For the first time, the Brihanmumbai Municipal Corporation (BMC) has started clinical trials of the ZyCoV-D vaccine on children at the BYL Nair hospital.
This is the first civic-run hospital that is conducting clinical trials on children between the age group of 12 and 18 years. The civic officials said the hospital has enrolled 50 children for the trial after the ethics committee of a hospital gave the green signal.
Zydus Cadila Healthcare is conducting trials across 59 sites for children aged between 12 and 18 and adults aged up to 65 for ZyCoV-D. Of them, 14 sites are in Maharashtra.
Dr Ramesh Bharmal, dean, Nair Hospital, said they have enrolled a total of 50 children and three shots of ZyCoV-2 vaccine will be given in a trial on an equal interval. For which they have made all arrangements and enrolling children based on a criteria set by the ethics committee.
“We have been waiting for the approval which we received last week from the ethics committee. All the participants are being thoroughly checked and they are not allowed to take any Covid-19 vaccines until the trial is not completed,” said Dr Bharmal.
He further said that of the total 50 participants, 25 will be given placebo and remaining 25 will be given ZyCoV-D. Moreover, to demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.
“The duration of the trial is one year in which we will be evaluating persistence of immunogenicity at 56, 84, 168, 252 and 364 days after first dose of ZyCoV-D. Moreover we will also evaluate safety and tolerability of ZyCoV-D,” added Dr Bharmal.
Criteria for clinical trial
1. Healthy subject of either gender ≥12 years of age.
2. Not to take any Covid-19 licensed vaccination for the entire duration of the study.
3. Ability to provide informed consent from the adult subjects or from the parents of paediatric
subjects. Assent from paediatric subjects (Audio video recording in case of vulnerable
subject).
4. Adult subjects or parents of paediatric subjects literate enough to fill the diary card.
5. Subjects with good health or with stable medical conditions for chronic disease.
6. Females of childbearing potential, must agree to use one of the approved contraception use contraception.
7. Willing to allow storage and future use of biological samples for future research.
