AIIMS Delhi to start clinical trial of intranasal COVID-19 vaccine from Friday: Sources
Mar 09, 2022
By Shalini Bhardwaj
New Delhi [India], March 9 : All India Institute of Medical Sciences (AIIMS) Delhi will start the clinical trials of Bharat Biotech's intranasal booster dose against COVID-19 from Friday, said sources.
People above 18 years of age, with a vaccination history of more than five months but less than seven months are eligible to participate in the phase 3 trial. The registration will be done either via email or WhatsApp, sources told ANI.
This trial will be heterologous on both, those who have taken two doses of Covaxin or Covishield.
BBV154 is Bharat Biotech's intranasal vaccine. The Drugs Controller General of India (DCGI) had granted permission to the Hyderabad-based pharmaceutical company to conduct clinical trials of intranasal booster vaccine dose in the country in January 2021.
The NOC letter by DCGI reads: "Central Licensing Authority hereby permits Bharat Biotech International limited to conduct clinical trials of the new drug or investigational new drug."
The dosage form of the vaccine is liquid for the intranasal route of administration and every single dose contains 0.5ml. The trials of the intranasal vaccine will take place at nine different sites of the country.
The trials will be conducted at different sites including Atman Hospital, Ahmedabad, Gujarat, AIIMS, Delhi and Patna, Oyster and Pearls Hospitals, Pune, Pt. BD Sharma Postgraduate Institute of Medical Sciences at Rohtak, Haryana, Acharya Vinobha Bhave Rural Hospital, Wardha, Jeevan Rekha Hospital, Belagavi, Rana Hospital, Gorakhpur, Prakhar Hospital, Uttar Pradesh.
