Hyderabad, August 16: India’s indigenous Covaxin maker, Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, on Monday announced that BBV154 (intra nasal vaccine) has? proven to be safe, and well-tolerated? and immunogenic in subjects in controlled clinical trials. 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. BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.
Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, was conducted by Bharat Biotech. The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program. Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India. Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG’s through ELISA’s. To assess vaccine response through the intranasal route, secretory IgA was evaluated by ELISA in serum and saliva.
