ABSTRACT
BackgroundNanocovax is a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length prefusion stabilized recombinant SARS-CoV-2 spike glycoproteins (S-2P) and aluminum hydroxide adjuvant. In a Phase 1 and 2 studies, (NCT04683484) the vaccine was found to be safe and induce a robust immune response in healthy adult participants. MethodsWe conducted a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, immunogenicity, and protective efficacy of the Nanocovax vaccine against Covid-19 in approximately 13,007 volunteers aged 18 years and over. The immunogenicity was assessed based on Anti-S IgG antibody response, surrogate virus neutralization, wild-type SARS-CoV-2 neutralization and the types of helper T-cell response by intracellular staining (ICS) for interferon gamma (IFNg) and interleukin-4 (IL-4). The vaccine efficacy (VE) was calculated basing on serologically confirmed cases of Covid-19. FindingsUp to day 180, incidences of solicited and unsolicited adverse events (AE) were similar between vaccine and placebo groups. 100 serious adverse events (SAE) were observed in both vaccine and placebo groups (out of total 13007 participants). 96 out of these 100 SAEs were determined to be unrelated to the investigational products. 4 SAEs were possibly related, as determined by the Data and Safety Monitoring Board (DSMB) and investigators. Reactogenicity was absent or mild in the majority of participants and of short duration. These findings highlight the excellent safety profile of Nanocovax. Regarding immunogenicity, Nanocovax induced robust IgG and neutralizing antibody responses. Importantly, Anti S-IgG levels and neutralizing antibody titers on day 42 were higher than those of natural infected cases. Nanocovax was found to induce Th2 polarization rather than Th1. Post-hoc analysis showed that the VE against symptomatic disease was 51.5% (95% confidence interval [CI] was [34.4%-64.1%]. VE against severe illness and death were 93.3% [62.2-98.1]. Notably, the dominant strain during the period of this study was Delta variant. InterpretationNanocovax 25 microgram (mcg) was found to be safe with the efficacy against symptomatic infection of Delta variant of 51.5%. FundingResearch was funded by Nanogen Pharmaceutical Biotechnology JSC., and the Ministry of Science and Technology of Vietnam; ClinicalTrials.gov number, NCT04922788.
ABSTRACT
Background: Cystic hygromas is a common abnormal event in obstetrics ultrasound, which is induced by a chromosome disorder; it is also one of the major causes inducing fetus\u2019s congenital malformation. Objective: Determining chromosomal aberration in nuchal cystic hygromas by FISH technique and outcomes the value of factors in prognosis fetuses with cystic hygroma. Subject and methods: 53 fetuses with cystic hygroma, which are detected by ultrasound scan, are analyzed by FISH technique. Compare results of FISH, band G chromosomal analysis, ultrasonographic abnormalities, followed the fetuses. Results: Chromosomal and FISH analysis give the same detection: abnormal chromosomes: 75.46%, the highest rate is Turner syndrome: 50.94%, normal chromosome: 24.53%. Abnormal chromosomal fetuses: multi-malformation, grim prognosis. Cystic hygroma with other malformation in scan: high rate chromosomal aberrations and septated hygroma, Turner syndrome fetuses have large cystic hygroma, 4/6 fetuses with normal chromosome and without other abnormal result scan have resolutions of hygroma in the second trimester, normal birth. Conclusions: Abnormal chromosomes: 75.46%. Prognosis is grim: abnormal chromosomes, other malformations in scan, large cystic, septated hygroma. Prognosis is better: normal chromosomes, without other ultrasonographic abnormalities, small cystic, nonseptated hygroma, resolution of cystic hygroma.
Subject(s)
Lymphangioma, Cystic , In Situ Hybridization, Fluorescence , ChromosomesABSTRACT
Authors implemented the study to find characteristics of Doppler ultrasonic images in patients with HCC. This is a prospective study and carried out in B¹ch Mai Hospital. In the study on 15 patients, who had positive diagnosis of HCC, were selected. All of them underwent Doppler ultrasound and hepatic arteriography. Intra-tumoral and peri-tumoral flow is found with Doppler U.S 86.6% of tumors compared to the results of hepatic arteriography. The average peak velocity of hepatic artery and intratumoral artery is 83.3 and 57.2 cm/s respectively. The resistive Index is from 0.4 to 0.88 in intratumoural vessels.
