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A safe and effective vaccine against COVID-19 is urgently needed in quantities sufficient to immunise large populations. We report the preclinical development of two BNT162b vaccine candidates, which contain lipid-nanoparticle (LNP) formulated nucleoside-modified mRNA encoding SARS-CoV-2 spike glycoprotein-derived immunogens. BNT162b1 encodes a soluble, secreted, trimerised receptor-binding domain (RBD-foldon). BNT162b2 encodes the full-length transmembrane spike glycoprotein, locked in its prefusion conformation (P2 S). The flexibly tethered RBDs of the RBD-foldon bind ACE2 with high avidity. Approximately 20% of the P 2S trimers are in the two-RBD down, one-RBD up state. In mice, one intramuscular dose of either candidate elicits a dose-dependent antibody response with high virus-entry inhibition titres and strong TH1 CD4+ and IFN{gamma}+ CD8+ T-cell responses. Prime/boost vaccination of rhesus macaques with BNT162b candidates elicits SARS-CoV-2 neutralising geometric mean titres 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. The vaccine candidates protect macaques from SARS-CoV-2 challenge, with BNT162b2 protecting the lower respiratory tract from the presence of viral RNA and with no evidence of disease enhancement. Both candidates are being evaluated in phase 1 trials in Germany and the United States. BNT162b2 is being evaluated in an ongoing global, pivotal Phase 2/3 trial (NCT04380701, NCT04368728).
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To contain the coronavirus disease 2019 (COVID-19) pandemic, a safe and effective vaccine against the new severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is urgently needed in quantities sufficient to immunise large populations. In this study, we report the design, preclinical development, immunogenicity and anti-viral protective effect in rhesus macaques of the BNT162b2 vaccine candidate. BNT162b2 contains an LNP-formulated nucleoside-modified mRNA that encodes the spike glycoprotein captured in its prefusion conformation. After expression of the BNT162b2 coding sequence in cells, approximately 20% of the spike molecules are in the one-RBD up, two-RBD down state. Immunisation of mice with a single dose of BNT162b2 induced dose level-dependent increases in pseudovirus neutralisation titers. Prime-boost vaccination of rhesus macaques elicited authentic SARS-CoV-2 neutralising geometric mean titers 10.2 to 18.0 times that of a SARS-CoV-2 convalescent human serum panel. BNT162b2 generated strong TH1 type CD4+ and IFN{gamma}+ CD8+ T-cell responses in mice and rhesus macaques. The BNT162b2 vaccine candidate fully protected the lungs of immunised rhesus macaques from infectious SARS-CoV-2 challenge. BNT162b2 is currently being evaluated in a global, pivotal Phase 2/3 trial (NCT04368728).
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Background Macular edema following phacoemulsification with intraocular lens (IOL) implantation is a main factor to influent visual function.The administration of traditional medicine can relieve tissue edema,but its preventive and treatment efficacy on macular edema after phacoemulsification with IOL implantation remaines unclear.Objective This study was to investigate the protective effect of huoxuehuayu decoction on macula after phacoemulsification with IOL implantation.Methods A case-controlled observational study was designed.One hundred and eighty eyes of 150 patients with age-related cataract were randomized into operation group and operation + medicine group.Phacoemulsification with IOL implantation was performed in both groups,but huoxuehuayu decoction was orally administered for 14 days in operation+medicine group.The best corrected visual acuity,inflammatory reaction of the ocular anterior segment,and macular edema were recorded before operation and 1 week,2,4,6,8 and 12 weeks,and the central macular thickness was measured using optical coherence tomography.Results Twelve weeks after surgery,the ratio of visual acuity ≥ 1.0 was in significantly higher in operation+medition group than that of in operation group (x2 =1.066,P＞0.05).One week after surgery,the eyes of the aqueous flare were much nore in the operation group than that of operation+medicine group(x2 =9.341,P＜0.05).The thickness of the central fovea was significantly increased in both groups at 1 week,2,4,6,8 and 12 weeks after surgery,showing significant differences in comparison with preoperation (operation group:P ＜ 0.01 ; operation + medicine group:P ＜0.05).Macular edema occurred in 13 eyes in operation group during the following-up duration,including 11 eyes with thickened fovea and 2 eyes with cystoid macular edema.Maeular edema disappeared in 10 eyes 12 weeks later.In the operation+medition group,3 eyes happened macular edema,including thickened fovea in 2 eye and cystoid macular edema in 1 eye.Four to six weeks after surgery,macular edema disappeared in 3 eyes 12 weeks later.The fovea thickness in the operation+medicine group was statistically significantly lower from 2 through 8 weeks after surgery than that in the operation group(t=2.315,2.323,3.104,2.470,P＜0.05).Conclusions Oral administration of huoxuehuayu decoction is helpful for the restoration of the anterior ocular segment.Huoxuehuayu decoction can protect macula from the edema induced by phacoemulsification.
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AIM: To investigate the protective effect of huoxuehuayu decoction on macula after phacoemulsification. Into A, B groups. The 80 eyes of A group were treated by conventional phacoemulsification; the patients (60 eyes) of B group were given huoxuehuayu decoction orally for two courses after phacoemulsification. Best-corrected visual acuity(BCVA), corneal and aqueous conditions ,thickness of macular central fovea and changes of macular retinal tissue in A, B groups were observed before surgery, 1 day; 1 week,2,4,6,8 weeks and 3 months after surgery. Was significantly higher than that of group A. One week after surgery the ratio of mild aqueous flare in group B was significantly lower than that of group A. The thickness of central fixation was significantly increased in both groups 1 week, 2, 4, 6, 8 weeks and 3 months after phacoemulsification; the difference between 2 to 8 weeks after surgery and pre-operation showed statistical significance in both groups. 11 eyes in A group had macular edema during 2 to 6 weeks after surgery, including 9 eyes with fovea thickened and 2 eyes with cystoid macular edema, and seven eyes' edema disappeared in 3 months. 2 eyes in B group had macular edema, including 1 eye fovea thickened and 1 eye cystoid macular edema, during 4 to 6 weeks after surgery, and the two eyes' edema disappeared 3 months after surgery. The fovea thickness in group B during 2 to 8 weeks after surgery was statistically lower than group A. Phacoemulsification.
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AIM:To analyze the killing efficiency of six kinds of contact lens solutions and solutions with arilin on free living Acanthamoeba culturedin vitroMETHODS:Six kinds of contact lens solutions were added into 96-well microtiter plates,respectively,with each care solutions used 48 holes of them.Suspension of Acanthamoeba were added into 24 of these holes.and arilin gutta and suspension of Acanthamoeba were added into the other 24 holes.After standing in room ternperature for 8 hours,the morphologic change and quantity of the remnant Acanthamoeba were observed under the jnverted microscope.The remnant Acanthamoeba were cultivanted in peptone-yeast extract-glucose (PYG)-culture medium for 5 days.Their variation of appearance,activity and reproductive activity were observed.RESULTS:In the six experimental groups using contact lens solutions only.the detection rate of Acanthamoeba of were 0%,80.3%,29.1%,41.7%,62.5% and 79.2%,respectively.After arilin was added,the detection rate of Acanthamoeba of the six groups were 0%,0%,4.2%,8.3%,16.7% and 16.7%,respectively.From group 3 to group 6,after arilin was added,the differences of the killing efficiency of contact lens solutions have statistical significance(X2=3.75,7.11,10.54 and 18.78;P＜0.05).Cultivation of the remnant Acanthamoeba showed a reduction in the activity and proliferative ability.CONCLUSION:The killing efficiency of some contact lens solutions on free-living Acanthamoeba were not satisfying.Arilin can improve the killing efficiency of contact lens solutions.
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AIM: To compare the adherent ability of Acanthamoeba to three kinds of contact lens (CL) and survey the effect to remove the Acanthamoeba from the surface of contact lens after blowing with stroke-physiological saline solution (SPSS) repeatedly.METHODS: Three kinds of contact lens were chosen in this experiment, including: rigid gas permeable (RGP) contact lens, soft contact lens (SCL) and colored contact lens. They were co-cultivated with Acanthamoeba suspension for 16 hours. Then the number of Acanthamoeba adhered on CL was compared. Comparison was also made between different zones of colored CL. We also compared the number of Acanthamoeba adhered on CL in three groups after blowing with SPSS.RESULTS: The number of Acanthamoeba adhered to colored CL was more than RGP group and SCL group (P<0.05). The differences between RGP group and SCL group had no statistical significance (P>0.05). In colored CL group, the number of Acanthamoeba adhered to the colored zone was more than the Uncolored zone (P<0.01). In all the three groups, after blowing with SPSS, there was statistically significant decrease of the number of Acanthamoeba adhered to CL (P<0.01).CONCLUSION: Compared with RGP group and SCL group, the colored contact lens was more vulnerable to be adhered by Acanthamoeba. After being blown by SPSS repeatedly, the effect to eliminate Acanthamoeba has been improved greatly.