NATIONAL INSTITUTES OF HEALTH

Mpox, caused by monkeypox virus (MPXV), re-emerged in 2024 with clade I strains spreading faster and being deadlier. A new study led by researchers from the United States Army Medical Research Institute of Infectious Diseases, the National Institutes of Health, Boston University, and Moderna, published in *Cell*, demonstrated that mRNA-based vaccines, like mRNA-1769, could be more effective than the modified vaccinia Ankara (MVA) vaccine in protecting against severe mpox disease in macaques. The mRNA-1769 vaccine, targeting four MPXV antigens, showed tenfold fewer lesions and reduced viral load compared to MVA, highlighting the potential of mRNA technology to combat MPXV-like viruses.

Interviews with 11 AI clinical trial investigators reveal current NIH ethical principles are applicable but highlight unique challenges in social value, scientific validity, fair participant selection, risk-benefit ratio, and consent processes. These insights suggest the need for tailored ethical guidance for AI clinical trials.

Opioid overdoses in Texas surged, with Austin-Travis County EMS responding to 75 cases in days, including 50 in 24 hours. A fentanyl vaccine, under development by University of Houston researchers, aims to prevent addiction by blocking the drug from reaching the brain. Clinical trials are set to begin in 2025, though FDA approval and public availability could take 5-10 years. Free Narcan kits are available in Austin to combat overdoses.

Microplastics and nanoplastics (MNPs) are accumulating in human organs, with higher concentrations in brain tissue. Studies suggest potential links to Alzheimer’s, colorectal cancer, and infertility, but clear evidence is lacking. Researchers are exploring routes of exposure and health risks, with clinical laboratories potentially developing tests for MNP levels.

Rafael Dal-Ré and colleagues discuss challenges of new US regulations requiring sharing of individual participant data from federally funded trials, particularly affecting low and middle income countries.

A study in *Nature Communications* reveals insights into how damaged cells interact in disease-promoting microenvironments following acute kidney injury (AKI), potentially aiding in preventing chronic kidney disease (CKD). Researchers used seqFISH technology to analyze gene expression in AKI-affected mouse kidneys, identifying microenvironments like ME-5 and ME-16, which involve cellular interactions linked to CKD progression. A comprehensive map of AKI-induced changes is available at [https://woldlab.caltech.edu/ci2-celltiles/Mouse-Kidney-Fibrosis/](https://woldlab.caltech.edu/ci2-celltiles/Mouse-Kidney-Fibrosis/).

Scientists at Huntsman Cancer Institute developed a new mechanism using PDX models to predict TNBC aggressiveness, potentially revolutionizing treatment by identifying higher-risk patients and tailoring precise treatments. This method is more accurate than existing ones in forecasting TNBC recurrence, offering hope for more personalized and effective treatment strategies.

The National Cancer Institute (NCI) invites applications for support of investigator-initiated studies addressing mechanisms by which bariatric surgery impacts cancer risk. The funding opportunity, titled 'Mechanisms that Impact Cancer Risk after Bariatric Surgery (R01 Clinical Trial Optional)', is open to various organizations and aims to draw in talented scientists to investigate the effects of bariatric surgery on cancer, rather than shorter-term outcomes. The application process includes submitting a letter of intent 30 days prior to the application due date and following the instructions in the Research (R) Instructions in the How to Apply - Application Guide. The funding opportunity number is PAR-25-043, with a budget limited to $500,000 direct costs per year and a maximum project period of 5 years.

U.S. reps ask FDA about biopharmaceutical companies' clinical trials with PLA entities; NSF OIG finds ISU inappropriately charged $9,709 on six awards; UMB's Eckert agrees to 8-year debarment for research misconduct; NIH bans AI use in peer reviews; OHRP finds Emory IRB members may lack clear understanding of approval conditions; NSF updates guidance on reporting multiyear foreign gifts or contracts.