The Indian Pharmaceutical Serum Institute of India has introduced phase 2 and 3 clinical trials to assess the protection and immune reaction of the coronavirus vaccine candidate in healthy Indian adults after the pharmaceutical company received approval from the Indian Drug Controller (DCGI) before this month.
According to the Clinical Trial Registry India, the clinical name of the study indicates that the Phase 2/3 clinical trial will be a controlled, randomized and blindly controlled study to determine the protection and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indians. Adults.
A total of 1,600 eligible participants over the age of 18 will be enrolled in the study, which will be held at 17 sites in India.
These include: Andhra Medical College (Visakhapatnam), JSS Academy of Higher Education and Research, (Mysore), Seth GS Medical College and KEM Hospital (Mumbai), KEM Hospital Research Center (Vadu), BJ Medical College and Sassoon General Hospital (Pune), All India Institute of Medical Sciences (Jodhpur), Rajendra Memorial Research Institute of Medical Sciences, (Patna), Institute of Community Medicine (Madras), Post Graduate Institute of Medical Education – Research (PGIMER) Array Bharati , Jehangir Hospital (Pune), AIIMS (Delhi), ICMR – Regional Medical Research Center (Gorakhpur), TN Medical College – BYL Nair Hospital (Mumbai), Mahatma Gandhi Institute of Medical Sciences (Sewagram) and Government Medical College (Nagpur).
Of the 1,600 eligible icipantes in total, 400 icipantes will be from the immunogenicity cohort and randomly allocated in a ratio of 3:1 to obtain COVISHIELD or Oxford / AZ-ChAdOx1 nCoV-19 respectively.
The remaining 1200 participants in the protection cohort will be randomly assigned in a ratio of 3:1 to obtain COVISHIELD or Placebo respectively.
The Indian Clinical Trials Register indicates that Covishield (COVID-19 vaccine) will be administered in 2 doses on day 1 and 29 in doses of 0.5 ml intramuscularly.
“The Oxford/AZ-ChAdOx1NcOV-19 vaccine will be given as a 2 dose on days 1 and 29 as an intramuscular dose of 0.5 ml,” he said.
“The placebo will be administered in 2 doses on days 1 and 29 intramuscularly,” he added.
The clinical examination is based on two criteria: inclusion and exclusion.
Healthy adults older than 18 years of age of any sex will participate in the inclusion criteria. Informed written consent must be received through the participants and must be residents of the examination domain and be willing to meet the needs of the examination protocol. Healthy as decided through medical history and physical examination. Women of childbearing potential deserve a negative urine pregnancy test 24 hours before the vaccine is given.
In addition, the exclusion criteria imply that participants with or without fever will be excluded from an acute disease at the time of the handling of the vaccine under study. People with a history of COVID-19 disease shown in the circle of the family contact lab or close contact at the office will not enroll in the exam. Participants with an HIV-positive IgG prestige in SARS-Cov2 and with a background or lately positive for SARS-CoV-2 through RT-PCR will not be able to participate.
It also indicates that volunteers with a history of severe allergic reactions after past vaccines or a hypersensitivity reaction to any part of the test vaccine and any conditions shown or suspected with an altered or altered immune formula serve as not participating in the test.
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