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Kochhar, Sonali,Excler, Jean-Louis,Bok, Karin,Gurwith, Marc,McNeil, Michael M.,Seligman, Stephen J.,Khuri-Bulos, Najwa,Klug, Bettina,Laderoute, Marian,Robertson, James S.,Singh, Vidisha,Chen, Robert T Elsevier Ltd. 2019 Vaccine Vol. No.
<P><B>Abstract</B></P> <P>Live viral vectors that express heterologous antigens of the target pathogen are being investigated in the development of novel vaccines against serious infectious agents like HIV and Ebola. As some live recombinant vectored vaccines may be replication-competent, a key challenge is defining the length of time for monitoring potential adverse events following immunization (AEFI) in clinical trials and epidemiologic studies. This time period must be chosen with care and based on considerations of pre-clinical and clinical trials data, biological plausibility and practical feasibility. The available options include: (1) adapting from the current relevant regulatory guidelines; (2) convening a panel of experts to review the evidence from a systematic literature search to narrow down a list of likely <I>potential or known</I> AEFI and establish the optimal risk window(s); and (3) conducting “near real-time“ prospective monitoring for <I>unknown</I> clustering’s of AEFI in validated large linked vaccine safety databases using Rapid Cycle Analysis for pre-specified adverse events of special interest (AESI) and Treescan to identify previously unsuspected outcomes. The risk window established by any of these options could be used along with (4) establishing a registry of clinically validated pre-specified AESI to include in case-control studies. Depending on the infrastructure, human resources and databases available in different countries, the appropriate option or combination of options can be determined by regulatory agencies and investigators.</P>
Immune correlates of protection for dengue: State of the art and research agenda
Katzelnick, Leah C.,Harris, Eva,Baric, Ralph,Coller, Beth-Ann,Coloma, Josefina,Crowe Jr., James E.,Cummings Jr., Derek A.T.,Dean Jr., Hansi,de Silva Jr., Aravinda,Diamond Jr., Michael S.,Durbin Jr., A Elsevier 2017 Vaccine Vol.35 No.36
<P><B>Abstract</B></P> <P>Dengue viruses (DENV1-4) are mosquito-borne flaviviruses estimated to cause up to ∼400 million infections and ∼100 million dengue cases each year. Factors that contribute to protection from and risk of dengue and severe dengue disease have been studied extensively but are still not fully understood. Results from Phase 3 vaccine efficacy trials have recently become available for one vaccine candidate, now licensed for use in several countries, and more Phase 2 and 3 studies of additional vaccine candidates are ongoing, making these issues all the more urgent and timely. At the “<I>Summit on Dengue Immune Correlates of Protection</I>”, held in Annecy, France, on March 8–9, 2016, dengue experts from diverse fields came together to discuss the current understanding of the immune response to and protection from DENV infection and disease, identify key unanswered questions, discuss data on immune correlates and plans for comparison of results across assays/consortia, and propose a research agenda for investigation of dengue immune correlates, all in the context of both natural infection studies and vaccine trials.</P>
Unstitching the Nanoscopic Mystery of Zeolite Crystal Formation
Brent, Rhea,Cubillas, Pablo,Stevens, Sam M.,Jelfs, Kim E.,Umemura, Ayako,Gebbie, James T.,Slater, Ben,Terasaki, Osamu,Holden, Mark A.,Anderson, Michael W. American Chemical Society 2010 JOURNAL OF THE AMERICAN CHEMICAL SOCIETY - Vol.132 No.39
<P>A molecular-scale understanding of crystal growth is critical to the development of important materials such as pharmaceuticals, semiconductors and catalysts. Only recently has this been possible with the advent of atomic force microscopy that permits observation of nanoscopic features on solid surfaces under a liquid or solution environment. This allows <I>in situ</I> measurement of important chemical transformations such as crystal growth and dissolution. Further, the microscope can access not only an accurate height measurement of surface topography, important to deduce structural elements, but also the forces involved during nanoscopic processes. We have discovered that it is possible to use these features to “illuminate” critical nanoscopic chemical events at crystal surfaces and at the same time extract the associated energies and unstitch the details of the stepwise mechanism of growth and dissolution. This approach has been developed using nanoporous crystals of the heterogeneous catalyst zeolite L; however, in principle the approach could be adapted to many crystal growth problems.</P><P><B>Graphic Abstract</B> <IMG SRC='http://pubs.acs.org/appl/literatum/publisher/achs/journals/content/jacsat/2010/jacsat.2010.132.issue-39/ja105593v/production/images/medium/ja-2010-05593v_0015.gif'></P><P><A href='http://pubs.acs.org/doi/suppl/10.1021/ja105593v'>ACS Electronic Supporting Info</A></P>
Galecio-Castillo Milagros,Farooqui Mudassir,Hassan Ameer E.,Jumaa Mouhammad A.,Divani Afshin A.,Ribo Marc,Abraham Michael,Petersen Nils H.,Fifi Johanna T.,Guerrero Waldo R.,Malik Amer M.,Siegler James 대한뇌졸중학회 2023 Journal of stroke Vol.25 No.3
Background and Purpose Effect of endovascular therapy (EVT) in acute large vessel occlusion (LVO) patients with tandem lesions (TLs) within 6–24 hours after last known well (LKW) remains unclear. We evaluated the clinical and safety outcomes among TL-LVO patients treated within 6–24 hours. Methods This multicenter cohort was divided into two groups, based on LKW to puncture time: early window (<6 hours), and late window (6–24 hours). Primary clinical and safety outcomes were 90-day functional independence measured by the modified Rankin Scale (mRS: 0–2) and symptomatic intracranial hemorrhage (sICH). Secondary outcomes were successful reperfusion (modified Thrombolysis in Cerebral Infarction score ≥2b), first-pass effect, early neurological improvement, ordinal mRS, and in-hospital and 90-day mortality. Results Of 579 patients (median age 68, 32.1% females), 268 (46.3%) were treated in the late window and 311 (53.7%) in the early window. Late window group had lower median National Institutes of Health Stroke Scale score at admission, Alberta Stroke Program Early Computed Tomography Score, rates of intravenous thrombolysis, and higher rates for perfusion imaging. After adjusting for confounders, the odds of 90-day mRS 0–2 (47.7% vs. 45.0%, adjusted odds ratio [aOR] 0.71, 95% confidence interval [CI] 0.49–1.02), favorable shift in mRS (aOR 0.88, 95% CI 0.44–1.76), and sICH (3.7% vs. 5.2%, aOR 0.56, 95% CI 0.20–1.56) were similar in both groups. There was no difference in secondary outcomes. Increased time from LKW to puncture did not predicted the probability of 90-day mRS 0–2 (aOR 0.99, 95% CI 0.96–1.01, for each hour delay) among patients presenting <24 hours. Conclusion EVT for acute TL-LVO treated within 6–24 hours after LKW was associated with similar rates of clinical and safety outcomes, compared to patients treated within 6 hours.