Digital Commons Network^™

Lay Down And Wait For Good News Unless You Are Bowling Alone: A Comparison Of The Identity Crisis Confronting The Japanese Corporate Warrior And The American Corporate Law Firm Associate, Mi Kim

University of Miami International and Comparative Law Review

No abstract provided.

In-Hospital Mortality Patterns And Readmissions In Patients With Chronic Obstructive Pulmonary Disease: An Analysis Of The Role Of Pulmonary Hypertension, Saad Afzal Khan, Trishna Parikh, Adishwar Rao, Akriti Agrawal, Aarohi Parikh, Farah Kazzaz, Sarah Shin, Harry Karmouty-Quintana, Maulin Patel, Kha Dinh, Bela Patel, Bindu Akkanti

Faculty, Staff and Student Publications

Chronic obstructive pulmonary disease (COPD) may be complicated by pulmonary hypertension (PH). We aimed to understand the impact of PH on in-hospital mortality and quantify the 30-day readmission rate among patients with COPD. For this cross-sectional study, we used the Nationwide Readmissions Database from 2017-2020 to identify adults ≥18 years with COPD. Patients were stratified according to PH diagnosis. Baseline characteristics between groups were compared using the Pearson chi-square test and two-sample t-test. Predictors of in-hospital mortality were determined using multivariate logistic regression analysis adjusted for demographics and confounders. The 30-day readmission rate and prevalence of PH subgroups by baseline …

Differences In Infection Prevention And Control Staffing Between Free-Standing And System-Affiliated Hospitals: A National Survey., Lucas Philip, Vittorio Maio, Pamela De Cordova, Elizabeth Monsees, Raegan Davis, Pat Moeller, Andrew Dick, Scott W Keith, Monika Pogorzelska-Maziarz

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Infection prevention and control (IPC) staffing varies across US hospitals, and traditional bed-based benchmarks may no longer reflect contemporary workloads or organizational structures. With most hospitals now system-affiliated, understanding how affiliation influences infection preventionist (IP) staffing is critical for modernizing guidance.

METHODS: A national survey was distributed to US acute care hospitals participating in the National Healthcare Safety Network (NHSN) from August to December 2023, assessing IPC staffing, resource availability, and organizational structure. Hospitals were categorized as free-standing or system-affiliated; differences were assessed with Wilcoxon rank-sum and chi-square tests.

RESULTS: Of 741 responding hospitals, 550 (74%) were system-affiliated and …

Support For Human And Civil Rights In Physical Disability, Mental Illness, And Substance Use Disorder, Jessica Williams, Mia Kouveliotes, Nev Jones, Morgan C Shields

2020-Current year OA Pubs

IMPORTANCE: While there is much research on stigma toward marginalized populations, public perceptions regarding deservingness of basic human and civil rights of these groups have not been examined in a nationwide sample of US adults.

OBJECTIVE: To understand the US public's perceptions regarding deservingness of basic human and contested civil rights for people with severe physical disabilities (SPDs), severe mental illness (SMI), and substance use disorders (SUDs).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was a nationwide US internet-based quota panel survey of US adults (aged ≥18 years) who completed the survey. Responses were collected from January 17 to February …

Burden Of Disease In Us Patients With Skeletal Versus Muscular Or Pain Manifestations Of Hypophosphatasia: An Analysis From The Global Hpp Registry., Priya S. Kishnani, Steven Ing, Julie Hoover-Fong, J Carl Pallais, Angie Voskopoja, Shona Fang, William R Mowrey, Eric Rush, Kathryn Dahir

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Hypophosphatasia (HPP) is a metabolic disorder characterized by deficient alkaline phosphatase (ALP) activity, defective mineralization of bones and teeth, and non-skeletal manifestations. We compared disease burden between patients with skeletal and non-skeletal manifestations.

METHODS: Data from US adults enrolled in the Global HPP Registry through July 2024 were analyzed to compare baseline characteristics, genetic testing results, functional outcomes, and patient-reported outcomes between participants with and without overt skeletal manifestations. Patients who had only dental manifestations were excluded.

RESULTS: Of 283 participants, 234 (82.7%) had skeletal manifestations (79.1% female; 89.3% White; median age 48.7 years) and 49 (17.3%) had only …

Eviscerating The State: An Update, Jean L. Cohen

Emancipations: A Journal of Critical Social Analysis

A year after the publication of her article “Eviscerating the State: The New Oligarchic and Authoritarian Project to Undermine American Constitutional Democracy (Emancipations, Vol.4: Iss.2, July 2025) Jean Cohen looks again at the threats to American constitutional democracy posed by new oligarchic and authoritarian actors in the economy, the state, and society.

Blinatumomab Care Delivery For Pediatric B-Cell Acute Lymphoblastic Leukemia, Daniel Zheng, Katelyn Oranges, Subhash Ramakrishnan, Lingyun Ji, Melissa Beauchemin, Sarah Alexander, Allison Leahy, Kira Bona, Emi Caywood, Sharon Castellino, Sumit Gupta, Douglas Hawkins, Olga Militano, Kathleen Montgomery, Haley Newman, Rachel Rau, Susan Rheingold, Joanna Robles, Michael Roth, David Teachey, Sarah Vargas, Sue Zupanec, Susan Parsons

Department of Pediatrics Faculty Papers

IMPORTANCE: Blinatumomab, a novel immunotherapy administered as a 28-day continuous infusion, has fundamentally shifted the treatment paradigm for pediatric B-cell acute lymphoblastic leukemia (B-ALL) and is now considered a component of standard therapy for the most common childhood cancer. However, the care delivery challenges in transitioning from an experimental agent on a clinical trial to widespread clinical implementation are unknown.

OBJECTIVE: To characterize the clinical landscape of pediatric blinatumomab care-delivery practice and challenges in the US from the perspective of treating centers.

DESIGN, SETTING, AND PARTICIPANTS: This survey study was conducted from February to March 2025 among US member institutions …

Research Priorities For Robust Climate Assessments In The United States, Melissa A. Kenney, Robert E. Kopp, Constantine Samaras, Marina Alberti, Sonia Y. Angell, Jennifer Burney, Richelle L. Winkler, Et Al.

Michigan Tech Publications

Scientific assessments play a critical role in synthesizing evidence to support evidence-based decision-making in many sectors and topics. For climate change, large-scale assessments like the Intergovernmental Panel on Climate Change (IPCC) and the United States (U.S.) National Climate Assessment (NCA) reports help many different users—from national government to local governments, Indigenous Peoples and communities, the private sector, the social sector, and the scientific community itself—navigate the complex field of climate risks, impacts, and integrated solutions. While co-creation with users is essential to developing actionable assessments, this paper lays the groundwork for future processes by identifying many advancing and emerging areas …

Book Reviews, Usawc Press

The US Army War College Quarterly: Parameters

No abstract provided.

Implementation Readiness For National Cancer Survivorship Care Standards, Christiane J. El Khoury, Meera Gupta, Maryem Shirzadi, Heidi Dowst, Martha Mims, Maysa Abu-Khalaf, Hoda Badr

Kimmel Cancer Center Faculty Papers

IMPORTANCE: Cancer survivorship care is a growing public health priority, yet delivery remains variable across health systems. The National Standards for Cancer Survivorship Care provide a framework for high-quality care, but little empirical evidence exists regarding health system readiness to implement these standards in routine practice.

OBJECTIVE: To assess implementation readiness for the National Standards for Cancer Survivorship Care and identify perceived barriers to implementation.

DESIGN, SETTING, AND PARTICIPANTS: This real-time Delphi survey study was conducted from January to March 2025 at a National Cancer Institute-designated comprehensive cancer center. Participants were multidisciplinary experts involved in cancer survivorship care delivery, care …

Summit Report: Nuclear Deterrence In An Uncertain World, Manolis Priniotakis

GNSI Summit Reports

The Global and National Security Institute’s Tampa Summit 6 took place on March 24-25, 2026, and examined a nuclear weapons environment marked by renewed uncertainty, weakened institutions, and rapid strategic change. General (Ret.) Frank McKenzie’s opening keynote framed the central challenge: The nuclear age never ended, but the United States and its allies spent much of the post-Cold War period looking away at other threats while Russia, China, North Korea, and others adapted. The world is now moving from the longstanding and relatively stable “two-body” nuclear order centered on the United States and Russia toward a far more complex “three-body” …

African American Gold Star Mothers: Race, Black Motherhood, Loyalism And European Superiority In The First World War, Giovanni Nickolette Gibbs

Masters Theses, 2020-current

This thesis examines the US government’s pilgrimages for Gold Star Mothers of the First World War. It focuses on the Jim-Crowing of black Gold Star Mothers. Through the analysis of archival records, letters, telegrams, newspaper articles, poems, and secondary literature, the thesis explores how two domineering forces, the National Association for the Advancement of Colored People and the federal government of the United States of America, captured dissension when seeking to send black Gold Star Mothers on segregated pilgrimages to Europe. The War Department’s announcement that the widows’ pilgrimages to Europe in the 1930s would be segregated caused a great …

Conceptual Framework And Key Considerations For Field-Based Infrastructure In Food Is Medicine Research, Shreela V Sharma, Colleen Tewksbury, Christopher R Long, Colleen Spees, Ronit A Ridberg, Reshma Gupta, Erin P Ferranti, Naomi Tice, Eric Peterson, Brian Levine

Faculty, Staff and Student Publications

In 2023, the American Heart Association launched the Healthcare by Food (HCXF) initiative to establish a rigorous evidence base for Food Is Medicine (FIM) programs, so that patients with acute or chronic disease could access FIM programs as a covered benefit under their health insurance. The HCXF initiative is engaging in research, advocacy, and education to support the development and testing of interventions that improve health outcomes. The HCXF initiative launched 9 task forces aligned with research progress, including the Field-Based Infrastructure task force designed to examine broader questions to help support either earlier or later stages of the HCXF …

The Impact Of State Insulin Copayment Caps On Diabetics In The United States, Ryan C. Meyer

All Theses

Insulin is a life-saving medication for people with diabetes that helps regulate blood glucose levels throughout the body. A Type 1 diabetic cannot survive without insulin, and a Type 2 diabetic’s quality of life greatly diminishes without access and use of this drug. Currently, many diabetics skip, ration, or abstain from insulin due to financial barriers. As of June 2026, 29 states have enacted insulin copayment caps for state-regulated commercial health insurance plans to reduce the financial burden of insulin costs. This study examines the impact of these caps on all commercially insured diabetics in the United States, particularly on …

Increased Risk Of Sarcomas In Children With Congenital Anomalies: Findings From The Genetic Overlap Between Anomalies And Cancer In Kids (Goback) Registry Linkage Study, Russ Wolters, Ji Yun Tark, Tiffany M Chambers, Tania A Desrosiers, Michael E Scheurer, Charles Shumate, Wendy N Nembhard, Mahsa M Yazdy, Eirini Nestoridi, Amanda E Janitz, Jean Paul Tanner, Russell S Kirby, Jason L Salemi, Yao Yu, Chad D Huff, Sharon E Plon, Philip J Lupo, Jeremy M Schraw

Faculty, Staff and Students Publications

Background: Pediatric sarcomas are a heterogeneous group of tumors that contribute disproportionately to cancer mortality in children. Although congenital anomalies are among the strongest known risk factors for childhood cancer, the risk of specific sarcoma subtypes among affected individuals has not yet been thoroughly evaluated.

Procedure: We obtained data on maternal and perinatal characteristics, congenital anomalies, and pediatric sarcoma diagnoses for all live births in nine states. We used Cox proportional hazards regression to estimate the hazard ratio (HR) and 95% confidence interval (CI) of sarcoma (overall and by subtype) among children with non-syndromic congenital anomalies. We considered all non-syndromic …

“It’S Not Just Cost”: Barriers To Mammography Screening Access Among Low-Income Women In The United States—A Scoping Review, Julia Messerman, Callia Nickels, Nigel C. James

Health Studies Faculty Publications

Despite the recognized importance of early detection, disparities in mammography access persist among low-income women in the United States. While financial barriers are often emphasized, less is known about how multiple barriers interact to shape access to screening. We conducted a scoping review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines to synthesize evidence on barriers to mammography access among low-income women in the United States. A systematic search of PubMed, CINAHL, and Google Scholar identified peer-reviewed studies published between 2010 and 2025, of which 47 met inclusion criteria. Extracted barriers were categorized into …

Under Pressure: Negative Urgency And Disordered Eating In The Context Of Parental Differential Support, Hamide Gozu, Jenna K. Rieder

College of Humanities and Sciences Faculty Papers

Disordered eating behaviors are prevalent in emerging adulthood and may be shaped by family dynamics. This study examined associations among maternal and paternal differential support, weight-shape concerns, and binge eating and compensatory behaviors in emerging adulthood, while testing the moderating role of negative urgency. Participants were 517 emerging adults from across the United States (ages 18-29; M = 22.60, SD = 3.81; 76% female). Participants reported on parental differential support, weight-shape concerns, eating behaviors, and negative urgency. Using moderated-mediation analyses, we found that weight-shape concerns mediated associations between differential support and eating behaviors. Unequal maternal support and paternal favoritism showed …

Technology Platform (Peer Plus) Supporting The Work Of Peer Recovery Coaches And The Communication Needs Of Individuals In Recovery From Substance Use Disorder: Protocol For An R21 Development And Usability Trial., Amanda Coupe, Jessica Pater, Rachel Pfafman, Victor P Cornet, Elisabeth Andrews, Mindy Flanagan, Dana Albright, Abhinay Balasani, Christopher Becker, Brian Parise, Erik Hess, Tammy Toscos

Health Services and Informatics Research

BACKGROUND: Substance use disorder (SUD) represents a significant public health concern in the United States. SUD recovery is complex and individualized, and support provided by peer recovery coaches (PRCs) can improve outcomes. The PRC-client relationship requires bidirectional mediated communication that is often informal but should be trackable, efficient, and aligned with health care privacy and security regulations. Current workflows and available apps do not meet these needs, illustrating the opportunity for client-centered technology tools. We have developed Peer PLUS (People Leveraging Urgent Support; Parkview Health System, Inc), a HIPAA (Health Insurance Portability and Accountability Act)-compliant mobile app and client management …

Womanhood On The Veranda: Maternalism And The Expansion Of American Women's Public Life, Abigail J. Swanson

History ETDs

Motherhood and child welfare became central organizing principles for reform during the United States Progressive Era.  From these guiding principles, the government formed the United States Children’s Bureau. It was the country's first governmental agency that focused solely on the welfare of children. Mothers writing to the federal government for motherhood advice was a phenomenon that was completely new to twentieth century mothers. Women took pride in their roles as mothers, particularly when it came to child health matters. To the generation of mothers who came before these early twentieth century letter writers, asking the government for advice on child …

Recommendations For Hiv Testing Locations To Reach Youth And Emerging Adults: A Qualitative Study, Henna Budhwani, Gerard Thomas Hogan, Alexis Micheau, Angulique Y. Outlaw, Michael J. Mugavero, Mallory O. Johnson, Robert A. Oster, Lisa B. Hightow-Weidman, Sylvie Naar, Janet M. Turan

International Nursing Research Congress (INRC)

Background: Youth and emerging adults aged 18-29 year are one of the few groups with rising rates of new HIV infections in the United States (US), with those in the southern US being more vulnerable and at elevated risk of acquisition. This is dues to a confluence of factors including but not limited to low HIV testing rates, high levels of stigma, and high rates of poverty in the region. Thus, understanding where and how to reach youth and emerging adults in the under resourced southern US for prevention is essential for advancing the Ending the HIV Epidemic goals.

Methods: …

Using Fecal Diagnostic Tests To Assess The Prevalence Of Fasciola Hepatica In The United States Sheep Population, Brooke A. Delcambre

LSU Master's Theses

Fasciola hepatica, the common liver fluke, is endemic in the Pacific Northwest and Gulf Coast of the United States. To provide updated information on F. hepatica prevalence, as part of the USDA National Animal Health Monitoring System Sheep 2024 study, sheep operations in the top 30 sheep-producing states were identified, and producers were invited to participate. For each operation, feces were collected from at least eight sheep and pooled to form a single composite sample. Two methods were used to identify sheep infected with F. hepatica: fecal sedimentation and indirect sandwich ELISA. At the national level, across 318 operations, 7.1 …

Family Support As A Correlate Of Self-Care In Older Adults With Diabetes In The Us, Solomon Tagbor, Diane E. Berish

International Nursing Research Congress (INRC)

Background: Family support and the maintenance of functional ability are crucial for managing diabetes among older adults (OA). In the United States, diabetes affects 29.2% of OA, and its management is complicated by frailty, polypharmacy, and hospitalizations (Bellary et al., 2021). Supporting individuals’ self-care ability and activities of daily living (ADL) independence can help to support diabetes management. Family support may influence the self-care ability needed for independent diabetes management, but it is less studied. The social-ecological model guided this study (Tudge et al., 2022).

Purpose: To examine the association between family support and self-care ability among OA with diabetes …

Digital Empowerment For South Asian Immigrants: An Intervention For Metabolic Syndrome (Desi-Mets), Amir U. Islam, Sharon Wexler, Lin Drury, Jeffery A. Stahl

International Nursing Research Congress (INRC)

Background: South Asian immigrants (SAIs) in the US have a disproportionately high prevalence of metabolic syndrome (MetS), leading to increased risks of cardiovascular disease and diabetes. Increased waist circumference and early-onset heart disease further potentiate health disparities, underscoring the need for culturally tailored interventions. Digital health interventions (DHIs) have been recognized for their potential to effectively support lifestyle modifications in minority populations, including SAIs, by providing accessible and culturally tailored health management solutions.

Purpose: The purpose of the study is to evaluate the effectiveness of a culturally tailored digital health intervention (CT-mHealth) in reducing MetS among SAIs in Hudson Valley, …

Sexual Orientation And Burnout Among Emergency Medicine Residents, David Rudolph, Kirlos Haroun, Michael Gottlieb, Susan Farrell, Yvette Calderon, Kayla Iuliucci, Lea Moujaes, Blake Denley, P. Logan Weygandt

Department of Emergency Medicine Faculty Papers

IMPORTANCE: Burnout is highly prevalent among emergency medicine (EM) residents and is associated with negative outcomes for physician well-being and patient care. Emerging evidence suggests sexual minority trainees may be at increased risk, but differences within EM residency are not well characterized.

OBJECTIVE: To determine if burnout prevalence among EM residents differs by sexual orientation after adjustment for key confounders.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included US resident physicians who took the 2024 American Board of Emergency Medicine In-Training Exam (ITE) postexamination survey and answered the question on sexual orientation.

EXPOSURE: Sexual minority status (heterosexual or straight and …

Relationship Between Sociodemographic Characteristics At Presentation And Outcomes Of Provoked Venous Thromboembolism In United States Children: A Secondary Analysis Of The Multinational Kids-Duration Of Therapy For Thrombosis Trial., Hope P. Wilson, Maua M. Alleyne, Sanjay Ahuja, Ernest Amankwah, Aisha Bruce, Shannon L. Carpenter, Fernando F. Corrales-Medina, Craig A. Mullen, Arun Panigrahi, Lakshmi Srivaths, Courtney D. Thornburg, Anupam Verma, Gary Woods, Neil A. Goldenberg, Madhvi Rajpurkar

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Venous thromboembolism (VTE) is associated with adverse long-term sequelae, including recurrence and development of chronic venous insufficiency following limb deep vein thrombosis (postthrombotic syndrome [PTS]). Adult VTE studies have demonstrated that lower socioeconomic status, Black race, and Latinx ethnicity are associated with an increased risk of recurrence. Clinical trial-derived pediatric VTE data are limited.

OBJECTIVES: The objective of this study was to assess whether clinical features of provoked VTE and outcomes vary across sociodemographic characteristics and proxies for social determinants of health among children enrolled in the Kids-duration of therapy for thrombosis trial.

METHODS: We conducted a secondary analysis …

Risk Of Fracture Following Androgen Receptor Pathway Inhibitors In Men With Advanced Prostate Cancer, Grace Lu-Yao, Nikita Nikita, Scott W. Keith, Krupa Gandhi, Amy L. Shaver, Swapnil Sharma, Christina Steinbock-Malfer, Hushan Yang, Christopher Yang, Kevin K. Zarrabi, Stephen J. Freedland, William K. Kelly

Kimmel Cancer Center Faculty Papers

BACKGROUND: This population-based study aimed to quantify fracture risk after androgen receptor pathway inhibitors in advanced prostate cancer patients by preexisting health conditions.

METHODS: Patients were identified from the Surveillance, Epidemiology, and End Results-Medicare files who received abiraterone acetate with prednisone or enzalutamide between January 1, 2013, and December 31, 2020. Health and fracture history were based on claims 1 year before androgen receptor pathway inhibitor with follow-up through December 31, 2020. The main outcome of the study was the cumulative fracture risk after first date of androgen receptor pathway inhibitor. Fine and Gray subdistribution hazard model was used to …

Current Practices And Variations Among Pediatric Severe Asthma Programs In The United States-The North American Severe Pediatric Asthma Consortium., Kristina Gaietto, Nadia Krupp, Avani V. Shah, Erhan Ararat, Samantha H. Averill, Sachin Baxi, Matejka Cernelc-Kohan, Jeffrey M. Chambliss, Heather De Keyser, Monica Federico, Bob Geng, Akilah A. Jefferson, Parisa Kaviany, Lila C. Kertz, Kirsten Kloepfer, Allyson Larkin, Sydney Leibel, Tanya Martinez-Fernandez, Samira Naime, Robert D. Pesek, Dinesh K. Pillai, Deepa Rastogi, Katherine Rivera-Spoljaric, Kristie R. Ross, Franziska J. Rosser, Tregony C. Simoneau, Jade Tam-Williams, Kelan G. Tantisira, William Anderson, Jonathan M. Gaffin, Theresa W. Guilbert, Erick Forno

Manuscripts, Articles, Book Chapters and Other Papers

BACKGROUND: Severe and difficult to treat asthma in children is a complex condition causing significant morbidity and associated healthcare costs. While treatment guidelines exist for severe asthma, optimal treatment approaches for the pediatric population are less well established. Furthermore, best practices regarding real world management and implementation of guidelines for the severe pediatric asthma population are lacking. In order to provide care for this population, institutions around the United States have developed multidisciplinary severe pediatric asthma programs (SPAPs). In recent years, the North American Severe Pediatric Asthma Consortium (NASPAC) was established as a mechanism for SPAPs to collaborate and share …

Prescribed Short-Acting Hormonal Contraceptive Use Among Premenopausal Females, Israel Bacha, Suleepon Uttamapinan, Hannah Harsanyi, Abigail Liberty, Lin Yang, Adetunji T Toriola

2020-Current year OA Pubs

IMPORTANCE: Hormonal contraceptive use has important implications for both reproductive and general health. However, the patterns and trends of short-acting hormonal contraceptive use among US premenopausal females remain insufficiently characterized.

OBJECTIVE: To evaluate trends in and factors associated with prescribed short-acting hormonal contraceptive use among US premenopausal females.

DESIGN, SETTING, AND PARTICIPANTS: Serial, cross-sectional analyses were conducted using US nationally representative data from the National Health and Nutrition Examination Survey (NHANES), including 10 survey cycles between 1999 to 2000 and 2017 to 2020 (before the COVID-19 pandemic). Participants included noninstitutionalized premenopausal females aged 15 years to younger than 60 years …

Adlm Guidance Document On Incorporating Gender Diversity In Pathology And Laboratory Medicine, Tiffany A Thomas, Gabrielle N Winston-Mcpherson, Ina Amarillo, Alisha D Berry, Caroline J Davidge-Pitts, Sridevi Devaraj, Zil Goldstein, Brad S Karon, Brooke M Katzman, Mahmoud A Khalifa, Hung S Luu, James H Nichols, Tracy L Stockley, Michelle R Stoffel, Dina N Greene, Matthew D Krasowski

Faculty, Staff and Students Publications

Background: The first international clinical standards of care for the gender-diverse population were formulated in the late 1970s. In the last 15 years, multiple subspecialty societies within the United States have developed clinical care guidelines for those with gender dysphoria, including gender-affirming hormone therapy (GAHT) and surgical treatments. To date, there are no pathology- and laboratory medicine-specific recommendations in the United States for the gender-diverse population.

Content: This document outlines pathology- and laboratory medicine-specific recommendations for providing optimal care to the gender-diverse population, with a predominant focus on the adult population. The scope of this document focuses on the following …

Na-Gst-1 Adsorbed On Alhydrogel Co-Administered With Different Toll-Like Receptor Agonists In Hookworm-Naive Adults Using A Controlled Human Infection Model In The Usa: A Phase 2, Double-Blind, Randomised Controlled Trial, Caroline K Dirosato, Elissa M Malkin, Sean M Lee, Guacyara Erwin, Lara Hoeweler, Larissa Scholte, Maria Elena Bottazzi, David I Pritchard, Peter J Hotez, Jeffrey M Bethony, David J Diemert

Faculty, Staff and Students Publications

Background: Necator americanus glutathione S-transferase-1 (Na-GST-1) performs a crucial enzymatic step in hookworm blood feeding and is a leading target for vaccine development. Phase 1 trials in Brazil, Gabon, and the USA of recombinant Na-GST-1 adsorbed on Alhydrogel (Na-GST-1/Al), co-administered with or without AP 10-701 (Toll-like receptor [TLR] 4 agonist) or CpG 10104 (TLR9 agonist), showed the vaccine was well tolerated, safe, and immunogenic. A controlled human hookworm infection (CHHI) model was previously developed to evaluate the effect of candidate hookworm vaccines on infection. We aimed to assess the effect of vaccination with three different Na-GST-1 vaccine formulations on subsequent …