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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 Yadav; Sanjay Kumar; Kshitij Agarwal; Mukul Jain; Dilip Patil; Kapil Maithal; Basavaraj Mathapati; Suresh Giri; Sreelekshmy Mohandas; Anita Shete; Gajanan Sapkal; Deepak 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.
  • Pragya Yadav; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Sanjay Kumar; Dept of Neurosurgery, Command Hospital (Southern Command), Armed Forces Medical College (AFMC), Pune, India Pin- 411040
  • Kshitij Agarwal; Indian Council of Medical Research, Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi, India Pin-110029
  • Mukul Jain; Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Dilip Patil; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Kapil Maithal; Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Basavaraj Mathapati; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Suresh Giri; Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Sreelekshmy Mohandas; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Anita Shete; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Gajanan Sapkal; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Deepak Patil; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Ayan Dey; Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Harish Chandra; Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Gururaj Deshpande; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Nivedita Gupta; Indian Council of Medical Research, Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi, India Pin-110029
  • Dimpal Nyayanit; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Himanshu Kaushal; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Rima Sahay; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Anuradha Tripathy; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Rajlaxmi Jain; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Abhimanyu Kumar; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Prasad Sarkale; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Shreekant Baradkar; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Chozhavel Rajanathan; Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Hari Prasad Raju; Vaccine Technology Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Satish Patel; Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Niraj Shah; Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Pankaj Dwivedi; Zydus Research Centre, Cadila Healthcare Limited, Ahmedabad, Gujarat, India Pin-382481
  • Dharmendra Singh; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
  • Priya Abraham; Indian Council of Medical Research-National Institute of Virology, Pune, Maharashtra, India Pin-411021
Preprint En | PREPRINT-BIORXIV | ID: ppbiorxiv-429480
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.
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