New England Center for Clinical Research

Background4CMenB (MenB-4C, GSK) has been licensed in the US since 2015 for individuals aged 10–25 years. This study assessed its safety and immunogenicity in US infants when administered concomitantly with PCV13 (Pfizer) and other US-recommended RIVs.MethodsThis phase 3B, observer-blind, randomized, placebo-controlled, multicenter study (NCT03621670) randomized (2:1 ratio) 1195 healthy US infants aged 6–12 weeks to receive, at approx. 2, 4, 6, and 12 months of age, either 4CMenB administered concomitantly with PCV13 and other RIVs (N=786; 4CMenB+RIVs) or placebo with PCV13 and other RIVs (N=409; Placebo+RIVs). Primary objectives were to assess vaccine safety, demonstrate sufficiency of immune responses to 4CMenB by human serum bactericidal assay (hSBA) against each of 4 serogroup B (MenB) indicator strains and all strains combined (composite), and non-inferiority of pneumococcal serotype-specific geometric mean antibody concentrations (GMCs).ResultsPre-specified sufficiency criteria 1 month post-dose 3 (based on lower limit [LL] of 99.2% confidence interval [CI] for hSBA titers ≥lower limit of quantitation [LLOQ]) and post-dose 4 (based on LL of 95.8% CI for hSBA titers ≥8/16) were met for fHbp, NadA, and PorA strains, but not for NHBA and the composite response. For NHBA, the CI LL for percentage of participants with hSBA titers ≥8 post-dose 4 was 72.5% (sufficiency criterion: ≥75%). Percentages of participants with hSBA titers ≥LLOQ against each MenB indicator strain post-dose 4 were 86.1%–99.6% (75.7%, composite) in the 4CMenB+RIVs group vs 0.0%–2.8% (0.0%, composite) in the Placebo+RIVs group. The success criterion for immunological non-inferiority of PCV13 (4CMenB+RIVs) vs PCV13 (Placebo+RIVs) was met for each PCV13 antigen (see table). 4CMenB was well tolerated, with no major between-group differences in unsolicited adverse events and no safety concerns identified.Conclusion4CMenB was well tolerated and immunogenic in US infants, with no clinically significant interference against concomitantly administered RIV. Comparison against the 4CMenB-naïve group shows MenB immune responses in the 4CMenB+RIVs group were elicited solely by 4CMenB.Acknowledgements: Enovalife Medical Communication Service Center, on behalf of GSK (writer: J. Knowles).Funding: GSK.DisclosuresAll Authors: No reported disclosures

The US Naval Research Laboratory (NRL) is the world leader in the development of high energy excimer laser science and technology [1] . The argon fluoride (ArF*) laser can be scaled in power and energy to become a good candidate for direct or indirect driver for inertial confinement fusion (ICF). The deep UV light (193 nm) provides uniform target irradiation and broad native bandwidth (5 to 10 THz), suppresses laser plasma instabilities, and has intrinsic efficiency of more than 16 %. In this work we present the progress in modeling the kinetics and radiation of an electron beam ( e -beam) pumped ArF* laser relevant to NRL Electra facility. The modeling is based on the NRL Orestes suit of codes. The most important parameters used for guiding the experiments and monitoring the Orestes predictive capabilities are the laser yield and ASE. Here we present some numerical simulations for 0.5–1 MW⁄cm 3 e -beam power and total pressure 12–20 psi. We scan the range of pressures for which experiments are typically performed [2] . The ASE is a small fraction of the laser yield, on the order of 1-10 %. The numerical simulations show that the laser yield is not very sensitive to total pressure, which should be close to 1 atm, but very sensitive to F 2 content: maximum lasing is observed at 0.5±0.2% F 2 in Ar. The laser yield increases with e -beam power deposition until it reaches an optimum e -beam power beyond which the lasing decreases because most of the ArF* molecules are dissociated by electron impact or lost in neutral-neutral collisons with Ar and F 2 .

All pulse sequences start off with an excitation RF pulse and a slice select gradient applied simultaneously. Spin echo is the backbone of MRI. Its structure again is: a 90 degrees RF slice excitation pulse followed by a 180 degrees RF slice refocusing pulse. An echo (a spin echo) results from the effects of the 180 degrees RF pulse. Main magnetic field inhomogeneities are larger inconsistencies of the main magnetic field. Causes could be service-related issues such as the field shim drifting or metallic foreign objects being drawn into the bore. The basic gradient recalled echo pulse sequence diagram starts off just like an spin echo with a slice select excitation pulse, which is usually something less than 90 degrees but can be as much as 90 degrees. The Ernst angle is not often used or mentioned in MRI. It is more often used at 3 T for better T1 contrast.

Salivary glands may give rise to a wide spectrum of different tumors. This review concentrates on 4 salivary gland tumors that have been accepted in the recent literature as new neoplastic entities: mammary analog secretory carcinoma, cribriform adenocarcinoma of minor salivary glands (CASG), sclerosing polycystic adenosis/adenoma (SPA), and the mucinous/secretory variant of myoepithelioma. Mammary analog secretory carcinoma is a distinctive low-grade malignant salivary cancer that harbors a characteristic chromosomal translocation, t(12;15) (p13;q25), resulting in an ETV6-NTRK3 fusion. Cribriform adenocarcinoma (CASG) is a distinct tumor entity that differs from polymorphous low-grade adenocarcinoma by location (ie, most often arising on the tongue), by prominent nuclear clearing, differing alterations of the PRKD gene family, and clinical behavior with frequent metastases at the time of presentation of the primary tumor. Early nodal metastatic disease is seen in most cases of CASG; yet, they are still associated with indolent clinical behavior, making it a unique neoplasm among all low-grade salivary gland tumors. SPA is a rare sclerosing tumor of the salivary glands characterized by the combination of cystic ductal structures with variable cell lining including vacuolated, apocrine, mucinous, squamous, and foamy cells, by prominent large acinar cells with coarse eosinophilic cytoplasmic zymogen-like granules, and by closely packed ductal structures, surrounded by a peripheral myoepithelial layer and stromal fibrosis with focal inflammatory infiltrates. SPA frequently harbors intraductal epithelial dysplastic proliferations ranging from mild dysplasia to severe dysplasia/carcinoma in situ. Moreover, SPA has been proven to be a clonal process by HUMARA assay and is associated with considerable risk of recurrence. Therefore, on the basis of all these newly recognized findings, we believe that SPA is likely a neoplasm, and we suggest the name "sclerosing polycystic adenoma." The mucinous variant of myoepithelioma is a myoepithelial tumor with foci of prominent cytoplasmic clearing frequently containing intracellular mucin material and having signet-ring morphology.

The purpose of this research study was to evaluate the effects of plant type and production parameters on the stiffness, performance, and degree of blending between the aged and virgin binders of plant-produced reclaimed asphalt pavement (RAP) mixtures. Mixtures from a batch and a drum plant and the corresponding production information were obtained. The stiffness of each mixture was evaluated by measuring the dynamic modulus. Moisture susceptibility and rutting potential were evaluated with the Hamburg wheel tracking device. Low-temperature cracking characteristics were evaluated with the asphalt concrete cracking device. Finally, the workability of the mixtures was evaluated with an asphalt workability device. Binder was extracted from each mixture to measure the degree of blending between the aged and virgin binder. The degree of blending between the aged RAP and virgin binder in each mixture was evaluated with an analysis approach that used the ratio of the mixture dynamic modulus to the recovered binder shear modulus. Batch and drum plants produced RAP mixtures that performed similarly to the control mixtures and exhibited good blending. None of the RAP mixture tested showed increased susceptibility to moisture damage, rutting, and low-temperature cracking susceptibility as the RAP content was increased. Workability testing identified a potential construction issue as the mixture workability decreased as the amount of RAP in the mixture increased. Finally, the performance data indicated the importance of the proper virgin binder grade selection for mixtures with higher amounts of RAP.

The piezoelectric bender bar vibrator is commonly used for generating low frequency flexural plate mode vibrations. This study considers the excitation of “benders” using stripe-electroded piezoelectric elements of various electrode patterns and poling configurations using the k3'3 and k3'1, where the prime indicates field nonuniformity. A numerical analysis is used to calculate the nonuniform electric field lines and the corresponding coupling coefficients as well as other related electromechanical parameters by developing a Lagrangian description of the electromechanical body and using the energy method. The effective electromechanical coupling coefficients are calculated by taking into account the internal energies due to transverse, longitudinal, and shear vibrations in the bar. The contribution of the passive and the active capacitance is also explained and taken into account while calculating the electromechanical parameters.

Tangentially poled thin-walled stripe-electroded piezoelectric bars and hollow cylinders are used in several electromechanical and electroacoustic applications. The 33 mode properties of the stripe-electroded bars and hollow cylinders are not fully realized due to the non-uniform polarization and non-uniform operational electric field due to fringing from the surface electrode geometry. A numerical finite difference method (FDM) was used to analyze the nonuniform electric field in the bar but under the assumption that the piezoelectric element is fully polarized. The effective electromechanical coupling coefficient k3'3, the effective piezoelectric modulus d3'3, the effective compliance sE3'3, and the effective relative dielectric constant ε3'3 (where the prime indicates field nonuniformity) are calculated using the energy method by accounting for the effects of nonuniform operational electric field and non uniform strain distributions. Analytical and experimental results are in good agreement and design optimizations are presented.