Summary Background Nanocovax 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. Methods We 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. Findings Up 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. Interpretation Nanocovax 25 microgram (mcg) was found to be safe with the efficacy against symptomatic infection of Delta variant of 51.5%. Funding Research was funded by Nanogen Pharmaceutical Biotechnology JSC., and the Ministry of Science and Technology of Vietnam; ClinicalTrials.gov number, NCT04922788 .
AIM:To study the potential association between hepatocellular carcinoma(HCC)in patients with chronic hepatitis C(CHC),cirrhosis and latent hepatitis B(LHB)infection,defined as the absence of detectable serum hepatitis B surface antigen(HBsAg)and the presence of hepatitis B core antibody(HBcAb).METHODS:This retrospective analysis is comprised of 185 cirrhotic patients with HCC who were hepatitis C virus antibody(HCV Ab)(+)and HBsAg(-)at Wayne State University between 1999 and 2008.From these,108 patients had HCV polymerase chain reaction confirmation of viremia while the remaining(77)were considered to have CHC on the basis of a positive HCV Ab and the absence of any other cause of liver disease.Controls were drawn from our institutional database from the same time period and consisted of 356 HBsAg(-)age,race and gender matched patients with HCV RNA-confirmed CHC and without evidence of HCC.A subgroup of controls included 118matched patients with liver cirrhosis.χ2test and t test were used for data analysis.RESULTS:Seventy-seven percent of patients in all3 groups were African Americans.Patients with HCC had a significantly higher body mass index(P=0.03),a higher rate of co-infection with human immunodeficiency virus(HIV)(P=0.05)and a higher prevalence of alcohol abuse(P=0.03)than the controls.More patients with HCC had LHB than controls(78%vs39%,P=0.01).Sixty three percent of patients with HCC were both hepatitis B surface antigen(HBsAb)(-)and HBcAb(+)compared to 23%of controls(P<0.01).When compared to cirrhotic controls,the frequency of HBcAb(+)remained higher in patients with HCC(78%vs 45%,P=0.02).Patients with HCC were more likely to be both HBsAb(-)and HBcAb(+)than the cirrhotic controls(63%vs 28%,P=0.01).Although not statistically significant,100%of CHC and HIV coinfected patients with HCC(n=11)were HBcAb(+)when compared to controls(44%;n=9).CONCLUSION:These data suggest that LHB occurs at a significantly increased frequency in patients with CHC and HCC than in patients with CHC without HCC.
We wished to establish anorectal functions in patients with spinal cord lesions, related to the level of lesion and its completeness. We also wished to determine the value of neurophysiological tests for completeness of transsections in comparison with manometry and visceral sensory testing. In 32 patients (31.5 ± 14.1 years, 25 males) with spinal trauma, completeness of transsection was assessed clinically. In 16 of these patients (30 ± 15.6 years, nine males), a neurological work‐up included recording of somatosensory evoked potentials (SEP) and motor evoked potentials (MEP) from the pudendal nerve within the first week after trauma. Also, anal sphincter EMG and pudendal nerve terminal motor latency (PNTML) were assessed. All patients also underwent conventional anorectal manometry and visceral sensory testing. Of all 32 patients, 15 were judged as `complete' based on their clinical signs. Of those 16 tested neurologically, seven were labelled `complete' since no MEP or SEP were detectable; one had pudendal SEP and MEP present, while SEP were present but delayed (47.0 ± 8.8 msec) in the remaining patients. In four of these patients, also MEP were recorded (27.9 ± 5.2 msec) and normal. PNTML was present in 12/16 patients independent of the completeness of lesion, and was rated normal in nine and delayed in three patients. EMG was normal in five, and pathological in 11 cases. In 5/15 cases of those judged as `complete' (in 3/7 evaluated neurologically), visceral sensory testing revealed a minimal threshold for rectal perception of distension of 44 mL (range: 10–130), which sometimes was also perceived as urge to defecate. In a further case, manometry showed major voluntary action of the anal sphincter. These patients had lesions at all levels of the spinal column, ranging from cervical (C4,C6,C7) via thoratical (2 × T7,T8,T12) to lumbar segments. Anorectal function testing, and specifically visceral sensory testing may be superior to neurological assessment of `completeness' of spinal cord lesions. It may be that visceral afferent pathways others than spinothalamic tract are involved in rectal perception that are less accessible to conventional neurophysiological diagnostic work‐up.
Demam Instagram mendorong Fujifilm untuk mengadopsi keinginan pasar akan ukuran foto berbentuk square. Usai merilis Instax Square SQ10 dengan Slot MicroSD tahun lalu, kini Fujifilm berinovasi melalui produk Instax analog mereka. Instax Square SQ6 hadir sebagai kamera square pertama bagi generasi Instax analog.pertama bagi generasi Instax analog.SQ6 memiliki berbagai variasi fungsi menarik, seperti Automatic Exposure, Double Exposure, Mode Macro, Mode Landscape, Selfie mode, dan Color Filter Attachment.
Introduction: Rural and remote health workforces face longstanding challenges in Australia. Little is known about the economic effectiveness of workforce initiatives to increase recruitment and retention. A two-level allied health rural generalist pathway was introduced as a workforce strategy in regional local health networks (LHNs) in South Australia in 2019. This research measured the resources and outcomes of the pathway following its introduction. Methods: A multi-phase, mixed-methods study was conducted with a 3-year follow-up period (2019–2022). A cost–consequence analysis was conducted as part of this study. Resources measured included tuition, time for quarantined study, supervision and support, and program manager salary. Outcomes measured included length of tenure, turnover data, career progression, service development time, confidence and competence. Results: Fifteen allied health professional trainees participated in the pathway between 2019 and 2022 and seven completed during this time. Trainees participated for between 3 and 42 months. The average total cost of supporting a level 1 trainee was $34,875 and level 2 was $70,469. The total return on investment within the evaluation period was $317,610 for the level 1 program and $58,680 for the level 2 program. All seven completing trainees continued to work in regional LHNs at the 6-month follow-up phase and confidence and competence to work as a rural generalist increased. Conclusion: This research found that the allied health rural generalist pathway has the potential to generate multiple positive outcomes for a relatively small investment and is therefore likely to be a cost-effective workforce initiative.
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