Neutralizing antibody immune correlates in COVAIL trial recipients of an mRNA second COVID-19 vaccine boost.

Neutralizing antibody titer has been a surrogate endpoint for guiding COVID-19 vaccine approval and use, although the pandemic's evolution and the introduction of variant-adapted vaccine boosters raise questions as to this surrogate's contemporary performance. For 985 recipients of an mRNA second bivalent or monovalent booster containing various Spike inserts [Prototype (Ancestral), Beta, Delta, and/or Omicron BA.1 or BA.

Evaluation of Intestinal Permeability Using Serum Biomarkers in Learning Early About Peanut Allergy Trial.

Background: Intestinal barrier dysfunction may lead to a break in tolerance and development of food allergy (FA). There is contradictory evidence on whether intestinal permeability (IP) is altered in IgE-mediated FA. Thus, we sought to determine whether IP differed between children with eczema who did (FA group) or did not (atopic controls, ACs) develop FA and whether peanut sensitization, allergy, and early introduction impacted IP using serum biomarkers zonulin, soluble CD14, and Intestinal Fatty Acid Binding Protein among randomly selected participants enrolled in the Learning Early About Peanut allergy trial.

PET/CT guided tuberculosis treatment shortening: a randomized trial.

Six months of chemotherapy using current agents is standard of care for pulmonary, drug-sensitive tuberculosis (TB), even though some are believed to be cured more rapidly and others require longer therapy. Understanding what factors determine the length of treatment required for durable cure in individual patients would allow individualization of treatment durations, provide better clinical tools to determine the of appropriate duration of new regimens, as well as reduce the cost of large Phase III studies to determine the optimal combinations to use in TB control programs. We conducted a randomized clinical trial in South Africa and China that recruited 704 participants with newly diagnosed, drug-sensitive pulmonary tuberculosis and stratified them based on radiographic disease characteristics as assessed by FDG PET/CT scan readers.

Demographics, Epidemiology, Mortality, and Difficult-To-Treat Resistance Patterns of Bacterial Bloodstream Infections in the Global United States Military Health System from 2010-2019: A Retrospective Cohort Study.

Objective: To describe demographics, causative pathogens, hospitalization, mortality, and antimicrobial resistance of bacterial bloodstream infections (BSIs) among beneficiaries in the global U.S. Military Health System (MHS), a single-provider healthcare system with 10-year longitudinal follow-up.

Vector induced humoral responses after rVSVΔG-ZEBOV-GP immunization identify vaccinated individuals and correlate with Ebola virus glycoprotein antibodies.

Background: The robustness and persistence of vaccine antigen-induced antibodies are often used as proxy indicators of vaccine efficacy, but immune responses to vaccine vectors are typically less well-defined. Our study considered the kinetics of immunoglobulin (IgG) responses against the vector (vesicular stomatitis Indiana virus [VSIV]) nucleoprotein (N) and the inserted antigen (Ebola virus [EBOV]) glycoprotein (GP1,2) components of the rVSVΔG-ZEBOV-GP (rVSV-ZEBOV) vaccine and evaluated their use as biomarkers to confirm self-reported vaccination status.

Methods: From the Partnership for Research on Ebola Virus in Liberia (PREVAIL) I clinical trial (NCT02344407), we randomly selected 212 participants who received rVSV-ZEBOV (n=107) or placebo (n=105).

Cardiovascular complications in vascular connective tissue disorders after COVID-19 infection and vaccination.

Background: COVID-19 infection and vaccination have been reported to confer an elevated risk for cardiovascular events (CVE). We sought to determine whether individuals with an underlying vascular connective tissue disorder including Marfan syndrome (MFS), Loeys-Dietz syndrome (LDS), or vascular Ehlers Danlos syndrome (vEDS) are at increased risk for cardiac events after COVID-19 infection or vaccination.

Methods: 325 respondents self-reported data through a cross-sectional, web-based survey available from 22 November 2021, through 15 March 2022 regarding COVID-19 illness and vaccinations, the occurrence of any CVE, and adverse events following vaccination.

Corneal and conjunctival abnormalities in a cohort of survivors from the Western African Ebola virus disease outbreak.

Purpose: To characterize corneal and conjunctival abnormalities (CCAs) and their impact on visual acuity in a cohort of survivors from the Western African Ebola virus disease (EVD) outbreak.

Design: A post hoc analysis of 121 patients, who had previously undergone screening for the Ebola Virus Persistence in Ocular Tissues and Fluids study, was performed.

Methods: Patients underwent a comprehensive ophthalmic exam at the Lowell and Ruth Gess Eye Hospital in Freetown, Sierra Leone.

Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials.

The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglobulin trial used Good Participatory Practices (GPP) to develop materials for study implementation from a global network perspective. GPP guidelines offer a framework for engaging stakeholders throughout the research process.

Long-term visual outcomes and histopathologic findings after cataract surgery in Ebola virus disease survivors in the Ebola virus RNA persistence in ocular tissues and fluids (EVICT) study.

Background/objectives: Ebola virus disease (EVD) survivors develop post-acute ophthalmic sequelae, including a high prevalence of uveitis that may be complicated by vision-threatening cataract. After the non-detection of Ebola virus (EBOV) RNA in sampled ocular fluid, vision impairment due to cataract can be treated safely and effectively via manual small incision cataract surgery (MSICS). However, the long-term ocular visual outcomes and assessment of ocular tissues, including for genomic RNA, have been infrequently or not reported in Western African survivors.

Use of mobile phones to collect data on COVID-19: phone access and participation rates, in Rakai, Uganda.

During the COVID-19 pandemic lockdown, we deployed a rapid, mobile phone-based survey to assess access and participation rates when using mobile phones to collect data on COVID-19 in Rakai, south-central Uganda. We sampled prior Rakai Community Cohort Study (RCCS) participants based on HIV status using mobile phone contacts. We administered a 30-minute phone-based interview to consenting participants to assess their knowledge about different aspects of COVID-19 and their access to care.

Global Health Security in Vision Care: Health Systems Strengthening During Ebola Virus Disease Outbreak Responses.

During the last decade, global health security has been threatened by major Ebola virus disease outbreaks in Western Africa (2014 to 2016) and in eastern Democratic Republic of the Congo (2018 to 2020). Particularly in Western Africa, the outbreak initially overwhelmed health care capacity in already fragile health systems. Thousands of survivors were at risk of newly recognized postacute ocular complications, and their need for urgent ophthalmic care challenged national vision health systems with scarce eye care services.

Establishing Vitreoretinal Surgery Capacity in Sierra Leone: Challenges and Opportunities to Address Retinal Health Disparities in Resource-limited Settings.

A range of challenges exists regarding vitreoretinal (VR) surgical services in resource-limited settings, including Sierra Leone. As a result, retinal pathologies may contribute to vision loss and blindness. In the wake of the 2013 to 2016 outbreak of Ebola virus disease in West Africa, gaps in ophthalmic care were underscored as survivors were experiencing a constellation of sequelae, including uveitis and VR disease.

Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment.

Background And Objectives: Subarachnoid neurocysticercosis (SANCC) is the most severe form of CNS infection and accounts for the majority of neurocysticercosis-associated mortality. Inflammation is important in the treatment of SANCC because overactivity can lead to serious complications, but excessive suppression may be counterproductive toward parasite eradication. A relative abundance of CSF IL-10 to IL-12 has been associated with increased treatment duration for patients with SANCC, suggesting that IL-10 plays an important role in this disease process.

Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial.

In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.

Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

Background: Plasmodium falciparum parasitaemia during pregnancy causes maternal, fetal, and infant mortality. Poor pregnancy outcomes are related to blood-stage parasite sequestration and the ensuing inflammatory response in the placenta, which decreases over successive pregnancies. A radiation-attenuated, non-replicating, whole-organism vaccine based on P falciparum sporozoites (PfSPZ Vaccine) has shown efficacy at preventing infection in African adults.

Key factors that influence quality of life in patients with IgE-mediated food allergy vary by age.

Background: While food allergy (FA) can be fatal, the greatest public health impact of FA arguably lies in its detrimental effect on quality of life (FAQOL). Understanding the factors that contribute to FAQOL at different ages is essential to develop personalized interventions that will improve FAQOL.

Objective: To determine the most influential factors that impact FAQOL across ages in well-phenotyped participants with confirmed FA.

Prospective cohort study of patient demographics, viral agents, seasonality, and outcomes of influenza-like illness in Mexico in the late H1N1-pandemic and post-pandemic years (2010-2014).

Objectives: Influenza-like illness (ILI) caused by respiratory viruses results in various respiratory clinical manifestations. The ILI002 prospective observational cohort study aimed to describe viral agents, seasonality, and outcomes of patients with ILI during four seasons in the influenza H1N1-pandemic and post-pandemic years (2010-2014).

Methods: Patients from six Mexican hospitals were enrolled from April 2010 to March 2014.