Bharat Biotech International to conduct a phase 1 study of 75 participants to determine the safety and immunogenicity of its chimpanzee adenovirus vector-based intranasal covid-19 vaccine.“After detailed deliberation the committee recommended that, the firm should generate Safety and Immunogenicity data in Phase-I clinical trial (75 subjects) in the proposed doses as per the protocol and submit the data for the consideration of the committee to proceed to Phase II clinical trial," minutes of the SEC meeting that happened last week showed.
The minutes were made public on Monday.Bharat Biotech had submitted animal toxicity, immunogenicity and other data as part of its application to conduct phase 1 and 2 human trials of its experimental.