MHMary S. Hayney

Mary S. Hayney

*This is an algorithmically generated author record based on publicly available information.

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Mary S. Hayney has a total of 124 co-authors. Here are the top co-authors by number of shared publications:


Latest Publications

  • Safety of Live Vaccine Administration in Patients with Inflammatory Bowel Disease on Immune-Modifying Therapy

    by Freddy Caldera, Mary S. Hayney, Xian Zhang, Michael D. Kappelman, Erica J. Brenner

    Was not provided for this article.

  • High Rates of Seroprotection for Measles in Pediatric Patients With Inflammatory Bowel Disease

    by Freddy Caldera, Mary S. Hayney, Jennifer A. Strople, Arthur J. Kastl, Jeremy Adler, Margie Boccieri, Xian Zhang, Millie D. Long, Michael D. Kappelman

    INTRODUCTION: The ongoing US measles outbreak raises concerns for immunosuppressed children with inflammatory bowel disease (IBD). METHODS: We evaluated measles seroprotection in pediatric patients with IBD using a high-sensitivity ELISA (Zeus) compared with a standard commercial assay. RESULTS: Among 176 patients, 173 (98%) were seropositive despite 87% being on immunosuppressive therapy. In comparison, only 163 (93%) were seropositive by commercial assay, resulting in a negative predictive value of 23%. DISCUSSION: Children with IBD have high measles seroprotection. A negative commercial result should not be interpreted as lack of seroprotection, highlighting the need for more accurate assays.


  • Hepatitis B challenge dose in vaccinated healthcare personnel susceptible at hire

    by Jenna M. Vande Hey, Denita Ward, Ashley Buys, Freddy Caldera, Mary S. Hayney

  • Low Sensitivity of Commercial Assays for Varicella-Zoster Virus Seropositivity in Pediatric Patients With Inflammatory Bowel Disease

    by Freddy Caldera, Mary S. Hayney, Jennifer A. Strople, Arthur J. Kastl, Jeremy Adler, Margie Boccieri, Xian Zhang, Millie D. Long, Michael D. Kappelman

    INTRODUCTION: Pediatric inflammatory bowel disease (IBD) guidelines recommend assessing varicella zoster virus (VZV) immunity before immune suppression. We evaluated the sensitivity of the commercial VZV assay relative to the more sensitive glycoprotein (GP) IgG ELISA. METHODS: We evaluated VZV immunity among 176 children with IBD using both commercial and GP ELISA tests. RESULTS: Using GP ELISA, 90% showed VZV immunity vs 69% on commercial assays. Commercial test sensitivity was 77% with 69% false-negative rate and 32% negative predictive value. DISCUSSION: As commercial VZV assays frequently fail to detect existing immunity in children with IBD, vaccination history should be used to assess VZV immunity.


  • Open Access

    Immunogenicity and Safety of Recombinant Herpes Zoster Vaccine in Patients With Inflammatory Bowel Disease on Vedolizumab or Anti-Tumor Necrosis Factor Therapy

    by Freddy Caldera, Harshitha Mogallapalli, Abdul-Rahman Abusalim, Francis A. Farraye, Mary S. Hayney

    INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster and should receive the recombinant herpes zoster vaccine (RZV). We sought to assess the immunogenicity and safety of RZV series in patients receiving anti-tumor necrosis factor (TNF) therapy compared with those receiving vedolizumab. METHODS: This single-center prospective study enrolled patients with IBD on vedolizumab or anti-TNF monotherapy receiving RZV. Primary outcome assessed cell-mediated immunity (CMI) differences between groups postvaccination. Secondary outcomes included humoral response, sustained immunity, and safety monitoring for adverse events and IBD flares. Assessments occurred at baseline, 30, 240, and 425 days postvaccination. Statistical analyses included nonparametric Mann-Whitney U tests for between-group comparisons and Wilcoxon signed-rank tests for within-group changes, with significance set at P < 0.05. RESULTS: Thirty-three patients enrolled (16 vedolizumab, 17 anti-TNF). CMI responses increased postvaccination in both groups (median 56 cells/million [interquartile range {IQR} 21–102] vs 33 cells/million [IQR 11–73]; P = 0.13), with no significant difference between treatment groups. Both groups showed strong antibody responses to vaccination (preimmunization median: 349.9 mIU/mL [IQR 276.8–402.5] vs 90-day median: 605.0 mIU/mL [IQR 525.6–641.0]; P < 0.001). CMI responses remained elevated at both day 240 and 425 assessments. Antibody levels remained elevated through day 425 (549.1 mIU/mL, IQR 516.1–585.6), substantially higher than prevaccination levels. No IBD flares occurred; most adverse events were mild and transient. DISCUSSION: RZV demonstrated robust immunogenicity and favorable safety profile in patients with IBD receiving either vedolizumab or anti-TNF therapy. Both cellular and humoral immune responses persisted through 425 days postvaccination.


  • Open Access

    Patients With Inflammatory Bowel Disease Are at Increased Risk of Respiratory Syncytial Virus Infections After Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Propensity-Matched Cohort Analysis

    by Saqr Alsakarneh, Oscar Ramirez Ramirez, Mary S. Hayney, Jana G. Hashash, Francis A. Farraye, Freddy Caldera

    INTRODUCTION: Patients with inflammatory bowel disease (IBD) are at an increased risk of infections. Before the COVID-19 pandemic, respiratory syncytial virus (RSV) followed predictable seasonal patterns, which have been recently disrupted. This study aimed to investigate whether severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) infection is associated with an increased risk of RSV infection in patients with IBD compared with those without a history of SARS-CoV-2 infection. METHODS: This retrospective cohort study used the TriNetX database to identify patients aged 18 years and older with IBD and SARS-CoV-2 infection (IBD-SARS-CoV-2 cohort) during the 2022 and 2023 RSV seasons. A 1:1 propensity score matching was used to compare patients with IBD but no history of SARS-CoV-2 infection (IBD non-SARS-CoV-2 cohort). RESULTS: In the 2022 IBD-SARS-CoV-2 cohort (mean age: 53.7 ± 17.6 years; 59% female; 77% White), the RSV infection risk was 0.47%, higher than 0.19% in the matched IBD non-SARS-CoV-2 cohort (adjusted odds ratio [aOR]: 2.4; 95% CI: 1.5–3.6). The risk was highest 30–60 days after SARS-CoV-2 infection (aOR: 2.9; 95% CI: 1.7–4.9), particularly in those aged 60 years and older (aOR: 2.5; 95% CI: 1.3–4.5). The use of systemic corticosteroids (aOR: 2.3; 95% CI: 1.1–4.6) or immune-modifying therapies (aOR: 3.9; 95% CI: 2–7.1) was associated with higher RSV infection risk. Similar trends were observed during the 2023 RSV season, with no significant differences in RSV-related hospitalizations. DISCUSSION: Adults with IBD have a higher risk of RSV infection after SARS-CoV-2 infection, particularly those receiving steroids or immune therapies. SARS-CoV-2 infection may have contributed to the recent RSV infection surge in this population, warranting further research.


  • Low Incidence of Varicella in Pediatric Patients With Inflammatory Bowel Disease

    by Freddy Caldera, Mary S. Hayney, Francis A. Farraye, Monika Fischer, Huiping Xu, Michael D. Kappelman

    INTRODUCTION: Immune-modifying therapies in pediatric inflammatory bowel disease (IBD) increase infection risks, including varicella. METHODS: Using Optum's deidentified Clinformatics Data Mart Database, a nationwide US commercial insurance claims database (2007–2022), we conducted a retrospective study of 5,368 patients with IBD aged 21 years or younger matched to a non-IBD cohort. The primary outcome was incidence of varicella. RESULTS: Varicella incidence was low in both groups (IBD: 0.570 vs non-IBD: 0.297 per 1,000 person-years, P = 0.23). At year 4, cumulative varicella incidence was 0.27% for IBD and 0.18% for non-IBD (P = 0.24). No hospitalizations or deaths occurred. DISCUSSION: Despite immune-modifying therapy, pediatric patients with IBD demonstrate low varicella incidence.


  • Open Access

    High Rate of Seroprotection With Heplisav-B in Patients With Inflammatory Bowel Disease

    by Yash Hegde, Sarah K. Lazarus, Francis A. Md Farraye, Fauzia Hollnagel, Mary S. Hayney, Freddy Do Caldera

    Objective: Patients with inflammatory bowel disease (IBD) are commonly treated with immunosuppressive therapies that increase the risk for infections, including hepatitis B (HepB) virus. Adult patients with IBD have suboptimal seroprotection rates after vaccination with a 3-dose recombinant recombinant HepB vaccine. Heplisav-B is an adjuvanted 2-dose HepB series that is more immunogenic in the general adult population. Herein, we evaluated the immunogenicity of Heplisav-B in adult patients with IBD. Patients and Methods: We conducted a prospective observational study of adult patients with IBD who were not seroprotected to HepB virus and received a Heplisav-B series with postimmunization HepB surface antibody (anti-HBs) serologic testing. Postimmunization anti-HBs ≥10 IU/mL was considered seroprotection. The primary outcome was the rate of seroprotection. Secondary outcomes were rates of seroprotection in different age groups, those on immunosuppressive therapy, and previous HepB vaccine nonresponders using a univariate analysis. Results: Eighty-five patients met the inclusion criteria with the majority (72%) achieving seroprotection with a median anti-HBs level of 48.7 IU/mL and 28 patients (33%) having an anti-HBs level >100 IU/mL. Those on immunosuppressive therapy [49 (58%), 18 nonresponders, odds ratio: 0.34, 95% CI: 0.12-0.99] and primary nonresponders to a previous HepB series [22 (26%), 11 nonresponders, odds ratio: 0.26, 95% CI: 0.09-0.73] were less likely to achieve seroprotection. Seven patients who did not respond received a third dose of Heplisav-B, and 2 achieved seroprotection. Conclusions: Heplisav-B achieved higher rates of seroprotection than those seen with 3-dose recombinant HepB vaccines in patients with IBD and may be the preferred option.


  • Open Access

    Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab

    by Yash Hegde, Mary S. Hayney, Freddy Caldera

    Patients with inflammatory bowel disease who receive immunosuppressive therapy have an increased risk of infection. Live vaccines are contraindicated in these patients because of the increased risk of unchecked replication of the attenuated vaccine microorganisms. Vedolizumab is a gut-selective biological agent with a low risk of infection approved for the treatment of inflammatory bowel disease. There are limited data on the risk of providing a live vaccine in patients receiving vedolizumab, and patients may receive live vaccines if the benefits outweigh the risks. We describe a patient with ulcerative colitis, treated with vedolizumab who received 2 live vaccines, typhoid and yellow fever, without postimmunization adverse events.


  • Hepatitis B–CpG Vaccine Series for Healthcare Workers Who Are Hepatitis B Vaccine Nonresponders

    by Rachel K Russ, Haley M Vandehei, Maria I Golovkina, Harshitha Mogallapalli, Freddy Caldera, Mary S Hayney

    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.