Hyderabad-based Biological E’s Corbevax vaccine clinical trial study in children has 624 children aged 5 years to 18 years, according to the Clinical Trial Registry of India at ten trial sites across the country.
Among the ten trial sites, three are in Karnataka - one in Belagavi and two in Mysuru.
Corbevax will be administered to 12- to 14-year-olds from Wednesday. The state has a target of 20 lakh kids in this age group.
The three trial sites in Karnataka are Cheluvamba Hospital attached to Mysore Medical College and Research Institute, JSS Medical College and Hospital in Mysuru, and KLES Dr Prabhakar Kore Hospital and Medical Research Centre in Belagavi.
Principal Investigator Dr Pradeep N of the Department of Paediatrics, Cheluvamba Hospital, told DH, “From our site, 63 subjects were eligible. Most are 10 to 13 years old. They received the second dose two months ago and as a part of the trial, will be administered the booster dose after a six months gap in July if their antibody titers are less”.
Thirty-five of them are girls and 28 are boys. Except for mild fever and pain at the injection site, no untoward complications happened in these kids.
“We are still in contact with them. It was very difficult to find kids with no prior infection. We screened 300 subjects and found only 63 to be eligible. As many as 130 tested Covid antibody-positive suggesting past infection,” he said.
Principal Investigator Dr Niranjana S Mahantshetti of the Department of Paediatrics, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi, said, “We have not completed the trial yet. So far, we have had no problems in terms of side effects. We don’t know about the immunogenicity or the antibody levels yet. We have 55 subjects, out of which 24 completed both doses. Most kids already had Covid antibodies and such children can’t be part of the trial.”
Principal Investigator Dr Mandyam Dhati Ravi, Department of Paediatrics, JSS Medical College and Hospital, Mysuru, told DH, “As far as I know the vaccine is safe. But we don’t have data from the study since it is not over yet at the ten trial sites. There were no adverse events at our site.”
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