Immunogenicity and safety of Biological E's CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial.

Adult Humans Adolescent Young Adult Middle Aged Aged Aged, 80 and over ChAdOx1 nCoV-19 COVID-19 Vaccines / adverse effects Leukocytes, Mononuclear Prospective Studies Single-Blind Method COVID-19 / prevention & control SARS-CoV-2 Vaccines Immunogenicity, Vaccine Antibodies, Viral Antibodies, Neutralizing Double-Blind Method

Covid-19 SARS-Cov-2 protein subunit receptor binding domain spike protein vaccine

Journal

Human vaccines & immunotherapeutics

ISSN: 2164-554X

Titre abrégé: Hum Vaccin Immunother

Pays: United States

ID NLM: 101572652

Informations de publication

Date de publication:
31 12 2023

Historique:

medline: 28 6 2023

pubmed: 28 4 2023

entrez: 28 4 2023

Statut: ppublish

Résumé

Optimum formulation of Biological-E's protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18-80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ (

Identifiants

DOI: 10.1080/21645515.2023.2203632 PMID: 37113012 PMC: PMC10294721

pubmed: 37113012

doi: 10.1080/21645515.2023.2203632

pmc: PMC10294721

doi:

Substances chimiques

ChAdOx1 nCoV-19 B5S3K2V0G8

COVID-19 Vaccines 0

Vaccines 0

Antibodies, Viral 0

Antibodies, Neutralizing 0

Banques de données

CTRI

['CTRI/2021/08/036074']

Types de publication

Randomized Controlled Trial Multicenter Study Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

2203632

Références

Biochim Biophys Acta Gen Subj. 2021 Jun;1865(6):129893

pubmed: 33731300

Hum Vaccin Immunother. 2021 Aug 3;17(8):2356-2366

pubmed: 33847226

J Infect Dis. 2022 Jan 18;225(2):327-331

pubmed: 34888662

Nature. 2020 Oct;586(7830):572-577

pubmed: 32726802

Nature. 1984 Jan 12-18;307(5947):178-80

pubmed: 6318124

Protein Expr Purif. 2022 Feb;190:106003

pubmed: 34688919

Vaccine. 2020 Nov 3;38(47):7533-7541

pubmed: 33039209

Nat Protoc. 2021 Jun;16(6):3114-3140

pubmed: 33893470

EBioMedicine. 2022 Sep;83:104217

pubmed: 35970020

SN Compr Clin Med. 2020;2(8):1069-1076

pubmed: 32838147

Appl Microbiol Biotechnol. 2021 May;105(10):4153-4165

pubmed: 33959781

Nature. 2020 Oct;586(7830):516-527

pubmed: 32967006