Page 51 - தகவல்கள் பாதுகாப்பு கண்காணிப்பு பலகை News Today : Breaking News, Live Updates & Top Stories | Vimarsana
Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate – IT Business Net
itbusinessnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from itbusinessnet.com Daily Mail and Mail on Sunday newspapers.
VLA2001 COVID-19 Vaccine Description
VLA2001 is a Vero-cell-based, highly purified inactivated vaccine candidate against the novel coronavirus SARS-CoV-2 that causes COVID-19 in humans. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018.
Valneva SE s adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shown a shift of the cellular immune response towards Th1. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese Encephalitis Vaccine, IXIARO®. The process, which has already been upscaled to the final industrial scale, includes inactivation with BPL to preserve the native structure. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.
CureVac has announced today the enrollment of the first participant in the pivotal Phase 2b/3 study of its messenger ribonucleic acid (mRNA) vaccine candidate, CVnCoV, against COVID-19.
The randomized, observer blind, placebo-controlled Phase 2b/3 trial called HERALD will assess the safety and efficacy of CVnCoV in subjects 18 years or older at a dose of 12 micrograms.
The study is expected to include more than 35,000 participants at sites in Europe and Latin America, said the Tübingen, Germany headquartered company.
CureVac intends to initiate a rolling submission with the European Medicines Agency (EMA) in the first quarter of 2021 based on initial analysis of data from the pivotal study, a spokesperson for the German biotech told BioPharma-Reporter.
The ARREST trial was funded by the National Heart, Lung and Blood Institute under the National Institutes of Health.
From Aug. 8, 2019 to June 14, about 30 patients participated. When they arrived at the hospital, they were randomly selected to either get the standard of care or the new treatment, Yannopolous said.
The standard of care has been CPR, defibrillation, intubation and intravenous medications.
Only one of 15 people who received the standard of care survived compared to six of the 14 who received ECMO-facilitated resuscitation as part of the system of care.
“We were following patients up to six months and we have had all six survivors survive after six months and none of the standard group survived,” Yannopolous said. “As a magnitude of intervention is one of the largest positive trials that have ever been recorded in cardiology in resuscitation science.”
Polyphor Announces Third Positive Data Safety Monitoring Board (DSMB) Recommendation to Continue Phase III balixafortide FORTRESS Study Without Modifications – IT Business Net
itbusinessnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from itbusinessnet.com Daily Mail and Mail on Sunday newspapers.
vimarsana © 2020. All Rights Reserved.