CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters

Rapid development of coronavirus disease 2019 (COVID-19) vaccines and antiviral drugs have significantly reduced morbidity and mortality worldwide. Although most of the vaccines were developed initially with the ancestral Wuhan antigen, here, we report the development and immunological efficacy of a...

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Main Authors: Jyotsna Dandotiya, Neeta Adhikari, Manas Ranjan Tripathy, Kamini Jakhar, Sudipta Sonar, Dibya Ranjan Pati, Vibhu Kanchan, Varsha S. Prasad, Jitendra Kumar, Nitesh K. Senapati, Arti Bharmoria, Neeraj Rani, Monika Lakhanpal, CS. Patil, Nishan Singh, Lovely Khan, Lavit Jambu, Naveen K. Jain, Syed Khalid Ali, Priyanka Priyadarsiny, Amulya K. Panda, Rajesh Jain, Shailendra Mani, Sweety Samal, Amit Awasthi, Zaigham Abbas Rizvi
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Immunology
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Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2024.1447962/full
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author Jyotsna Dandotiya
Neeta Adhikari
Manas Ranjan Tripathy
Manas Ranjan Tripathy
Kamini Jakhar
Sudipta Sonar
Dibya Ranjan Pati
Vibhu Kanchan
Varsha S. Prasad
Jitendra Kumar
Nitesh K. Senapati
Arti Bharmoria
Neeraj Rani
Monika Lakhanpal
CS. Patil
Nishan Singh
Lovely Khan
Lavit Jambu
Naveen K. Jain
Syed Khalid Ali
Priyanka Priyadarsiny
Amulya K. Panda
Rajesh Jain
Shailendra Mani
Sweety Samal
Amit Awasthi
Amit Awasthi
Zaigham Abbas Rizvi
Zaigham Abbas Rizvi
author_facet Jyotsna Dandotiya
Neeta Adhikari
Manas Ranjan Tripathy
Manas Ranjan Tripathy
Kamini Jakhar
Sudipta Sonar
Dibya Ranjan Pati
Vibhu Kanchan
Varsha S. Prasad
Jitendra Kumar
Nitesh K. Senapati
Arti Bharmoria
Neeraj Rani
Monika Lakhanpal
CS. Patil
Nishan Singh
Lovely Khan
Lavit Jambu
Naveen K. Jain
Syed Khalid Ali
Priyanka Priyadarsiny
Amulya K. Panda
Rajesh Jain
Shailendra Mani
Sweety Samal
Amit Awasthi
Amit Awasthi
Zaigham Abbas Rizvi
Zaigham Abbas Rizvi
author_sort Jyotsna Dandotiya
collection DOAJ
description Rapid development of coronavirus disease 2019 (COVID-19) vaccines and antiviral drugs have significantly reduced morbidity and mortality worldwide. Although most of the vaccines were developed initially with the ancestral Wuhan antigen, here, we report the development and immunological efficacy of a whole-virion–inactivated vaccine candidate (CoviWall) to combat the deadly B.1.617.2 (Delta strain) infection. In the current study, we demonstrate a consistent manufacturing process under Good Manufacturing Practice for the development of CoviWall and its characterization using various analytical methods as per regulatory compliance. In addition, we provide pre-clinical immunogenicity and protective efficacy data of the CoviWall vaccine. All the three test doses (i.e., low dose, mid dose, and high dose) immunized in C57BL/6 mice elicited a high titer of anti–receptor-binding domain antibody and neutralizing antibody response against severe acute respiratory syndrome coronavirus–2 (SARS-CoV-2) after second booster dose. In addition, CoviWall immunization also produced a significant T-cell response in the immunized animals. Our B.1.617.2 strain challenge data in Syrian hamsters indicate that immunized hamsters show attenuated clinical manifestations of COVID-19 with reduced lung viral load. Moreover, assessment of pulmonary histopathology revealed lower cellular injury, inflammation, and pneumonia in the vaccinated hamsters as compared to the unvaccinated animals. Such promising results augur well for the clinical phase I trial of the CoviWall vaccine and further development against contagious SARS-CoV-2 strains in the future.
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spelling doaj-art-156fd1dc915a4158a1eeba37e50fb99c2025-01-22T07:12:55ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-01-011510.3389/fimmu.2024.14479621447962CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamstersJyotsna Dandotiya0Neeta Adhikari1Manas Ranjan Tripathy2Manas Ranjan Tripathy3Kamini Jakhar4Sudipta Sonar5Dibya Ranjan Pati6Vibhu Kanchan7Varsha S. Prasad8Jitendra Kumar9Nitesh K. Senapati10Arti Bharmoria11Neeraj Rani12Monika Lakhanpal13CS. Patil14Nishan Singh15Lovely Khan16Lavit Jambu17Naveen K. Jain18Syed Khalid Ali19Priyanka Priyadarsiny20Amulya K. Panda21Rajesh Jain22Shailendra Mani23Sweety Samal24Amit Awasthi25Amit Awasthi26Zaigham Abbas Rizvi27Zaigham Abbas Rizvi28Immuno-biology Lab, Centre for Immunobiology and Immunotherapy, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmuno-biology Lab, Centre for Immunobiology and Immunotherapy, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmuno-biology Lab, Centre for Immunobiology and Immunotherapy, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmunology-Core Lab, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaOneStream Research Centre, Panacea Biotec Limited, New Delhi, IndiaOneStream Research Centre, Panacea Biotec Limited, New Delhi, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaTranslational Health Science & Technology Institute (THSTI), NCR-Biotech Science Cluster, Faridabad, Haryana, IndiaOneStream Research Centre, Panacea Biotec Limited, New Delhi, IndiaOneStream Research Centre, Panacea Biotec Limited, New Delhi, IndiaImmuno-biology Lab, Centre for Immunobiology and Immunotherapy, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmunology-Core Lab, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmuno-biology Lab, Centre for Immunobiology and Immunotherapy, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaImmunology-Core Lab, Translational Health Science and Technology Institute, Near Capital Region (NCR)-Biotech Science Cluster, Faridabad, Haryana, IndiaRapid development of coronavirus disease 2019 (COVID-19) vaccines and antiviral drugs have significantly reduced morbidity and mortality worldwide. Although most of the vaccines were developed initially with the ancestral Wuhan antigen, here, we report the development and immunological efficacy of a whole-virion–inactivated vaccine candidate (CoviWall) to combat the deadly B.1.617.2 (Delta strain) infection. In the current study, we demonstrate a consistent manufacturing process under Good Manufacturing Practice for the development of CoviWall and its characterization using various analytical methods as per regulatory compliance. In addition, we provide pre-clinical immunogenicity and protective efficacy data of the CoviWall vaccine. All the three test doses (i.e., low dose, mid dose, and high dose) immunized in C57BL/6 mice elicited a high titer of anti–receptor-binding domain antibody and neutralizing antibody response against severe acute respiratory syndrome coronavirus–2 (SARS-CoV-2) after second booster dose. In addition, CoviWall immunization also produced a significant T-cell response in the immunized animals. Our B.1.617.2 strain challenge data in Syrian hamsters indicate that immunized hamsters show attenuated clinical manifestations of COVID-19 with reduced lung viral load. Moreover, assessment of pulmonary histopathology revealed lower cellular injury, inflammation, and pneumonia in the vaccinated hamsters as compared to the unvaccinated animals. Such promising results augur well for the clinical phase I trial of the CoviWall vaccine and further development against contagious SARS-CoV-2 strains in the future.https://www.frontiersin.org/articles/10.3389/fimmu.2024.1447962/fullCoviWallCOVID-19-vaccineimmunogenicityhamsterDelta strainTh1
spellingShingle Jyotsna Dandotiya
Neeta Adhikari
Manas Ranjan Tripathy
Manas Ranjan Tripathy
Kamini Jakhar
Sudipta Sonar
Dibya Ranjan Pati
Vibhu Kanchan
Varsha S. Prasad
Jitendra Kumar
Nitesh K. Senapati
Arti Bharmoria
Neeraj Rani
Monika Lakhanpal
CS. Patil
Nishan Singh
Lovely Khan
Lavit Jambu
Naveen K. Jain
Syed Khalid Ali
Priyanka Priyadarsiny
Amulya K. Panda
Rajesh Jain
Shailendra Mani
Sweety Samal
Amit Awasthi
Amit Awasthi
Zaigham Abbas Rizvi
Zaigham Abbas Rizvi
CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
Frontiers in Immunology
CoviWall
COVID-19-vaccine
immunogenicity
hamster
Delta strain
Th1
title CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
title_full CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
title_fullStr CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
title_full_unstemmed CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
title_short CoviWall, a whole-virion-inactivated B.1.617.2 vaccine candidate, induces potent humoral and Th1 cell response in mice and protects against B.1.617.2 strain challenge in Syrian hamsters
title_sort coviwall a whole virion inactivated b 1 617 2 vaccine candidate induces potent humoral and th1 cell response in mice and protects against b 1 617 2 strain challenge in syrian hamsters
topic CoviWall
COVID-19-vaccine
immunogenicity
hamster
Delta strain
Th1
url https://www.frontiersin.org/articles/10.3389/fimmu.2024.1447962/full
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