients with CD and UC, comparing vaccination to no vaccination., Results: Overall, vaccination is cost-effective for both CD and UC, with the incremental cost-effectiveness ratio (ICERs) below $100,000/quality-adjusted life years (QALY) for all age cohorts. For patients with CD, 30 years of age and older, and those with UC 40 years and older, vaccination was both more effective and less expensive than the non-vaccinated strategy (CD ≥30: ICERs $6183-$24,878 and UC ≥40: ICERs $9163-$19,655). However, for CD patients under 30 (CD 18: ICER $2098) and UC patients under 40 (UC = 18: ICER $11,609, and UC = 30: $1343), costs were greater for vaccinated patients, but there was an increase in QALY. One-way sensitivity analysis of age indicates that cost break-even occurs at age 21.8 for the CD group and 31.5 for the UC group. In probabilistic sensitivity analysis, 92% of both CD and UC simulations indicated that vaccination was preferred., Conclusion: In our model, vaccination with RZV was cost-effective for all adult patients with IBD., (© 2023 John Wiley & Sons Ltd.)

Objective: We developed an Excel-based cost calculator to assess the economic burden of university-based Neisseria meningitidis serogroup B (MenB) outbreaks. Participants: Hypothetical university with 6,354 students. Methods: Total societal costs of outbreak were estimated for three MenB pre-matriculation immunization policies-vaccination required, vaccination recommended, and no vaccine policy-under three different cost assumptions (low/mid-range/high cost). Results: Mid-range cost estimates of an outbreak under "no policy" were $2.60 and $2.70 million (of which 35% were incurred by the university) if targeting all undergraduates for mass vaccination with a two-/three-dose vaccine, respectively. The "required" and "recommended" policies lowered the burden to $2.17-$2.18 million and $2.34-$2.39 million, respectively. For a larger university with 40,000 students, costs were almost $9 million for a two-dose vaccine with "no policy" in place. Conclusions: The economic burden of a university MenB outbreak is substantial, but could be mitigated by a pre-matriculation MenB vaccination requirement or recommendation.

Background: Pharmacy-provided influenza vaccination services have become more prevalent among the older adult population. However, little is known about the characteristics of older adults associated with receiving the influenza vaccination at retail pharmacies and how these associated characteristics have changed., Objective: To examine characteristics of older adults associated with use of retail pharmacy-provided influenza vaccination services and how the characteristics changed between 2009 and 2015., Methods: The study used a retrospective, cross-sectional design with data from the 2009 and 2015 Medicare Current Beneficiary Survey. Older adults aged 65 and older who completed a community questionnaire and received the influenza vaccination during the previous winter were identified. Andersen's Behavioral Model of Health Services Use was the conceptual framework for inclusion of the population characteristics. A multivariable log-binomial regression was performed to estimate the association between the population characteristics and use of pharmacy-provided vaccination service, and the relative change in associations between 2009 and 2015. Survey weights were applied in all analyses., Results: The results showed older adults who were non-Hispanic black (compared to non-Hispanic white), who did not have secondary private insurance (compared to those who had), who did not have physician office visit (compared to those who had) and who lived in non-metro area (compared to those who lived in metro area) had become more likely to use pharmacy-provided influenza vaccination services in 2015 than in 2009., Conclusions: Pharmacy-provided influenza vaccination services appear to reduce access barriers for racially and socioeconomically disadvantaged older adults. Findings could help inform not only the retail pharmacies that provide vaccination services to better outreach to potential target populations but also policy makers about the disadvantaged populations that would benefit from the vaccination services provided by retail pharmacies., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Hayney is a consultant for GSK Vaccines and Seqirus and has received research support from Takeda Pharmaceuticals, Dynavax, and Sanofi. Other authors declare no conflict of interest., (© 2023 The Authors.)

Background: Patients with inflammatory bowel disease (IBD) are at an increased risk of infections, including vaccine-preventable diseases (VPDs). The aim of this study was to explore the inpatient prevalence of VPD in patients with IBD, as well as inpatient outcomes., Methods: Retrospective study using the 2013-2017 Nationwide Inpatient Sample databases. All patients 18 years of age or older with International Classification of Diseases, Ninth and 10th Revisions , Clinical Modification (ICD-9/10 CM) codes for IBD were included, as well as patients with VPDs as a principal diagnostic code. The primary outcome was the occurrence and odds of VPD in patients with IBD compared with patients with no IBD. Secondary outcomes were inpatient mortality, morbidity, and economic burden compared with patients with IBD and non-vaccine-preventable infections (VPIs). Multivariate regression yielded adjusted odds ratios., Results: Of 1,622,245 (0.9%) patients with a diagnosis of IBD, 3560 (0.2%) had associated VPDs, while 131,150 patients had non-VPI (8.1%). The most common VPDs were influenza, herpes zoster (HZ), pneumococcal pneumonia, and varicella. Only HZ and varicella had increased odds of occurrence in patients with IBD of all ages. Patients with IBD 65 years of age or older had increased odds of VPD compared with patients under 65 years. Patients with IBD and associated VPD had higher odds of intensive care unit stay, systemic inflammatory response syndrome, and multiorgan failure compared with patients with IBD and non-VPI., Conclusions: VPDs represent a clinically relevant cause of infectious disease-related hospital admissions in patients with IBD. Patients with IBD are at increased risk for hospitalization due to HZ and varicella. Those hospitalized for VPD have higher morbidity compared with patients with IBD and non-VPI. These findings echo the importance of instituting optimal immunization schedules in patients with IBD, particularly in patients 65 years or older., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Rationale & Objective: High-dose influenza vaccine provides better protection against influenza infection in older adults than standard-dose vaccine. We compared vaccine seroresponse among hemodialysis patients over a period of 4 months after administration of high-dose trivalent inactivated (HD-IIV3), standard-dose quadrivalent inactivated (SD-IIV4), or quadrivalent recombinant quadrivalent (RIV4) influenza vaccine., Study Design: Prospective observational study., Setting & Participants: Patients at 4 hemodialysis clinics who received influenza vaccine., Exposure: Type of influenza vaccine., Outcome: Hemagglutination inhibition (HI) titers were measured at baseline and at 1, 2, 3, and 4 months after vaccination. The primary outcome was seroprotection rates at HI titers of at least 1:40 and at least 1:160 (antibody levels providing protection from infection in approximately 50% and 95% of immunocompetent individuals, respectively) at 1, 2, 3, and 4 months after vaccination., Analytical Approach: We calculated geometric mean titer as well as seroprotection and seroconversion rates. Adjusted generalized linear models with additional trend analyses were performed to evaluate the association between vaccine type and outcomes., Results: 254 hemodialysis patients were vaccinated against influenza with HD-IIV3 (n = 141), SD-IIV4 (n = 36), or RIV4 (n = 77). A robust initial seroresponse to influenza A strains was observed after all 3 vaccines. Geometric mean titer and seroprotection (HI titer ≥1:160) rates against influenza A strains were higher and more sustained with HD-IIV3 than SD-IIV4 or RIV4. More than 80% of patients vaccinated with HD-IIV3 were seroprotected (HI titer ≥1:160) at month 4 (P < 0.001), whereas, among patients vaccinated with SD-IIV4 or RIV4, seroprotection rates were similar to those at baseline. Seroprotection rates were lower against B strains for all vaccines., Limitations: Because of the use of observational data, bias from unmeasured confounders may exist. Some age subgroups were small in number. Clinical outcome data were not available., Conclusions: Hemodialysis patients exhibited high seroprotection rates after all 3 influenza vaccines. The seroresponse waned more slowly with HD-IIV3 compared with SD-IIV4 and RIV4 vaccines., (Copyright © 2022 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Patients with chronic liver disease (CLD) and liver transplant recipients are at increased risk for infections from vaccine-preventable diseases. Gastroenterologists and hepatologists should assess patient immunization history, and necessary vaccinations should be given as soon as possible. Vaccines demonstrate superior immunogenicity when given earlier in the course of liver disease and prior to transplant. This article summarizes recommendations from the Advisory Committee on Immunization Practices for vaccinations in patients with CLD and liver transplant recipients, and includes a discussion of the influenza, herpes zoster, hepatitis A, hepatitis B, pneumococcal, human papillomavirus, and COVID-19 vaccines., (Copyright © 2022, Gastro-Hep Communications, Inc.)

Introduction: Patients with inflammatory bowel disease (IBD) are at an increased risk of herpes zoster (HZ). HZ is caused by reactivation of the varicella zoster virus (VZV) and is prevented by strong VZV-specific cell-mediated immunity. The aim of our study was to evaluate whether patients with IBD had lower or equivalent protection compared with healthy controls (HCs) at age 50 years and older., Methods: We performed a cross-sectional study at a single academic center and evaluated cellular and humoral immunity to VZV in patients with IBD at age 35-49 years vs HCs aged 50-59 years. All patients with IBD were on stable medication regimens for at least 3 months. VZV-specific cell-mediated immunity was measured via ELISPOT, and humoral immunity was measured via a quantitative VZV antibody enzyme-linked immunosorbent assay assay., Results: Seventy-seven patients with IBD and 12 HCs were enrolled in the study. There was no significant difference in ELISPOT counts between patients with IBD and HCs (P = 0.54). In addition, there was also no significant difference between ELISPOT counts in immunosuppressed patients with IBD (N = 45) and HCs (P = 0.32). We also found no correlations between ELISPOT counts and age (Spearman rho 0.014; P = 0.90). Patients with IBD had similar IgG VZV antibody levels (median 19 mIU/mL; range 0.5-218) compared with HCs (median 23.5 mIU/mL (range 4-34); P = 0.54)., Discussion: Young patients with IBD have equivalent cellular and humoral immunity to VZV as healthy older adults in whom HZ immunization is recommended., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology.)

Introduction: Patients with inflammatory bowel disease (IBD) on immune-modifying therapies may have a lower vaccine response to certain vaccines. The aim of our study was to evaluate humoral immunogenicity of mRNA coronavirus disease 2019 (COVID-19) vaccines among patients with IBD and healthy controls (HCs)., Methods: We performed a prospective study to evaluate humoral immunogenicity among patients with IBD and HCs after completion of mRNA COVID-19 vaccines., Results: One hundred twenty-two patients with IBD and 60 HCs were enrolled. All HCs and 97% of patients with IBD developed antibodies. Antibody concentrations were lower in patients with IBD compared with those in HCs (median 31 vs 118 μg/mL; P < 0.001). Those who received the mRNA-1273 (Moderna) COVID-19 (median 38; interquartile range [IQR] 24-75 vs μg/mL) had higher antibody concentrations compared with those who received the Pfizer-BNT vaccine series (median 22; IQR 11-42 μg/mL; P < 0.001). Patients on immune-modifying therapy (median 26; IQR 13-50 μg/mL) had lower antibody concentrations compared with those who were on no treatment, aminosalicylates, or vedolizumab (median 59; IQR 31-75 μg/mL; P = 0.003)., Discussion: Almost all patients with IBD in our study mounted an antibody response. Future studies are needed in evaluating sustained humoral immunity and the impact of booster dosing in patients with IBD., (Copyright © 2021 by The American College of Gastroenterology.)

The exposure risk to the highly infectious hepatitis B virus (HBV) is an established and recognizable hazard to healthcare professionals (HCPs). In the United States, implementing preemptive vaccination programs and safety procedures resulted in drastic reductions in HBV infections among HCPs; however, many HCPs remain unprotected and risk of exposure persists, especially among those first entering a healthcare system and undergoing professional training. First-generation HBV vaccines require completion of a 3-dose schedule over a 6-month interval for maximum immunogenicity. By comparison, HepB-CpG (HEPLISAV-B®) is a 2-dose HBV vaccine licensed in the United States in 2017, inducing rapid seroprotection over a 1-month interval and may represent a more effective strategy for combating HBV infection in US healthcare systems. In this modeling study, the health and economic impact of implementing an HBV vaccination strategy with HepB-CpG versus the 3-dose HBV vaccine (Engerix-B®) was evaluated among HCPs newly entering a healthcare system. The model used effective seroprotection rate, a real-world metric accounting for HCP vaccine compliance and seroprotection rates for different dosing regimens and considered current pricing for postexposure prophylaxis treatment. Compared with the 3-dose vaccine, HepB-CpG was anticipated to provide faster, increased protection against HBV infection among newly entered HCPs. In protecting a greater percentage of HCPs, HepB-CpG was also projected to substantially reduce the risk of HBV exposure. Accordingly, an economic analysis showed HepB-CpG vaccination would reduce costs of postexposure prophylaxis treatment compared with the 3-dose vaccine. Overall, HepB-CpG represents an effective therapeutic strategy against HBV infection for US healthcare systems.

The recent emergency use authorization of a third COVID-19 vaccine means that most patients with inflammatory bowel disease (IBD) will soon be eligible to be vaccinated. Gastroenterology clinicians should be prepared to address patients' concerns regarding safety and efficacy of vaccines. They should also strongly recommend that all their patients be vaccinated with a COVID-19 vaccine. Additionally, they should be prepared to educate patients about logistics that will result in successful vaccination completion. All these measures will be crucial to ensure high uptake among their patients with IBD., (© 2021 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aims: Prevention of vaccine-preventable diseases is important in the care of patients with inflammatory bowel disease (IBD). Thus, accurate immunization histories are critical. Many providers rely on patient self-report when assessing immunization status. The primary aim of our study was to determine the accuracy of self-reported influenza vaccination status in a cohort of patients with IBD., Methods: We conducted a prospective study of patients with IBD who answered a vaccination status questionnaire and compared their responses to the Wisconsin Immunization Registry, a state-wide electronic immunization information system. The primary outcome was the sensitivity and specificity of self-reported influenza vaccination status. A secondary outcome evaluated the sensitivity and specificity of pneumococcal vaccination status., Results: A total of 200 patients with IBD were included in the study. Documented immunization rates were 74.5% for influenza vaccinations and 79.9% for pneumococcal vaccinations. Influenza vaccination self-report had a sensitivity of 98.7%, a specificity of 90.2%, a positive predictive value (PPV) of 96.7% and a negative predictive value (NPV) of 95.8%. In comparison, the sensitivity for pneumococcal vaccination was 83.5% with a specificity of 86.2%, PPV of 96.4%, and NPV of 54.3%., Conclusions: Self-reported influenza immunization status is sensitive and specific in patients with IBD. Accuracy for pneumococcal vaccination is slightly lower, but responses were notable for a high PPV. Self-report is an effective way to determine influenza immunization status and provides useful information for receipt of pneumococcal vaccine in patients with IBD., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: The objectives of this study were to (1) assess the trends in older adult influenza vaccination rates and (2) locations at which U.S. older adults received influenza vaccinations for the 2008-2009 to 2017-2018 influenza seasons, and (3) compare the estimates of influenza vaccination rates and locations with the estimates from other sources reported previously., Methods: Data from the 2009 to 2017 Medicare Current Beneficiary Survey (MCBS) were used in this analysis. The weighted sample included an average of approximately 37 million community-dwelling older Medicare beneficiaries who completed questionnaires per year. The estimates for older adult influenza vaccination rates and the locations that they used to receive the influenza vaccination were weighted and reported for the 2008-2009 to 2017-2018 influenza seasons., Results: The self-reported older adult influenza vaccination rates between 2008-09 and 2017-2018 ranged from 69.6% (24.6 million) to 75.0% (31.3 million). Across the study period, the percentage of older adults receiving the influenza vaccination at a physician office and clinic declined by 10.4%. The decline was more than offset by an increase in older adult influenza vaccination receipt at a community pharmacy, which substantially increased from 16.6% (4.1 million) in 2008-2009 to 34.8% (10.9 million) in 2014-2015. When compared with the estimates from other sources, the absolute value of the MCBS estimates corresponds with National Health Interview Survey estimates. The older adult influenza vaccination rate increased slightly between the 2008-2009 and 2017-2018 influenza seasons but is still below the 90% benchmark., Conclusion: Community pharmacies-increasingly important access points for the influenza vaccination for older adults-likely contributed to the growth in the rate of older adults vaccinated with influenza vaccines., (Copyright © 2021 American Pharmacists Association®. All rights reserved.)

Immunocompromised individuals are at high risk of severe illness and complications from influenza infection. For this reason, immunization using inactivated influenza vaccines is recommended for transplant patients, individuals receiving immunosuppressant treatments, and other persons with immunodeficiency. However, these immunocompromised populations are more likely to have lower and non-protective responses to annual vaccination with a standard influenza vaccine. Here, we review strategies aimed to improve the immunogenicity of influenza vaccines in immunocompromised populations. The different strategies employed have included adjuvanted vaccines, high-dose vaccines, booster doses, intradermal vaccination, and temporary discontinuation of immunosuppressant treatment regimens. High-dose trivalent, inactivated, split-virus influenza vaccine (IIV3-HD) is so far one of the leading strategies for improving vaccine responses in HIV patients, transplant patients, and persons receiving immunosuppressant therapies for inflammatory diseases. Several studies in these populations have shown stronger humoral responses with IIV3-HD than existing standard-dose trivalent vaccine, and comparable safety. Accordingly, some scientific societies have stated that high-dose influenza vaccine could be a preferred option for immunocompromised patients. However, larger randomized controlled studies are needed to validate relative immunogenicity and safety of IIV3-HD and other enhanced vaccines and vaccination strategies in immunocompromised individuals., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Recent advances in the treatment of inflammatory bowel disease (IBD) include the use of immune modifiers and monoclonal antibodies, such as tumor necrosis factor (TNF) alpha inhibitors, anti-integrin agents, janus kinase inhibitors, and interleukin-12/23 inhibitors. These agents achieve higher rates of clinical remission and mucosal healing than conventional therapy. However, these therapies increase the risk of infections, including some vaccine-preventable diseases. Infections are one of the most common adverse event of immunosuppressive therapy. Thus, providers should optimize immunization strategies to reduce the risk of vaccine-preventable infections in patients with IBD. There are several newly licensed vaccines recommended for adults by the US Advisory Committee on Immunization Practices. This review will focus on how gastroenterology providers can implement the adult immunization schedule approved by ACIP for patients with IBD., (© 2020 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To assess the association of various immunization- and pharmacy-related factors with the timeliness of pharmacy data entry in a state immunization information system., Design: A cross-sectional study was conducted., Setting and Participants: Data for 2,040,248 immunizations administered by pharmacies in Wisconsin during 2012-2017 were collected from the Wisconsin Immunization Registry (WIR). Variables, including the submission method, immunization administration year, vaccine type, and recipient age, were analyzed through multivariate logistic regression to determine if they had a relationship with data entry timeliness. Pharmacists were surveyed on immunization data entry practices to corroborate analysis findings., Outcome Measures: Timeliness of immunization data entry in WIR was measured as a binary variable: 7 days or fewer or more than 7 days after immunization., Results: Influenza immunizations were statistically significantly less likely to be timely compared with noninfluenza immunizations (odds ratio [OR] 0.719 [95% CI 0.712-0.726]; P < 0.0001). Immunizations administered to individuals aged more than 18 years were less timely compared with immunizations administered to individuals aged 6-18 years. The magnitude showed a slight difference in timeliness but without statistical significance (0.989 [95% CI 0.972-1.006]; P > 0.05). For submission method, flat-file submission was less likely to be timely compared with manual entry (0.48 [95% CI 0.475-0.486]; P < 0.0001). Health Level-7 submission, involving the electronic exchange of information with electronic health systems, was much more likely to be timely compared with manual entry (1.989 [95% CI 1.972-2.007]; P < 0.0001). With each successive year, from 2012 to 2017, immunizations were entered in a less timely manner (0.981 [95% CI 0.979-0.983]; P < 0.0001)., Conclusions: Timeliness of pharmacy data entry in WIR was associated with entry method, vaccine type, and immunization administration year. We hope to identify ways to help pharmacies improve immunization data entry in WIR and facilitate the communication of immunization information among providers., (Copyright © 2019 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Patients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy., Methods: We performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months., Results: Sixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively)., Conclusions: Patients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758)., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Individuals who received the hepatitis B vaccine series as young children are entering the healthcare workforce. Our study measured the persistence of antibody to the hepatitis B surface antigen (anti-HBs) at time of employment. Among 986 individuals born in 1991 or more recently with documentation of completion of the hepatitis B vaccine series, 51% had anti-HBs < 10mIU/ml. Of these 507 healthcare workers, 446 (88%) received documented fourth dose of hepatitis B vaccine followed by another anti-HBs ≥ 28 days post vaccination; 11% (50/446 or 5% of the total population) did not mount an anamnestic response. The non-responders were more likely to be male or complete the vaccine series prior to age 7 months. Measuring anti-HBs at the time of hire in this population of healthcare workers who had documentation of hepatitis B series completion as young children may be unnecessary because of the high rate of hepatitis B vaccine protection., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2019 Elsevier Ltd. All rights reserved.)