VISAKHAPATNAM: The Visakha Institute of Medical Science has got approval to conduct third phase clinical trials of Covid-19 intranasal vaccine. VIMS is the only institution in the state to get an opportunity to conduct the trials. Being developed by Bharat Biotech, the first and second phase trials have already been completed.
Speaking to TOI, director, VIMS, Dr K Rambabu said this is the first of its kind Covid-19 jab to undergo human clinical trials in India. “We will conduct trials on as many as 3,160 people. While 3,000 people will receive intranasal vaccination, the remaining 160 people will be administered the intramuscular Covaxin. This is to evaluate both safety and immunogenicity,” said Dr Rambabu, who also works as the principal investigator of the trials.
The VIMS director added that the intranasal vaccination will come with several benefits, including creating both systemic and mucosal immunity. “The easy administration, safety, scope for mass vaccination, early completion, etc. are some of the major advantage of the intranasal vaccination. After administration of the vaccine, we will collect 5 ml of blood and 5 ml of saliva from the study subjects to check on IgA, IGM and IgG antibodies. We will complete these trials in the next few months,” said Dr Rambabu.
As per earlier trials, doses of intranasal vaccine administered to volunteers have been well tolerated. No serious adverse events have been reported. 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.
BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech has in-licensed technology from Washington University in St Louis, USA.
Dr P Vijay Kumar would act as the assistant investigator of the trials at VIMS.
