Efficacy, immunogenicity, and safety of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine.

Background: In this phase 3 trial of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine (RSVPreF3-Mat), a higher rate of preterm birth was observed in the vaccine (6.8%) versus the placebo group (4.9%).

Sensitivity to Environmental Stress and Adversity and Lung Cancer.

Importance: Sensitivity to environmental stress and adversity may influence lung cancer risk, highlighting a critical link between psychosocial factors and cancer etiology.

Objective: To evaluate whether genetically estimated sensitivity to environmental stress and adversity is associated with lung cancer risk.

Design, Setting, And Participants: Data were obtained from a genome-wide association study identifying 37 independent genetic variants strongly associated with sensitivity to environmental stress and adversity and a cross-ancestry genome-wide meta-analysis from the International Lung Cancer Consortium.

Emerging Per- and Polyfluoroalkyl Substances in Tap Water from the American Healthy Homes Survey II.

Humans experience widespread exposure to anthropogenic per- and polyfluoroalkyl substances (PFAS) through various media, which can lead to a wide range of negative health impacts. Tap water is an important source of exposure in communities with any degree of contamination but routine or large-scale PFAS monitoring often depends on targeted analytical methods limited to measuring specific PFAS. We analyzed 680 tap water samples from the American Healthy Homes Survey II for PFAS using non-targeted analysis (NTA) to expand the range of detectable PFAS.

Rapamycin-resistant polyclonal Th1/Tc1 cell therapy (RAPA-201) safely induces disease remissions in relapsed, refractory multiple myeloma.

Background: Polyclonal autologous T cells that are epigenetically reprogrammed through mTOR inhibition and IFN-α polarization (RAPA-201) represent a novel approach to the adoptive T cell therapy of cancer. Ex vivo inhibition of mTOR results causes a shift towards T central memory (T) whereas ex vivo IFN-α promotes type I cytokines, with each of these functions known to enhance the adoptive T cell therapy of cancer. Rapamycin-resistant T cells polarized for a type II cytokine phenotype were previously evaluated in the allogeneic transplantation context.

The 2021 Podiatric Residency Candidate and Program Virtual Interview Experience During COVID-19 with Multispecialty Reflections and Recommendations for a Successful Virtual Match: A 2024 Update.

This objective of this communication is to provide an update from the Council of Teaching Hospitals (COTH) and the American Association of Colleges of Podiatric Medicine (AACPM) with respect to the profession's residency interview process, otherwise known as the Centralized Residency Interview Process (CRIP). During the 2022-2023 academic year, CRIP returned to an in-person format following a period of virtual interviews during the COVID-19 pandemic. Survey data since this change indicate that a large majority of residency program directors and student applicants prefer an in-person format to the residency interview process.

Antiretroviral Use for HIV Prevention During Pregnancy: The Need to Strengthen Regulatory and Surveillance Systems in Africa.

HIV-prevention efforts focusing on women of child-bearing potential are needed to end the HIV epidemic in the African region. The use of antiretroviral drugs as pre-exposure prophylaxis (PrEP) is a critical HIV prevention tool. However, safety data on new antiretrovirals during pregnancy are often limited because pregnant people are excluded from drug development studies.

Challenges to Achieving Surgical Equity in Slums.

There is a critical lack of surgical data on individuals who live in urban slums, which hampers the allocation of healthcare resources and the provision of preventative measures. The complex interplay of factors affecting surgical care in slums, such as trust deficits, mental health concerns, and socioeconomic barriers, necessitates a distinct academic approach. We propose that researchers should consider "slum surgical health" as an area of study separate from urban health or slum health.

ULACNet-301, OPTIMO protocol: optimizing HPV vaccination regimen for cancer prevention in children and adolescents living with HIV.

Background: Persistent infection with human papillomavirus (HPV) is associated with most cervical and anal cancer cases and a large fraction of other anogenital and oropharyngeal cancers. The prophylactic HPV vaccines are known to prevent HPV infections and HPV-associated disease, although there is evidence of reduced response to the HPV vaccination among individuals living with HIV. Prior studies among individuals without HIV suggest that a single HPV vaccine dose induces humoral immune responses that, while lower than those induced by two or three doses, still confer protection against HPV infection.

Syphilis-positive and false-positive trends among US blood donors, 2013-2023.

Background: US blood donors are tested for syphilis because the bacterial agent is transfusion transmissible. Here we describe trends over an 11-year period of donations positive for recent and past syphilis infections, and donations classified as syphilis false positive (FP).

Methods: Data from January 1, 2013, to December 31, 2023 (11 years) were compiled for all American Red Cross blood donations to evaluate demographics/characteristics and longitudinal trends in donors testing syphilis reactive/positive.

Methods to Adjust for Confounding in Test-Negative Design COVID-19 Effectiveness Studies: Simulation Study.

Background: Real-world COVID-19 vaccine effectiveness (VE) studies are investigating exposures of increasing complexity accounting for time since vaccination. These studies require methods that adjust for the confounding that arises when morbidities and demographics are associated with vaccination and the risk of outcome events. Methods based on propensity scores (PS) are well-suited to this when the exposure is dichotomous, but present challenges when the exposure is multinomial.

Menthol cigarette use in US pregnancies: Prevalence, racial/ethnic disparities, and associated characteristics from the 2010-2019 National Survey on Drug Use and Health (NSDUH).

Introduction: Pregnant people who smoke constitute a uniquely vulnerable population likely to be impacted by a menthol cigarette (MC) ban. However, there are no published reports of prevalence of prenatal MC use in a nationally-representative US sample including racial-ethnic disparities and associated characteristics.

Methods: Participants were 1245 US pregnant people who smoked MC or non-MC (NMC) in the past 30-days from the 2010-2019 National Survey on Drug Use and Health.

Genetic Variants of GBP4: Reduced Risks for Drug-Induced Acute Liver Failure in Non-Finnish European Population.

Background And Aims: Acute liver failure (ALF) is a serious condition, typically in individuals without prior liver disease. Drug-induced ALF (DIALF) constitutes a major portion of ALF cases. Our research aimed to identify potential genetic predispositions to DIALF.

HIV service use among minoritized racial and ethnic transgender and gender non-conforming youth in the U.S South: a qualitative investigation.

Transgender youth are disproportionately affected by HIV, particularly minoritized youth in the US south. To understand HIV service use among transgender youth, we interviewed 25 young racial and ethnic minority clients of four southern community-based HIV service organizations (CBOs), and CBO staff ( = 12), about service access and use. Participants were assigned male at birth and identified as female ( = 8), transgender ( = 11) or gender-fluid or nonbinary ( = 6).

Adolescents' Diabetes Self-Management Regimens and Outcomes During the COVID-19 Pandemic: A Scoping Review.

Adolescents with diabetes mellitus (DM) experience poorer glycemic outcomes and lower adherence to self-management regimens compared to other age groups. The coronavirus 2019 (COVID-19) pandemic posed new barriers to DM self-management, including social distancing measures and additional stressors. We conducted a scoping review of peer-reviewed literature to examine self-management regimens and outcomes among adolescents aged 10-17 years with type 1 and type 2 DM during the pandemic.

Not-so-normal hearing: Temporary hearing changes lead to chronic difficulties for listeners with "normal" audiometric thresholds.

Hearing loss has historically been mainly associated with elevated pure-tone thresholds. However, in recent years, there has been increased interest in addressing the hearing difficulties reported by individuals with normal hearing thresholds. In this study, we measured hearing thresholds, noise history, temporary threshold shift history, and hearing difficulty for a sample of 10,492 Service Members.

Protocol for a systematic review and individual participant data meta-analysis for risk factors for lung cancer in individuals with lung nodules identified by low-dose CT screening.

Background: Worldwide, lung cancer (LC) is the second most frequent cancer and the leading cause of cancer related mortality. Low-dose CT (LDCT) screening reduced LC mortality by 20-24% in randomised trials of high-risk populations. A significant proportion of those screened have nodules detected that are found to be benign.

MetAssimulo 2.0: a web app for simulating realistic 1D & 2D Metabolomic 1H NMR spectra.

Unlabelled: Metabolomics extensively utilizes Nuclear Magnetic Resonance (NMR) spectroscopy due to its excellent reproducibility and high throughput. Both one-dimensional (1D) and two-dimensional (2D) NMR spectra provide crucial information for metabolite annotation and quantification, yet present complex overlapping patterns which may require sophisticated machine learning algorithms to decipher. Unfortunately, the limited availability of labeled spectra can hamper application of machine learning, especially deep learning algorithms which require large amounts of labelled data.

2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Global Transcriptomic Analysis of Inbred Lines Reveal Candidate Genes for Response to Maize Lethal Necrosis.

Maize lethal necrosis (MLN) is a significant threat to food security in Sub-Saharan Africa (SSA), with limited commercial inbred lines displaying tolerance. This study analyzed the transcriptomes of four commercially used maize inbred lines and a non-adapted inbred line, all with varying response levels to MLN. RNA-Seq revealed differentially expressed genes in response to infection by maize chlorotic mottle virus (MCMV) and sugarcane mosaic virus (SCMV), the causative agents of MLN.

On the Biosynthesis of Bioactive Tryptamines in Black Cohosh ( L.).

Botanical dietary supplements are widely used, but issues of authenticity, consistency, safety, and efficacy that complicate their poorly understood mechanism of action have prompted questions and concerns in the popular and scientific literature. Black cohosh ( L., syn.

Harnessing the AI/ML in Drug and Biological Products Discovery and Development: The Regulatory Perspective.

Artificial Intelligence (AI) has the disruptive potential to transform patients' lives via innovations in pharmaceutical sciences, drug development, clinical trials, and manufacturing. However, it presents significant challenges, ethical concerns, and risks across sectors and societies. AI's rapid advancement has revealed regulatory gaps as existing public policies struggle to keep pace with the challenges posed by these emerging technologies.

A Method to Evaluate Orientation-Dependent Errors in the Center of Contrast Targets Used with Terrestrial Laser Scanners.

Terrestrial laser scanners (TLS) are portable dimensional measurement instruments used to obtain 3D point clouds of objects in a scene. While TLSs do not require the use of cooperative targets, they are sometimes placed in a scene to fuse or compare data from different instruments or data from the same instrument but from different positions. A contrast target is an example of such a target; it consists of alternating black/white squares that can be printed using a laser printer.