In controlled clinical trials for the Covid vaccine BBV154 as a primary and as a heterologous booster, Bharat Biotech International Limited (BBIL) said today, its intranasal Covid-19 vaccine BBV154 has demonstrated to be safe, well-tolerated, and immunogenic in subjects. BBIL has submitted the data from both the Phase III trials for approval to India’s regulatory authorities.
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.
Highlights BBV154 intranasal Covid vaccine clinical development
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.
Data from both Phase III human clinical trials have been submitted for approval to National Regulatory Authorities.
Primary dose schedule phase III trials were conducted for safety, and immunogenicity in ~3100 subjects, and compared with COVAXIN. The trials were conducted in 14 trial sites across 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’s were evaluated by ELISA in serum and saliva. Evaluation was also carried out for the ability of BBV154 to elicit long term memory T and B cell responses against the ancestral and omicron variants,” Bharat Biotech said.
“Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission. Further studies are being planned,” the company said.
BBIL had conducted two separate and simultaneous clinical trials to evaluate BBV154, which is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein, as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who had received two doses of the two commonly administered Covid-19 vaccines in India.
While the primary dose schedule Phase III trials were conducted for safety, and immunogenicity in around 3,100 subjects at 14 trial sites across India and compared with its whole virus vaccine Covaxin, the heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects at 9 trial sites in India where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed Covid-19 vaccines.