After being one of the few worthy vaccine candidates, Hyderabad based Bharat Biotech has made its next big move by entering as intranasal vaccine into the Phase 1 of human clinical trials. Though it would be quicker and also easier to administer, we will have to wait and weigh if it poses any adverse reactions to the administered person. If not, it would be a great way to quickly tackle the increasing numbers.
Bharat Biotech has codenamed it’s intranasal vaccine as BBV154, and have commenced its human clinical trials at some of the selected sites that include Hyderabad and Nagpur. The trials of the chimpanzee adenovirus vectored vaccine candidate, being developed in collaboration with the Washington University School of Medicine at St Louis (WashU), are to be conducted on 175 healthy volunteers aged between 18-60 years at four sites – Hyderabad, Nagpur, Patna and Chennai.
Apart from the Hyderabad hospital, the Gillurkar Multispeciality hospital at Nagpur, All India Institute of Medical Sciences (AIIMS) at Patna and the Apollo Specialty Hospital at Chennai will be conducting the vaccine trials, as per the CTRI (Clinical Trials Registry-India) website. While the institutional ethics committees of the Hyderabad, Nagpur and Patna hospitals have already approved the trials, the Chennai hospital is still awaiting the ethics committee nod. As part of the randomised, double-blinded trial to evaluate the reactogenicity, safety and immunogenicity of the vaccine candidate, the volunteers will be divided into three groups. In the first group, 70 volunteers will be administered a single dose of the vaccine followed by a placebo after 28 days. In the second group 70 volunteers will be given two doses of the vaccine 28 days apart and in the third group 35 volunteers will get two doses of the placebo (a substance that has no therapeutic value).
The company will conduct an interim analysis on day 42 after the administration of the first dose to ascertain the vaccine’s immunogenicity and safety before submitting the data to the CDSCO (Central Drugs Standard Control Organisation). Bharat Biotech plans to produce 1 billion doses of the non-invasive, vaccine, which is being touted as a game-changer as it will not only be quicker but also easier to administer.
