Favorable Nonclinical Safety Profile of RSVpreF Bivalent Vaccine in Rats and Rabbits.

: Respiratory syncytial virus (RSV) infections usually cause mild, cold-like symptoms in most people, but are a leading infectious disease causing infant death and hospitalization and can result in increased morbidity and mortality in older adults and at-risk individuals. Pfizer has developed Abrysvo, an unadjuvanted bivalent recombinant protein subunit vaccine containing prefusion-stabilized fusion (F) proteins representing RSV A and RSV B subgroups (RSVpreF). It is the only RSV vaccine approved for both maternal immunization to protect infants and active immunization of older adults (≥60 years) and 18-59-year-old individuals with high-risk conditions for prevention of RSV disease.

Photothrombolytics: A light-driven technology for the targeted lysis of thrombi.

Occlusive blood clots remain a significant global health challenge and result in emergencies that are main causes of death and disability worldwide. Thrombolytic agents (including tissue plasminogen activator, tPA) are the only pharmacological means to dissolve blood clots. However, these drugs have modest efficacy and severe safety concerns persist.

Session 4: mRNA and Self-Amplifying RNA (saRNA): Opportunities for Disease Prevention and Therapy.

The unprecedented speed of developing vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the COVID-19 pandemic, has propelled mRNA technologies into the public eye. The versatility of mRNA technology, often referred to as "plug and play," offers immense promise for rapidly updating vaccines to address newer variants of respiratory diseases and combat emerging infectious diseases and lethal pathogens, such as the Ebolavirus. However, the potential applications of mRNA technology extend well beyond prophylactic vaccines.

Examining the mental health trajectories of children and adolescents: a cross-cohort analysis.

Background: Epidemiological samples provide opportunity to understand the development of mental health trajectories to better understand whether such epidemiological data can help to plan and modify service delivery for youth mental health. Variation between countries is not well understood and thus applying evidence from other countries to national strategies limits support service policy and planning. We therefore examine developmental patterns of youth mental health across different countries using the Growing Up in Ireland (GUI) Cohorts, with comparison to existing UK longitudinal cohort data (Millennium Cohort Study, MCS; Growing up in Scotland, GUS).

An isochoric optical platform for interrogation of aqueous glass formation processes.

Aqueous vitrification (glass formation) processes are integral to modern cryopreservation, but experimental methods by which to study them are limited, particularly at the mL volume scales relevant to many biomedical applications. Here, we introduce an inexpensive custom optical platform, the isochoric vitrification cryo-macroscope (or "isovitriscope"), to supplement standard techniques with new qualitative and quantitative data streams. The platform consists of an LED light source, a isochoric (constant-volume) chamber with sapphire optical windows, and a camera, which can operate in two modes.

Quadriceps-Strength-Testing Practices and Barriers During Return to Sport After ACL Reconstruction: A Survey of College Athletic Trainers.

Context: Quadriceps strength is a key outcome for guiding rehabilitation and return to sport-specific activities after anterior cruciate ligament reconstruction (ACLR) surgery.

Objective: (1) Describe the quadriceps-strength-testing practices and barriers college athletic trainers (ATs) are using and experiencing when returning patients to sport-specific activities after ACLR. (2) Compare testing methods between college ATs working in the National Collegiate Athletic Association (NCAA) Division I setting and other college settings.

Next-Generation Contraceptive Intravaginal Ring: Comparison of Etonogestrel and Ethinyl Estradiol In Vitro and In Vivo Release from 3D-Printed Intravaginal Ring and NuvaRing.

Intravaginal rings (IVRs) represent a well-established, woman-controlled and sustained vaginal drug delivery system suitable for a wide range of applications. Here, we sought to investigate the differences in etonogestrel (ENG) and ethinyl estradiol (EE) release from a 3D-printed IVR utilizing continuous liquid interface production (CLIP™) (referred to as CLIP for low drug loading and CLIP IVRs for high drug loading) and NuvaRing, a commercially available injection molded IVR. We conducted in vitro release studies in simulated vaginal fluid to compare the release of ENG and EE from CLIP IVRs and NuvaRing.

Instantly adhesive and ultra-elastic patches for dynamic organ and wound repair.

Bioadhesive materials and patches are promising alternatives to surgical sutures and staples. However, many existing bioadhesives do not meet the functional requirements of current surgical procedures and interventions. Here, we present a translational patch material that exhibits instant adhesion to tissues (2.

Implementation of a Clinical Vessel Wall MR Imaging Program at an Academic Medical Center.

Background And Purpose: The slow adoption of new advanced imaging techniques into clinical practice has been a long-standing challenge. Principles of implementation science and the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework were used to build a clinical vessel wall imaging program at an academic medical center.

Materials And Methods: Six phases for implementing a clinical vessel wall MR imaging program were contextualized to the RE-AIM framework.

The role of fathers in child development from preconception to postnatal influences: Opportunities for the National Institutes of Health Environmental influences on Child Health Outcomes (ECHO) program.

A growing body of literature highlights the important role of paternal health and socioemotional characteristics in child development, from preconception through adolescence. Much of this research addresses the indirect effects of fathers, for instance, their influence on maternal behaviors during the prenatal period or via the relationship with their partner. However, emerging evidence also recognizes the direct role of paternal health and behavior for child health and adjustment across development.

NRF2 Activation in Trp53;p16-deficient Mice Drives Oral Squamous Cell Carcinoma.

Unlabelled: Aberrant activation of the NRF2/NFE2L2 transcription factor commonly occurs in head and neck squamous cell carcinomas (HNSCC). Mouse model studies have shown that NRF2 activation alone does not result in cancer. When combined with classic oncogenes and at the right dose, NRF2 activation promotes tumor initiation and progression.

Next generation 3D-printed intravaginal ring for prevention of HIV and unintended pregnancy.

Globally, there are 20 million adolescent girls and young women living with HIV who have limited access to long-acting, effective, women-controlled preventative methods. Additionally, although there are many contraceptive methods available, globally, half of all pregnancies remain unintended. Here we report the first 3D-printed multipurpose prevention technology (MPT) intravaginal ring (IVR) for HIV prevention and contraception.

Spectroscopic insight on impact of environment on natural photoprotectants.

Biomimicry has become a key player in researching new materials for a whole range of applications. In this study, we have taken a crude extract from the red algae containing mycosporine-like amino acids - a photoprotective family of molecules. We have applied the crude extract onto a surface to assess if photoprotection, and more broadly, light-to-heat conversion, is retained; we found it is.

Cross-cohort change in parent-reported emotional problem trajectories across childhood and adolescence in the UK.

Background: Over the past three decades, the prevalence of adolescent emotional problems (ie, anxiety and depression) has risen. Although the onset and developmental course of emotional symptoms shows high variability, no study has directly tested secular differences across development. Our aim was to investigate whether and how developmental trajectories of emotional problems have changed across generations.

Toxicologic Pathology Forum: Tissue Evaluation in Nonclinical Toxicity Studies for Prophylactic Vaccines.

Nonclinical toxicity testing (GLP) of prophylactic vaccines to support human clinical trials is outlined in the World Health Organization nonclinical vaccine-development guidelines, which are followed by most regulatory agencies globally. Vaccine GLP toxicity studies include at least two groups: a buffer control (often phosphate-buffered saline) group and a highest anticipated clinical dose formulation group. However, studies may include additional groups, including lower-dose formulation groups and adjuvant-containing formulation control groups.

Ocular Safety and Toxicokinetics of Bevacizumab-bvzr (Zirabev), a Bevacizumab Biosimilar, Administered to Cynomolgus Monkeys by Intravitreal Injection.

Bevacizumab-bvzr (Zirabev), a recombinant humanized monoclonal antibody targeting vascular endothelial growth factor and a biosimilar to bevacizumab, is approved for intravenous administration for various indications worldwide. The objectives of this study were to evaluate the ocular toxicity, systemic tolerability, and toxicokinetics (TKs) of bevacizumab-bvzr following repeat intravitreal (IVT) injection to cynomolgus monkeys. Male monkeys were administered saline, vehicle, or bevacizumab-bvzr at 1.

Toxicological Assessments of a Pandemic COVID-19 Vaccine-Demonstrating the Suitability of a Platform Approach for mRNA Vaccines.

The emergence of SARS-CoV-2 at the end of 2019 required the swift development of a vaccine to address the pandemic. Nonclinical GLP-compliant studies in Wistar Han rats were initiated to assess the local tolerance, systemic toxicity, and immune response to four mRNA vaccine candidates encoding immunogens derived from the spike (S) glycoprotein of SARS-CoV-2, encapsulated in lipid nanoparticles (LNPs). Vaccine candidates were administered intramuscularly once weekly for three doses at 30 and/or 100 µg followed by a 3-week recovery period.

Using heparan sulfate octadecasaccharide (18-mer) as a multi-target agent to protect against sepsis.

Sepsis is a lethal syndrome manifested by an unregulated, overwhelming inflammation from the host in response to infection. Here, we exploit the use of a synthetic heparan sulfate octadecasaccharide (18-mer) to protect against sepsis. The 18-mer not only inhibits the pro-inflammatory activity of extracellular histone H3 and high mobility group box 1 (HMGB1), but also elicits the anti-inflammatory effect from apolipoprotein A-I (ApoA-I).

Multifunctional Quasi-Solid-State Zinc-Sulfur Battery.

The introduction of structural energy storage devices into emerging markets, such as electric vehicles, is predominately hindered by weak energy density, safety concerns, and immaturity of the field in materials. Herein, fabrication and testing of a freeze-resistant, multifunctional quasi-solid-state zinc-sulfur battery (ZnS) are reported. To this end, an electrostatic spray coating technique was used to deposit a thin layer of sulfur on the highly porous, unidirectional activated carbon nanofibers (A-CNFs) as a load-bearing cathode.

Life satisfaction and mental health from age 17 to 21 years in a general population sample.

Adolescence is a period when both mental health (MH) and wellbeing start deteriorating, which raises the question of how the two phenomena are linked and whether deterioration in one might be used to flag problematic developments in the other. While research shows that wellbeing and MH are associated, the direction of the association is not clear and longitudinal analyses, that might help disentangle the cause and effect, are scarce. Moreover, few studies have investigated the directional relation between MH and wellbeing early in the life course.