Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques

Pragya D. Yadav, Raches Ella, Sanjay Kumar, Dilip R. Patil, Sreelekshmy Mohandas, Anita M. Shete, Krishna M. Vadrevu, Gaurav Bhati, Gajanan Sapkal, Himanshu Kaushal, Savita Patil, Rajlaxmi Jain, Gururaj Deshpande, Nivedita Gupta, Kshitij Agarwal, Mangesh Gokhale, Basavaraj Mathapati, Siddhanath Metkari, Chandrashekhar Mote, Dimpal Nyayanit, Deepak Y. Patil, B. S. Sai Prasad, Annasaheb Suryawanshi, Manoj Kadam, Abhimanyu Kumar, Sachin Daigude, Sanjay Gopale, Triparna Majumdar, Deepak Mali, Prasad Sarkale, Shreekant Baradkar, Pranita Gawande, Yash Joshi, Sidharam Fulari, Hitesh Dighe, Sharda Sharma, Rashmi Gunjikar, Abhinendra Kumar, Kaumudi Kalele, Vellimedu K. Srinivas, Raman R. Gangakhedkar, Krishna M. Ella, Priya Abraham, Samiran Panda and Balram Bhargava ()
Additional contact information
Pragya D. Yadav: Indian Council of Medical Research-National Institute of Virology
Raches Ella: Bharat Biotech International Limited, Genome Valley
Sanjay Kumar: Department of Neurosurgery, Command Hospital (Southern Command), Armed Forces Medical College (AFMC)
Dilip R. Patil: Indian Council of Medical Research-National Institute of Virology
Sreelekshmy Mohandas: Indian Council of Medical Research-National Institute of Virology
Anita M. Shete: Indian Council of Medical Research-National Institute of Virology
Krishna M. Vadrevu: Bharat Biotech International Limited, Genome Valley
Gaurav Bhati: Army Institute of Cardio-Thoracic Sciences
Gajanan Sapkal: Indian Council of Medical Research-National Institute of Virology
Himanshu Kaushal: Indian Council of Medical Research-National Institute of Virology
Savita Patil: Indian Council of Medical Research-National Institute of Virology
Rajlaxmi Jain: Indian Council of Medical Research-National Institute of Virology
Gururaj Deshpande: Indian Council of Medical Research-National Institute of Virology
Nivedita Gupta: Indian Council of Medical Research, V. Ramalingaswami Bhawan
Kshitij Agarwal: Indian Council of Medical Research, V. Ramalingaswami Bhawan
Mangesh Gokhale: Indian Council of Medical Research-National Institute of Virology
Basavaraj Mathapati: Indian Council of Medical Research-National Institute of Virology
Siddhanath Metkari: ICMR-National Institute for Research in Reproductive Health
Chandrashekhar Mote: Department of Veterinary Pathology, Krantisinh Nana Patil College of Veterinary Science
Dimpal Nyayanit: Indian Council of Medical Research-National Institute of Virology
Deepak Y. Patil: Indian Council of Medical Research-National Institute of Virology
B. S. Sai Prasad: Bharat Biotech International Limited, Genome Valley
Annasaheb Suryawanshi: Indian Council of Medical Research-National Institute of Virology
Manoj Kadam: Indian Council of Medical Research-National Institute of Virology
Abhimanyu Kumar: Indian Council of Medical Research-National Institute of Virology
Sachin Daigude: Indian Council of Medical Research-National Institute of Virology
Sanjay Gopale: Indian Council of Medical Research-National Institute of Virology
Triparna Majumdar: Indian Council of Medical Research-National Institute of Virology
Deepak Mali: Indian Council of Medical Research-National Institute of Virology
Prasad Sarkale: Indian Council of Medical Research-National Institute of Virology
Shreekant Baradkar: Indian Council of Medical Research-National Institute of Virology
Pranita Gawande: Indian Council of Medical Research-National Institute of Virology
Yash Joshi: Indian Council of Medical Research-National Institute of Virology
Sidharam Fulari: Indian Council of Medical Research-National Institute of Virology
Hitesh Dighe: Indian Council of Medical Research-National Institute of Virology
Sharda Sharma: Indian Council of Medical Research-National Institute of Virology
Rashmi Gunjikar: Indian Council of Medical Research-National Institute of Virology
Abhinendra Kumar: Indian Council of Medical Research-National Institute of Virology
Kaumudi Kalele: Indian Council of Medical Research-National Institute of Virology
Vellimedu K. Srinivas: Bharat Biotech International Limited, Genome Valley
Raman R. Gangakhedkar: Indian Council of Medical Research, V. Ramalingaswami Bhawan
Krishna M. Ella: Bharat Biotech International Limited, Genome Valley
Priya Abraham: Indian Council of Medical Research-National Institute of Virology
Samiran Panda: Indian Council of Medical Research, V. Ramalingaswami Bhawan
Balram Bhargava: Indian Council of Medical Research, V. Ramalingaswami Bhawan

Nature Communications, 2021, vol. 12, issue 1, 1-11

Abstract: Abstract The COVID-19 pandemic is a global health crisis that poses a great challenge to the public health system of affected countries. Safe and effective vaccines are needed to overcome this crisis. Here, we develop and assess the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine in rhesus macaques. Twenty macaques were divided into four groups of five animals each. One group was administered a placebo, while three groups were immunized with three different vaccine candidates of BBV152 at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 fourteen days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd-week post-immunization. Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which exhibited interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry. This vaccine candidate BBV152 has completed Phase I/II (NCT04471519) clinical trials in India and is presently in phase III, data of this study substantiates the immunogenicity and protective efficacy of the vaccine candidates.

Date: 2021
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DOI: 10.1038/s41467-021-21639-w

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