Maximum Containment Laboratory

• 1. Provide diagnostic for referred samples for viral hemorrhagic fever & unknown etiology and outbreak investigation [Service project]

  2. Testing & rectification of different components of BSL-4 Facility and preparation of basic documents [Service project]

  3. Surveillance for Zika virus infection in humans, India [Extramural project]

  4. Sustainable Laboratory Network for Monitoring of Hemorrhagic Fever viruses and mitigation of high risk pathogen [Extramural project]

  5. Countrywide survey of Nipah virus in Pteropus bats [Extramural project]

  6. Reinfection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS CoV-2) among healthcare workers in India [Extramural project]

  7. Development and dissemination of serological assays for priority pathogens [Extramural project]

  8. Immune response to precautionary third dose of COVISHIELD/COVAXIN among healthy adult population: an ICMR Cohort study, India [Extramural project]

  9. Assessment of prophylactic and therapeutic role of BCG vaccine against SARS-CoV-2 infection in hamster model [Extramural project]

  10. Identification and characterization of novel viral isolates using Next-generation sequencing platform [Intramural project]

  11. Molecular epidemiological analysis of SARS-CoV-2 circulating in different regions of India [Intramural project]

  12. Countrywide survey of Nipah virus and Corona virus in different species of bats [Intramural project]

  13. A Study On Pathogenicity Of Nipah Virus (Kerala Isolate) In Syrian Hamster Model [Intramural project]

  14. A prospective observational study to establish the duration of persistence of replication-competent SARS-CoV-2 in oncology patients with COVID-19 on chemotherapy [Intramural project]

  15. Propagation of new SARS-CoV-2 variant isolate and characterization in cell culture and animal model [Intramural project]

  16. Comparative assessment of BBV152 vaccine (COVAXIN™) antibody and antigen-specific responses in immunized population without past COVID-19 infection, individuals vaccinated after recovery from COVID-19 and non-vaccinated individuals with past COVID-19 infection [Intramural project]

  17. Assessment of immunological responses in breakthrough cases of SARS-CoV-2 in post COVID-19 vaccinated group [Intramural project]

  18. Metagenomic analysis of viral pathogens from bats and ticks collected from various parts of India [Intramural project]

  19. Characterization of hACE2 mice as an animal model for SARS-CoV-2 infection [Intramural project]

  20. Evaluation of immunogenicity and protective efficacy after vaccine Interchangeability in a selected population of Eastern UP [Intramural project]

Quality Assurance in laboratory testing for better surveillance

               Maximum Containment Facility the nodal institute established laboratory quality system for the CCHF and KFD diagnosis and National Accreditation Board for Testing and Calibration Laboratories (NABL) (ISO/IEC 17025:2005) was implemented to provide the quality and technical competence of CCHF and KFD molecular and serological diagnostic tests since 2016.

Significant research findings/contributions in last ten years

1. Outbreak detection, Containment response and preparedness

• Crimean Congo hemorrhagic fever (CCHF) outbreaks in Gujarat (2011-2022) & Rajasthan (2014, 2015 and 2019)
• Kyasanur forest disease (KFD) outbreaks in Karnataka, Kerala, Maharashtra, Goa & Tamil Nadu
• Nipah outbreaks in Kerala in 2018, 2019 and 2021
• Zika outbreaks in Gujarat (2017), Rajasthan (2018), Madhya Pradesh (2018), Uttar Pradesh (2021), & Kerala (2021).
• Emergency preparedness for Ebola , Yellow fever virus and Monkeypox virus.

2. Detection of novel viruses

• Malsoor, Tioman, Adenovirus & Beta coronavirus from bats
• Oya, Cat Que, Balagodu & Kammavanpettai virus from birds
• Quaranfil, Kaisodi, Wad Medani & Coltivirus (Kundal) from ticks
• Canine Distemper virus from tiger
• Equine encepholosis virus from horse
• Mason Pfizer virus from monkey

3. One Health based research

• Bat survey for Nipah
• Tick survey for CCHF, KFD & Kaisodi
• Livestock survey for CCHF, RVF
• Human survey for CCHF, KFD, Nipah, Malsoor, Cat Que, Zika, SARS-CoV-2
• Pathogenesis studies in mice & hamsters for KFD, CCHF, Nipah, Zika & SARS-CoV-2
• Vector susceptibility studied on Zika, Yellow fever & Cat que

4. Translational Research

    

• Isolation & characterization of CCHF, KFD, Nipah, SARS-CoV-2 variants & other emerging and re-emerging viruses
• CCHF IgM/IgG ELISA for human, cattle & sheep
• Nipah IgM/IgG ELISA for human, bat & pig
• KFD IgM/IgG ELISA for human
• Point of care test for Nipah & KFD
• SARS-CoV-2 IgG ELISA for human

5. Vaccine efficacy & Therapeutic Research

• PLACID trial to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications in moderate disease
• Antiviral studies for SARS-CoV-2
• Development of first indigenous inactivated COVID-19 vaccine (Covaxin) in collaboration with Bharat Biotech International Limited, Hyderabad
• Preclinical studies of Covaxin in Rhesus macaques and Syrian hamsters
• Laboratory support in Phase I, II, III clinical trials of Covaxin
• Isolation and Neutralization studies with SARS-CoV-2 Variants of Concern (Alpha, Beta, Delta, Omicron)

6. Bio-risk mitigation training:

• As a part of WHO-CC for remerging and re-merging infection, BSL-4 facility always extended the training support to SEAR countries including Bhutan, Sri-Lanka, Myanmar, Bangladesh, Indonesia, Nepal, Maldives and Thailand in many bilateral programs.
• The training and sensitization workshop included in-depth details on bio-safety, bio-security, and management of the bio-risk program while working in the BSL-2 and BSL-3 laboratory.
• ICMR-NIV, Pune played a pivotal role in trainings for the engineering aspects and its role in the containment facility.
• More than 100 onsite and off sites training were conducted for the Bio-risk mitigation for the emerging and re-emerging viruses including Ebola, Marburg, Lassa Fever, Yellow Fever, Nipah,. CCHF, KFDV, for the VRDL network by BSL-4 team.

7. Establishment of Viral Hemorrhagic Fever Surveillance network in India:

• Under Global Health Security Agenda, ICMR-NIV, Pune implemented many activities for enhancing awareness under ‘One Health’ program from September 2015 and established six VHF diagnostic laboratories in county.
• It included Sher-i-Kashmir Institute of Medical Sciences, Srinagar; King George’s Medical University, Lucknow; Sawai Man Singh Medical College, Jaipur; ICMR-National Institute of Research in Tribal Health, Jabalpur; ICMR-Regional Medical Research Center, Bhubaneswar and ICMR-Regional Medical Research Center, Port Blair.
• On the similar lines 10 KFDV laboratory network in the Western Ghats of India and 7 CCHF network strengthening activities are going on in the country.

8. Preparedness for emerging/Re-emerging viruses in India including Ebola and Yellow Fever:

• Ebola threat griped India and ICMR-NIV, Pune has taken the lead to trained 13 laboratories for Ebola diagnosis in India.
• One Ebola recovered case [resident of India, returned from affected country] was followed for persistence of virus in semen and data showed persistence of viral RNA for 165 days.
• Yellow fever emergency and alert by the ministry of health demanded the preparedness for laboratory diagnosis of Yellow fever.
• Under the aegis of GHS division of ICMR, ICMR-NIV, ICMR-NIE, ICMR-NARI and WHO, a capacity-building programme under IPPP was initiated in 2022 with the aim to provide healthcare systems and communities with an understanding of how they can prepare for and respond to a future pandemic through a practical, inter-sectoral and interdisciplinary approach.

9. Preparedness for the Monkeypox virus threat in India

• National Guidelines on Monkeypox virus was published under the aegis of MoHFW, ICMR-NIV Pune, NCDC in May 2022. Guidelines for sample collection and shipment were made and circulated to WHO SEAR countries.
• For capacity building of testing for Monkeypox at Maximum containment laboratory, we have procured primer and probes for detection of non-variola orthopox.
• Real time PCR for orthopox was validated using Buffalopox tissue culture fluid as positive control.