Bharat Biotech is set to carry out a study to assess the level of protection given by the mix and match of Covaxin, an intranasal vaccine along with Covishield in five different ways on more than 800 participants, News18.com has learnt.
The company plans to conduct the trial at nine sites across the country to study the immunogenic response induced by a different combination of three vaccines.
While Covaxin and Serum Institute of India’s Covishield are already being used in India’s vaccination drive against Covid-19, BBV154 intranasal vaccine is Bharat Biotech’s novel adenovirus vectored vaccine, which is needle-free and likely to prevent Covid-19 infection as well.
The objective of the trial — titled as ‘Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines’ — is to understand the best combination of heterologous boosting.
The purpose of the study is to evaluate the immunogenicity and safety of three vaccines when administered as a booster dose in individuals previously vaccinated in India.
Post two months of vaccination, an interim report will be notified to the Central Drugs Standard Control Organization (CDSCO).
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Details of the Trial
A total sample size of 875 healthy volunteers over 18 years of age will be recruited in this study in the ratio of 2:1:2:1:1.
In Group 1, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with Covaxin.
In group 2 — 125 participants will be given a booster dose of Covaxin vaccine, in individuals previously vaccinated with Covaxin.
In Group 3, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with Covishield.
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In Group 4, 125 participants will be recruited and administered with a booster dose of Covaxin, in individuals previously vaccinated with Covishield.
In Group 5, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with Covishield.
The study duration is of six months after the vaccine is administered.
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