Kolkata: Chiranjit Dhibar, the 30-year-old teacher from Durgapur who volunteered to participate in clinical trials for a Covid-19 vaccine, has received the attenuated virus and is under close observation at Indian Institute of Medical Sciences and SUM Hospital in Kalinganagar, Odisha. His condition is said to be stable.
Earlier last week, Dhibar received a message from the hospital with a detailed schedule of the trial for Covaxin, which is being jointly developed by Indian Council of Medical Research (ICMR) and Bharat Biotech. The letter mentioned that participation was allowed after a “human subject” was thoroughly screened. Dhibar had applied for Phase I of the trial.
According to ICMR sources, on the first day or Day Zero, a patient normally receives attenuated virus and gets another shot on the 14th day. “Randomised placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine. In these trials, participants are randomised to receive either the vaccine under investigation or a placebo,” an ICMR official said. A placebo is an inert substance such as saline or injection.
Experts say clinical studies carry out initial testing of a vaccine in small numbers of healthy adults. It is normally conducted to test the properties of a vaccine, its tolerability and clinical laboratory and pharmacological parameters.
The Phase I study in a clinical trial is generally concerned with safety. The infective component of the virus will be an antigen and the human body will try to develop an antibody against it. The researchers will then observe whether the antibody can kill the antigen.
Dhibar, who teaches at a primary school in Durgapur, had applied for participation in the clinical trials of the proposed vaccine in April this year. He received a confirmation from ICMR last month after his profile went through a rigorous “exclusion list” check by the apex body for biomedical research. “The last we have heard from the hospital is that Dhibar is keeping well. No communication with him or any volunteer is allowed,” said a friend who did not wish to be named.
Earlier last week, Dhibar received a message from the hospital with a detailed schedule of the trial for Covaxin, which is being jointly developed by Indian Council of Medical Research (ICMR) and Bharat Biotech. The letter mentioned that participation was allowed after a “human subject” was thoroughly screened. Dhibar had applied for Phase I of the trial.
According to ICMR sources, on the first day or Day Zero, a patient normally receives attenuated virus and gets another shot on the 14th day. “Randomised placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine. In these trials, participants are randomised to receive either the vaccine under investigation or a placebo,” an ICMR official said. A placebo is an inert substance such as saline or injection.
Experts say clinical studies carry out initial testing of a vaccine in small numbers of healthy adults. It is normally conducted to test the properties of a vaccine, its tolerability and clinical laboratory and pharmacological parameters.
The Phase I study in a clinical trial is generally concerned with safety. The infective component of the virus will be an antigen and the human body will try to develop an antibody against it. The researchers will then observe whether the antibody can kill the antigen.
Dhibar, who teaches at a primary school in Durgapur, had applied for participation in the clinical trials of the proposed vaccine in April this year. He received a confirmation from ICMR last month after his profile went through a rigorous “exclusion list” check by the apex body for biomedical research. “The last we have heard from the hospital is that Dhibar is keeping well. No communication with him or any volunteer is allowed,” said a friend who did not wish to be named.
