Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials.

Background: Malaria remains a substantial public health burden among young children in sub-Saharan Africa and a highly efficacious vaccine eliciting a durable immune response would be a useful tool for controlling malaria. R21 is a malaria vaccine comprising nanoparticles, formed from a circumsporozoite protein and hepatitis B surface antigen (HBsAg) fusion protein, without any unfused HBsAg, and is administered with the saponin-based Matrix-M adjuvant. This study aimed to assess the safety and immunogenicity of the malaria vaccine candidate, R21, administered with or without adjuvant Matrix-M in adults naïve to malaria infection and in healthy adults from malaria endemic areas.

Predictive Validity of the Academy of Nutrition and Dietetics/American Society for Parental Nutrition Indicators to Diagnose Malnutrition and the Screening Tool for Risk on Nutritional Status and Growth among Hospitalized Children Relative to Medical Outcomes.

Objective: To evaluate predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Indicators to diagnose pediatric malnutrition (AAIMp) and the Screening Tool for Risk on Nutritional Status and Growth (STRONGkids) in regard to pediatric patient outcomes in US hospitals.

Study Design: A prospective cohort study (Clinical Trial Registry: NCT03928548) was completed from August 2019 through January 2023 with 27 pediatric hospitals or units from 18 US states and Washington DC.

Results: Three hundred and forty-five children were enrolled in the cohort (n = 188 in the AAIMp validation subgroup).

A pseudotyped adenovirus serotype 5 vector with serotype 49 fiber knob is an effective vector for vaccine and gene therapy applications.

Adenoviruses (Ads) have demonstrated significant success as replication-deficient (RD) viral vectored vaccines, as well as broad potential across gene therapy and cancer therapy. Ad vectors transduce human cells via direct interactions between the viral fiber knob and cell surface receptors, with secondary cellular integrin interactions. Ad receptor usage is diverse across the extensive phylogeny.

Gender-Sexuality Alliance Experiences and LGBTQ+ Inclusive School Policies and Practices Predict Youth's School Belonging.

Gender-Sexuality Alliances (GSAs) and inclusive school policies and practices that affirm youth with minoritized sexual orientations or gender identities (e.g., lesbian, gay, bisexual, transgender, queer youth; LGBTQ+ youth) are two sources of support for LGBTQ+ youth that could promote school belonging.

The Immune System-A Double-Edged Sword for Adenovirus-Based Therapies.

Pathogenic adenovirus (Ad) infections are widespread but typically mild and transient, except in the immunocompromised. As vectors for gene therapy, vaccine, and oncology applications, Ad-based platforms offer advantages, including ease of genetic manipulation, scale of production, and well-established safety profiles, making them attractive tools for therapeutic development. However, the immune system often poses a significant challenge that must be overcome for adenovirus-based therapies to be truly efficacious.

A chimeric haemagglutinin-based universal influenza virus vaccine boosts human cellular immune responses directed towards the conserved haemagglutinin stalk domain and the viral nucleoprotein.

Background: The development of a universal influenza virus vaccine, to protect against both seasonal and pandemic influenza A viruses, is a long-standing public health goal. The conserved stalk domain of haemagglutinin (HA) is a promising vaccine target. However, the stalk is immunosubdominant.

in domestic doe goats in the United States, 2019-2020.

is a bacterial pathogen capable of causing serious disease in humans and abortions in goats. Infected goats can shed . through urine, feces, and parturient byproducts, which can lead to infections in humans when the bacteria are inhaled.

Health Insurance Navigation Tools Intervention: A Pilot Trial Within the Childhood Cancer Survivor Study.

Purpose: Childhood cancer survivors are at increased risk for underinsurance and health insurance-related financial burden. Interventions targeting health insurance literacy (HIL) to improve the ability to understand and use health insurance are needed.

Methods: We codeveloped a four-session health insurance navigation tools (HINT) intervention, delivered synchronously by a patient navigator, and a corresponding booklet.

Predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators to diagnose malnutrition tool in hospitalized adults: a cohort study.

Background: The lack of a widely accepted, broadly validated tool for diagnosing malnutrition in hospitalized patients limits the ability to assess the integral role of nutrition as an input and outcome of health, disease, and treatment.

Objectives: This study aimed to evaluate the predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition (ASPEN) indicators to diagnose malnutrition (AAIM) tool and determine if it can be simplified.

Methods: A prospective cohort study was conducted from August 2019 to September 2022 with 32 hospitals in United States.

Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease.

Background And Aims: Ontamalimab is a fully human immunoglobulin G2 monoclonal antibody against mucosal addressin cell adhesion molecule-1, developed as treatment for inflammatory bowel disease.

Methods: Six phase 3, multicentre, randomised, double-blind, placebo-controlled clinical trials compared efficacy and safety of ontamalimab [25 mg and 75 mg once every 4 weeks] with placebo in patients with moderate-to-severe ulcerative colitis or Crohn's disease [two induction studies and one re-randomised maintenance study per condition]. This clinical trial programme was discontinued in 2020 for reasons unrelated to drug safety/efficacy; Crohn's disease studies are described in the Supplementary data.

Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials.

Background: Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy.

Methods: OAKS and DERBY were two 24-month, multicentre, randomised, double-masked, sham-controlled, phase 3 studies, in which patients aged 60 years and older with geographic atrophy secondary to age-related macular degeneration were enrolled at 110 clinical sites and 122 clinical sites worldwide, respectively.

Do cancer curvivors and metavivors have distinct needs for stress management intervention? Retrospective analysis of a mind-body survivorship program.

Purpose: Cancer "curvivors" (completed initial curative intent treatment with surgery, radiation, chemotherapy, and/or other novel therapies) and "metavivors" (living with metastatic or chronic, incurable cancer) experience unique stressors, but it remains unknown whether these differences impact benefits from mind-body interventions. This study explored differences between curvivors and metavivors in distress (depression, anxiety, worry) and resiliency changes over the course of an 8-week group program, based in mind-body stress reduction, cognitive-behavioral therapy (CBT), and positive psychology.

Methods: From 2017-2021, 192 cancer survivors (83% curvivors; 17% metavivors) completed optional online surveys of resiliency (CES) and distress (PHQ-8, GAD-7, PSWQ-3) pre- and post- participation in an established clinical program.

A single-shot adenoviral vaccine provides hemagglutinin stalk-mediated protection against heterosubtypic influenza challenge in mice.

Conventional influenza vaccines fail to confer broad protection against diverse influenza A viruses with pandemic potential. Efforts to develop a universal influenza virus vaccine include refocusing immunity towards the highly conserved stalk domain of the influenza virus surface glycoprotein, hemagglutinin (HA). We constructed a non-replicating adenoviral (Ad) vector, encoding a secreted form of H1 HA, to evaluate HA stalk-focused immunity.

To clot or not to clot? Ad is the question-Insights on mechanisms related to vaccine-induced thrombotic thrombocytopenia.

Vaccine-induced immune thrombotic thrombocytopenia (VITT) has caused global concern. VITT is characterized by thrombosis and thrombocytopenia following COVID-19 vaccinations with the AstraZeneca ChAdOx1 nCov-19 and the Janssen Ad26.COV2.

Incisional Infection Postphacoemulsification in a Chilean Flamingo ().

A 32-year-old captive female Chilean flamingo () was diagnosed with a hypermature resorbed cataract in the right eye and a mature cataract with phacolytic uveitis in the left eye. No other systemic or neurologic physical abnormalities were detected. The patient was considered blind from bilateral cataracts, and with a reduced quality of life, surgery was indicated to remove the mature cataract in the left eye.

Performance characteristics of high-frequency percussive ventilation under hyperbaric conditions.

Introduction: Safe administration of critical care hyperbaric medicine requires specialized equipment and advanced training. Equipment must be tested in order to evaluate function in the hyperbaric environment. High-frequency percussive ventilation (HFPV) has been used in intensive care settings effectively, but it has never been tested in a hyperbaric chamber.

Academy of Nutrition and Dietetics Nutrition Research Network: Rationale and Protocol for a Study to Validate the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition Consensus-Derived Diagnostic Indicators For Adult And Pediatric Malnutrition and to Determine Optimal Registered Dietitian Nutritionist Staffing in Acute Care Hospital Settings.

No systematic, universally accepted method of diagnosing malnutrition in hospitalized patients exists, which may contribute to underdiagnosis, undertreatment, and poorer patient outcomes. To address this issue, the Academy of Nutrition and Dietetics is conducting a cohort study to: assess the predictive validity of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition indicators for the diagnosis of adult and pediatric malnutrition in hospital settings; assess the interrater reliability of the indicators for the diagnosis of adult and pediatric malnutrition; and quantify the level of registered dietitian nutritionist care needed to improve patient outcomes. Up to 60 adult and 60 pediatric hospital sites will collect data to estimate level of registered dietitian nutritionist care, along with patient medical history and Malnutrition Screening Tool (adult) or STRONGkids (pediatric) results.

Adenoviral Vectors as Vaccines for Emerging Avian Influenza Viruses.

It is evident that the emergence of infectious diseases, which have the potential for spillover from animal reservoirs, pose an ongoing threat to global health. Zoonotic transmission events have increased in frequency in recent decades due to changes in human behavior, including increased international travel, the wildlife trade, deforestation, and the intensification of farming practices to meet demand for meat consumption. Influenza A viruses (IAV) possess a number of features which make them a pandemic threat and a major concern for human health.

Long-term Safety and Efficacy of the Anti-MAdCAM-1 Monoclonal Antibody Ontamalimab [SHP647] for the Treatment of Ulcerative Colitis: The Open-label Study TURANDOT II.

Background And Aims: Ontamalimab, a fully-human monoclonal antibody targeting MAdCAM-1, induced remission in patients with moderate-to-severe ulcerative colitis [UC] in the TURANDOT study. We aimed to assess long-term safety, tolerability, and efficacy of ontamalimab in TURANDOT II.

Methods: TURANDOT II was a phase 2, multicentre, open-label [OL] study in patients with moderate-to-severe UC who completed TURANDOT on placebo or ontamalimab (NCT01771809).

Quantification of gastric mucosal microcirculation as a surrogate marker of portal hypertension by spatially resolved subdiffuse reflectance spectroscopy in diagnosis of cirrhosis: a proof-of-concept study.

Background And Aims: Portal pressure can be used to identify patients with chronic liver disease who have progressed to cirrhosis. Portal pressure can also provide accurate prognostication for patients with cirrhosis. However, there are no practical means for assessment of portal pressure.