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Assessment of immunogenicity and protective efficacy of ZyCoV-D DNA vaccine candidates in Rhesus macaques against SARS-CoV-2 infection

Pragya D Yadav, Sanjay Kumar, Kshitij Agarwal, Mukul Jain, Dilip R Patil, Kapil Maithal, Basavaraj Mathapati, Suresh Giri, Sreelekshmy Mohandas, Anita Shete, Gajanan Sapkal, Deepak Y Patil, Ayan Dey, Harish Chandra, Gururaj Deshpande, Nivedita Gupta, Dimpal Nyayanit, Himanshu Kaushal, Rima Sahay, Anuradha Tripathy, Rajlaxmi Jain, Abhimanyu Kumar, Prasad Sarkale, Shreekant Baradkar, Chozhavel Rajanathan, Hari Prasad Raju, Satish Patel, Niraj Shah, Pankaj Dwivedi, Dharmendra Singh, Priya Abraham
doi: https://doi.org/10.1101/2021.02.02.429480
Pragya D Yadav
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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  • For correspondence: hellopragya22@gmail.com
Sanjay Kumar
2Dept of Neurosurgery, Command Hospital (Southern Command), Armed Forces Medical College (AFMC), Pune, India Pin-411040
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Kshitij Agarwal
3Indian Council of Medical Research, Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi, India Pin-110029
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Mukul Jain
4Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Dilip R Patil
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Kapil Maithal
5Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Basavaraj Mathapati
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Suresh Giri
4Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Sreelekshmy Mohandas
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Anita Shete
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Gajanan Sapkal
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Deepak Y Patil
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Ayan Dey
5Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Harish Chandra
5Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Gururaj Deshpande
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Nivedita Gupta
3Indian Council of Medical Research, Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi, India Pin-110029
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Dimpal Nyayanit
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Himanshu Kaushal
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Rima Sahay
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Anuradha Tripathy
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Rajlaxmi Jain
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Abhimanyu Kumar
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Prasad Sarkale
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Shreekant Baradkar
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Chozhavel Rajanathan
5Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Hari Prasad Raju
5Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Satish Patel
4Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Niraj Shah
4Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Pankaj Dwivedi
4Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
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Dharmendra Singh
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Priya Abraham
1Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
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Abstract

Vaccines remain the key protective measure to achieve herd immunity to control the disease burden and stop COVID-19 pandemic. We have developed and assessed the immunogenicity and protective efficacy of two formulations (1mg and 2mg) of ZyCoV-D (a plasmid DNA based vaccine candidates) administered through Needle Free Injection System (NFIS) and syringe-needle (intradermal) in rhesus macaques with three dose vaccine regimens. The vaccine candidate 2mg dose administered using Needle Free Injection System (NFIS) elicited a significant immune response with development of SARS-CoV-2 S1 spike region specific IgG and neutralizing antibody (NAb) titers during the immunization phase and significant enhancement in the levels after the virus challenge. In 2 mg NFIS group the IgG and NAb titers were maintained and showed gradual rise during the immunization period (15 weeks) and till 2 weeks after the virus challenge. It also conferred better protection to macaques evident by the viral clearance from nasal swab, throat swab and bronchoalveolar lavage fluid specimens in comparison with macaques from other immunized groups. In contrast, the animals from placebo group developed high levels of viremia and lung disease following the virus challenge. Besides this, the vaccine candidate also induced increase lymphocyte proliferation and cytokines response (IL-6, IL-5).The administration of the vaccine candidate with NFIS generated a better immunogenicity response in comparison to syringe-needle (intradermal route). The study demonstrated immunogenicity and protective efficacy of the vaccine candidate, ZyCoV-D in rhesus macaques.

Competing Interest Statement

The authors have declared no competing interest.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted February 03, 2021.
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Assessment of immunogenicity and protective efficacy of ZyCoV-D DNA vaccine candidates in Rhesus macaques against SARS-CoV-2 infection
Pragya D Yadav, Sanjay Kumar, Kshitij Agarwal, Mukul Jain, Dilip R Patil, Kapil Maithal, Basavaraj Mathapati, Suresh Giri, Sreelekshmy Mohandas, Anita Shete, Gajanan Sapkal, Deepak Y Patil, Ayan Dey, Harish Chandra, Gururaj Deshpande, Nivedita Gupta, Dimpal Nyayanit, Himanshu Kaushal, Rima Sahay, Anuradha Tripathy, Rajlaxmi Jain, Abhimanyu Kumar, Prasad Sarkale, Shreekant Baradkar, Chozhavel Rajanathan, Hari Prasad Raju, Satish Patel, Niraj Shah, Pankaj Dwivedi, Dharmendra Singh, Priya Abraham
bioRxiv 2021.02.02.429480; doi: https://doi.org/10.1101/2021.02.02.429480
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Assessment of immunogenicity and protective efficacy of ZyCoV-D DNA vaccine candidates in Rhesus macaques against SARS-CoV-2 infection
Pragya D Yadav, Sanjay Kumar, Kshitij Agarwal, Mukul Jain, Dilip R Patil, Kapil Maithal, Basavaraj Mathapati, Suresh Giri, Sreelekshmy Mohandas, Anita Shete, Gajanan Sapkal, Deepak Y Patil, Ayan Dey, Harish Chandra, Gururaj Deshpande, Nivedita Gupta, Dimpal Nyayanit, Himanshu Kaushal, Rima Sahay, Anuradha Tripathy, Rajlaxmi Jain, Abhimanyu Kumar, Prasad Sarkale, Shreekant Baradkar, Chozhavel Rajanathan, Hari Prasad Raju, Satish Patel, Niraj Shah, Pankaj Dwivedi, Dharmendra Singh, Priya Abraham
bioRxiv 2021.02.02.429480; doi: https://doi.org/10.1101/2021.02.02.429480

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