Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial

• Published in: The Lancet (British edition) Vol. 398; no. 10317; pp. 2173 - 2184
• Main Authors: Ella, Raches, Reddy, Siddarth, Blackwelder, William, Potdar, Varsha, Yadav, Pragya, Sarangi, Vamshi, Aileni, Vinay K, Rai, Sanjay, Reddy, Prabhakar, Verma, Savita, Singh, Chandramani, Redkar, Sagar, Mohapatra, Satyajit, Pandey, Anil, Ranganadin, Pajanivel, Gumashta, Raghavendra, Multani, Manish, Mohammad, Shameem, Bhatt, Parul, Kumari, Laxmi, Sapkal, Gajanan, Gupta, Nivedita, Abraham, Priya, Panda, Samiran, Prasad, Sai, Bhargava, Balram, Ella, Krishna, Vadrevu, Krishna Mohan, Aggarwal, P., Aglawe, V., Ali, A., Anand, N., Awad, N., Bafna, V., Balasubramaniyam, G., Bandkar, A., Basha, P., Bharge, V., Bhate, A., Bhate, S., Bhavani, V., Bhosale, R., Chalapathy, DV, Chaubal, C., Desai, P., Dhodi, D., Dutta, S., Garg, R., Garg, K., George, M., Goyal, P., Guleria, R., Jain, M., Jain, M.K., Jindal, S., Kalra, M., Kant, S., Khosla, P., Kumar, P., Kumar, Y., Majumdar, A., Meshram, P., Mishra, V., Mohanty, S., Nair, J., Pandey, S., Patil, B., Patil, V., Rahate, P., Raj, V., Ramanand, S., Rami, K., Ramraj, B., Rane, S., Rao, E.V., Rao, N., Raphael, R., Reddy, G., Redkar, V., Redkar, S., Sachdeva, A., Saha, J., Sahoo, J., Sampath, P., Savith, A., Shah, M., Shanmugam, L., Sharma, R., Sharma, P., Sharma, D., Singh, J., Singh, P., Sivaprakasam, S., Subramaniam, S., Sudheer, D., Tandon, S., Tripathi, V., Vable, M., Verma, R., Waghmare, S.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 11.12.2021; Elsevier Limited
• Subjects: Adjudication; Adjuvants, Immunologic; Adult; Adults; Adverse events; Anaphylaxis; Antigens; Asymptomatic; Chronic conditions; Chronic illnesses; Clinical significance; Clinical trials; Committees; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 Nucleic Acid Testing; COVID-19 vaccines; COVID-19 Vaccines - immunology; Deactivation; Dosage; Double-Blind Method; Double-blind studies; Female; Health services; Humans; Immunization; Immunogenicity; Immunogenicity, Vaccine; Immunology; Immunosuppressive agents; India; Male; Medical research; Pandemics; Placebos; Polymerase chain reaction; Population studies; Proteins; Randomization; Safety; Severe acute respiratory syndrome coronavirus 2; Toll-like receptors; Vaccine Efficacy; Vaccines; Vaccines, Inactivated - immunology; Viral diseases; Virions; India

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. We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 cl...