The Company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on 15th July 2020, has been well tolerated. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies.
The 7 day safety of the vaccine in all the subjects enrolled in the Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial. The Phase I study of ZyCoV-D will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose escalation, multicentric, randomized, double-blind placebo controlled study. The phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate in line with the current global clinical trial protocols in general. The neutralization potential of the antibodies elicited by the vaccine would also be checked by virus neutralization assay. The durability of the humoral response up to 6 months post last dose will also be evaluated.
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