Clinical trial of COVID 19 COVAXIN vaccine on Human starts at Bhubaneswar on 22 JULY
Clinical Trials on Human
The human clinical trials involving 4 phases containg phase 1 to phase 4 and it also contains preclinical trial. The human clinical trials of COVID 19 COVAXIN derived from a strains of SARS CoV 2 isolated by ICMR NIV National Institute of Virology at Pune (developed by BHARAT BIOTECH is one of the lead innovative hyderabad based company). India 's indigenously developed coronavirus vaccine is starts its clinical trial on human form tomorrow i.e. 22 July, at a Bhubaneswar based institute.
They said ,the requirements and screening of volunteers had started; after screening, we will select healthy individuals between the age of 18 and 55 years for the first phase of human trials. After the completion of first human trials the volunteers will be in contact with us for two to three months. And they said the candidates are under monitoring and they will be in proper touch with us; we will also call them and to test antibody level in their blood after taking the vaccination, if the process will sufficient then we will go for the second and third phase of trials..
The Indian Council of Medical Research and Bharat Biotech are collaborate for working of the preclinical trial as well as clinical development of this vaccine and also gets approval for phase 1 and phase 2 truals by the Drug Controller General of India (DCGI).
The professor G Sahoo, Dean, at IMS(Institute of Medical Sciences) and SUM hospital, Bhubaneswar talking about the processing of chosen of 30 to 40 candidates for the first phase of the human clinical trials from July 22.
Additionally, the principal investigator for the trials of covid 19 Dr. Venkat Rao, "We are committed to the maintenance of quality, ethics, patient safety,risk management process of the patient and confidentiality. We conduct clinical trials involving investigational drugs/ molecules approved by the DCGI and CDSCO (Central Drug Standard Control Organization)
The special laboratory --- Preventive and Therapeutic Clinical Trial Unit (PTCTU) under its department of community medicine was inaugurated at the IMS SUM hospital, Bhubaneswar by the Dean Sahoo and also said all necessary arrangements have been made for conducting human clinical trials.
And they said all the four phases of clinical trials on human subjects would be conducted at the same center. And the healthy volunteers who will wish to join the trials can contact the institution to register the website http://ptctu.soa.ac.in/ and they also contact 8917211214 through watsapp.
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