#INDIA COVID TRIAL#
Phase 2: Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial Lancet Infect Dis 2021.Phase II Human Clinical Trial COMPLETED.Phase 1: Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial Lancet Infect Dis 2021.Phase I Human Clinical Trial COMPLETED.
DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED.Th1 Skewed immune response of Whole Virion Inactivated SARS CoV 2 Vaccine and its safety evaluation iScience 24, 102298, April 23, 2021 Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques, Published at Nature Communication NATURE COMMUNICATIONS | (2021) 12:1386ģ. Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model iScience 24, 102054, February 19, 2021Ģ. Pre-clinical studies with small and large animals COMPLETED.ġ.The vaccine received approval from Drug Controller General of India (DCGI) for Phase I & II Human Clinical Trials and an Adaptive, Seamless Phase I, Followed by Phase II Randomized, Double blind, Multicentre Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility. COVAXIN TM, India's indigenous COVID-19 vaccine Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
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