Phase 1 Randomized, Placebo-Controlled, Study to Compare the Safety, Reactogenicity, and Immunogenicity of a Full-Strength Formulation of Trivalent Salmonella (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV), a Half-Strength Formulation of TSCV, and a Dilutional Half-Strength Dose of TSCV Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults

This is a randomized, placebo-controlled interventional study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.

开始日期2022-08-15

申办/合作机构

University of Maryland Baltimore

100 项与 Trivalent Salmonella Conjugate Vaccine(University of Maryland, Baltimore) 相关的临床结果

登录后查看更多信息

100 项与 Trivalent Salmonella Conjugate Vaccine(University of Maryland, Baltimore) 相关的转化医学

登录后查看更多信息

100 项与 Trivalent Salmonella Conjugate Vaccine(University of Maryland, Baltimore) 相关的专利（医药）

登录后查看更多信息

项与 Trivalent Salmonella Conjugate Vaccine(University of Maryland, Baltimore) 相关的文献（医药）

2020-04-01·European Archives of Oto-Rhino-Laryngology3区 · 医学

Feasibility of ovine and porcine models for simulation training in parotid surgery and facial nerve dissection

3区 · 医学

Article

作者: Kunanandam, Thushitha ; Clement, William A ; Milner, Thomas D ; McGuigan, Mark ; Okhovat, Saleh

PURPOSETo assess and compare the feasibility of using ovine and porcine models as surgical simulation training tools for otolaryngology trainees performing parotid surgery and facial nerve dissection.METHODSTrainees performed parotid surgery (total parotidectomy, retrograde facial nerve dissection and facial nerve grafting) on an ovine and porcine model. Participants completed a 22-item, five-point Likert scale questionnaire on each model, assessing three validation domains; face validity (FV), global content validity (GCV) and task-specific content validity (TSCV). Data were prospectively collected and analysed using descriptive and non-parametric statistics.RESULTSTwelve trainees completed two consecutive parotidectomies and facial nerve dissections on an ovine and porcine model. Twenty-four dissections were completed. Validation questionnaires were completed for each model by all trainees. The ovine model achieved median validation threshold scores (≥ 4/5) for all aspects of FV, GCV and TSCV. The porcine model did not achieve validation threshold scores for any aspect of the validation questionnaire. Comparison of the ovine and porcine model demonstrated that the ovine model was statistically superior to the porcine model across most validation criteria excluding realistic appearance of skin, identification and ligation of the trans-oral parotid duct and facial nerve grafting.CONCLUSIONAdequate experience with facial nerve dissection during parotid surgery is vital to ensuring good outcomes and avoiding complications. This study is the first to compare validity of two animal models for simulation training in parotid surgery and facial nerve dissection. We have validated the ovine model as a useful tool for simulation training and advocate its incorporation into otolaryngology training programmes.

PLOS ONE3区 · 综合性期刊

Burden of Invasive Group B Streptococcus Disease and Early Neurological Sequelae in South African Infants

3区 · 综合性期刊

ArticleOA

作者: Nakwa, Firdose ; Fredericks, Joy ; Koen, Anthonet ; Wadula, Jeannette ; Cutland, Clare L ; Ramdin, Tanusha ; Madhi, Shabir A ; Jose, Lisa ; Lala, Sanjay G ; Dangor, Ziyaad

INTRODUCTIONGroup B Streptococcus (GBS) is a leading cause of neonatal sepsis and meningitis. We aimed to evaluate the burden of invasive early-onset (0-6 days of life, EOD) and late-onset (7-89 days, LOD) GBS disease and subsequent neurological sequelae in infants from a setting with a high prevalence (29.5%) of HIV among pregnant women.METHODSA case-control study was undertaken at three secondary-tertiary care public hospitals in Johannesburg. Invasive cases in infants <3 months age were identified by surveillance of laboratories from November 2012 to February 2014. Neurodevelopmental screening was done in surviving cases and controls at 3 and 6 months of age.RESULTSWe identified 122 cases of invasive GBS disease over a 12 month period. Although the incidence (per 1,000 live births) of EOD was similar between HIV-exposed and HIV-unexposed infants (1.13 vs. 1.46; p = 0.487), there was a 4.67-fold (95%CI: 2.24-9.74) greater risk for LOD in HIV-exposed infants (2.27 vs. 0.49; p<0.001). Overall, serotypes Ia, Ib and III constituted 75.8% and 92.5% of EOD and LOD, respectively. Risk factors for EOD included offensive draining liquor (adjusted Odds Ratio: 27.37; 95%CI: 1.94-386.50) and maternal GBS bacteriuria (aOR: 8.41; 95%CI: 1.44-49.15), which was also a risk-factor for LOD (aOR: 3.49; 95%CI: 1.17-10.40). The overall case fatality rate among cases was 18.0%. The adjusted odds for neurological sequelae at 6 months age was 13.18-fold (95%CI: 1.44-120.95) greater in cases (13.2%) than controls (0.4%).DISCUSSIONThe high burden of invasive GBS disease in South Africa, which is also associated with high case fatality rates and significant neurological sequelae among survivors, is partly due to the heightened risk for LOD in infants born to HIV-infected women. An effective trivalent GBS conjugate vaccine targeted at pregnant women could prevent invasive GBS disease in this setting.

100 项与 Trivalent Salmonella Conjugate Vaccine(University of Maryland, Baltimore) 相关的药物交易

登录后查看更多信息