Phase III trial of indigenously developed kovacine of Corona, Gujarat Medical Education and Research Society (GMERS), Ahmedabad
Volunteers should be between 18 and 60 years old for a third phase trial and should be perfectly healthy. According to investigators, there are several warnings that need to be kept in mind. For example, volanteers should not be covid-19 positive nor have they ever had a corona infection before. At the same time, vaccine volunteers may not be infected with HIV or hepatitis.
Investigators said, “If women are voluntary, then they should not be pregnant and agree not to conceive during the durations of the trial.” In addition, only 20 per cent of the volunteers may be diabetic and blood pressure patients but they should also be within the acceptable limits of the centrally prescribed protocol. According to the protocol, up to 5 per cent can be recruited from health workers.
If prospective volunteers fit all of these criteria, they can move to room number 1 of the OPD of GMERS and urge them to become volunteers for the clinical trial of covicin. They will be given further advice and fill in the consent form to pass the screening test.
Principal Investigator of the Medical College, Dr. Parul Bhatt said that after selection, it takes one hour to complete the trial process. In this
One also has to sit for 30 minutes after getting a vaccine dose. Two intramuscular injections of 10 mL will be given to each volunteer. One injection will be given on the first day and second injection will be given 28 days later.
Volunteers will have to go to the hospital for routine checkup once every month for the next 10 months. They will be paid a token amount on each visit. Dr. Parul also states that volunteers should be fully aware that this is merely a trial and not a vaccine, so they will have to maintain safety measures to avoid corona further.
Dr. Bhatt said, ‘We can only enroll educated and healthy people who can read the consent form and understand the rules of the trial. Also, we will need a signature in their form. The thumb impression will not be recognized.
At JEMRS, 10 volunteers have passed the screening test and are now eligible to be part of the research. Dr. Parul said, “5 of these people have given their consent and the other 5 people are reading the 10-page concurrent form right now.”
According to the website of the Clinical Trial Registry of India, Bharat Biotech Company of Telangana has developed Kovaxin and is funded by ICMR. 500 doses of vaccine have been delivered for trial at Sola Civil Hospital. Investigators say that 1,000 volunteers will be enrolled for the research.
However, this is a double blind randomized controlled trial, so doctors do not even know which vial contains covaxine and which vial contains placebo. In other words, the vaccine is being tested on volunteers to check for any adverse reactions or effective in building immunity to fight corona.
If there are adverse reactions to the vaccine, then what is the preparation of the hospital. On this, Dr. Parul says that in a trial of another vaccine candidate, pain, headache and fever have been noticed at the point of injection within 24 hours. She further says that in such a situation, the Volunteers can come to the hospital and get their treatment in addition to the phone conversation. Volunteers will also have insurance.
If in the middle of the trial Volantier gets infected with Corona, then in such a situation, Dr. Parul says that Volunteer will not be given another dose. He told that if Kovid-19 is infected after giving both doses, in such a situation it will not be removed from the trial but the results will be monitored. They will also be given Kovid-19 treatment.