作者
Raches Ella, Siddarth Reddy, William Blackwelder, Varsha Potdar, Pragya Yadav, Vamshi Sarangi, Vinay K Aileni, Suman Kanungo, Sanjay Rai, Prabhakar Reddy, Savita Verma, Chandramani Singh, Sagar Redkar, Satyajit Mohapatra, Anil Pandey, Pajanivel Ranganadin, Raghavendra Gumashta, Manish Multani, Shameem Mohammad, Parul Bhatt, Laxmi Kumari, Gajanan Sapkal, Nivedita Gupta, Priya Abraham, Samiran Panda, Sai Prasad, Balram Bhargava, Krishna Ella, Krishna Mohan Vadrevu, P Aggarwal, V Aglawe, A Ali, N Anand, N Awad, V Bafna, G Balasubramaniyam, A Bandkar, P Basha, V Bharge, A Bhate, S Bhate, V Bhavani, R Bhosale, DV Chalapathy, C Chaubal, D Chaudhary, A Chavan, P Desai, D Dhodi, S Dutta, R Garg, K Garg, M George, P Goyal, R Guleria, S Gupta, M Jain, MK Jain, S Jindal, M Kalra, S Kant, P Khosla, P Kulkarni, P Kumar, Y Kumar, A Majumdar, P Meshram, V Mishra, S Mohanty, J Nair, S Pandey, SK Panigrahi, B Patil, V Patil, P Rahate, V Raj, S Ramanand, K Rami, B Ramraj, S Rane, EV Rao, N Rao, R Raphael, G Reddy, V Redkar, S Redkar, A Sachdeva, J Saha, J Sahoo, P Sampath, A Savith, M Shah, L Shanmugam, R Sharma, P Sharma, D Sharma, A Singh, J Singh, P Singh, S Sivaprakasam, S Subramaniam, D Sudheer, S Tandon, M Tariq, V Tripathi, M Vable, R Verma, S Waghmare
发表日期
2021/12/11
期刊
The Lancet
卷号
398
期号
10317
页码范围
2173-2184
出版商
Elsevier
简介
Background
We report the clinical efficacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults.
Methods
We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (stratified for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study-related personnel …
学术搜索中的文章
R Ella, S Reddy, W Blackwelder, V Potdar, P Yadav… - The Lancet, 2021