New Delhi, Aug 15 (Prensa Latina) Bharat Biotech International Limited (BBIL) on Monday announced that its intra-nasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
According to the company, BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. “This vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results. BBV154 has been specifically formulated to allow intranasal delivery.
In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries,” the company said in a statement on Monday.
BBV154 was developed in collaboration with the University of Washington, which designed and developed the recombinant adenoviral vector constructs and evaluated them in preclinical trials for efficacy.
Bharat Biotech conducted the preclinical safety assessment, manufacturing scale-up, formulation and delivery device development, including human clinical trials.
The Indian government partially funded the product development and clinical trials through a Department of Biotechnology program, while Phase III trials were conducted at 14 national centers.