TRANSLATIONAL RESEARCH CONSORTIUM FOR CHIKUNGUNYA VIRUS

Chikungunya is a re-emerging viral infection worldwide and India is seeing outbreaks almost every year. Chikungunya outbreaks have been reported in several parts of India, with a significant number of morbidities. Efforts to produce an effective vaccine against the infectious agent are ongoing around the world, but the presence of multiple subtypes makes it a challenging target to hit. Despite the fact that the number of Chikungunya infections has gradually increased over time, there is relatively little information on the genetic variation of the circulating strains in India. There is lack of data and relatively little evidence on the immune response of a convalescent individual, making it difficult to understand the effects of a vaccination, when one is available.

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In order to shed more light in these areas, a research consortium (Translational 沙巴体育 Consortia (TRC) for Chikungunya virus) was formed by 沙巴体育 Institute of Virology, 沙巴体育 Academy of Higher Education. The 沙巴体育 Centre for Genetic Engineering and Biotechnology (ICGEB) in New Delhi, the Institute of Life Sciences (ILS) in Bhubaneshwar, the All India Institute of Medical Sciences (AIIMS) in Bhubaneshwar, the Post-Graduate Institute of Medical Education and 沙巴体育 (PGIMER) in Chandigarh, and the Topiwala National Memorial Hospital (TNMC and BYL Nair Charitable Hospital (TNMC and BYL Nair Charitable Hospital) are collaborating partner institutes in this consortia with MAHE. The clinical sites for the research project are spread across the country in nine Indian states: Karnataka, Kerala, Tamil Nadu, Maharashtra, Odisha, Gujarat, Tripura, Assam, and Chandigarh. The research study will take 48 months to complete. (Start date: 30 May 2019; expected completion date: 29 May 2023). The Department of Biotechnology, Government of India, has supported this research study through BIRAC (Biotechnology Industry 沙巴体育 Assistance Council).

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Major objectives of this research consortia is to establish a biobank of circulating Chikungunya viral strains in the country, along with a serum bank of na?ve, early stage acute infection and convalescent samples to understand the differences in the immune status. To understand the modulation in the immune responses of chikungunya infected individuals; the inflammatory cytokines, chemokines, and growth factor levels will be measured at different stages of the infection along with T-cell and B-cell phenotyping. With the proposed objectives, the consortia will be able to sketch a complete immune profiling of acute and chronic infections. The source of these samples will be patients coming to the participatory hospitals who will be followed up with regular collection of samples. The circulating viral strains isolated from infected individuals will be sequenced to identify subtypes and mutations within the Indian subcontinent and will be used to develop standardized high throughput assays for viral quantification and infectivity. An animal model of Chikungunya will also be developed to understand the disease progression in acute and chronic stages of infection and correlated with symptoms in humans.?

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Environmental and Health Risk Management Plan

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1.??????????? Environmental Impact and risk mitigation

Risks

Project Specific Risk

?Potential Impact

Mitigation Steps

Air Pollution

Minimal Risk

Project implementation will not cause any adverse air pollution.

Project implementation will not cause any adverse air pollution.

Water Pollution and Wastewater treatment

Minimal Risk

Project implementation will not cause any adverse water pollution

Project implementation will not cause any adverse water pollution.

Chemical waste

Minimal Risk

Project implementation will not cause any adverse chemical waste.

Project implementation will not cause any adverse chemical waste.

Biological Waste

Minimal Risk

There will be biological waste of blood samples and Viruses

Inactivated at source by Hypochlorite.

Further, autoclaved before handing over to Biomedical waste management agency

Heavy metals

Minimal Risk

Project implementation will not cause any adverse heavy metal waste.

Project implementation will not cause any adverse heavy metal waste.

Radiation Waste

Minimal Risk

Project implementation will not cause any adverse radiation waste

Project implementation will not cause any radiation waste

Destruction/alteration of surrounding ecosystem

Minimal Risk

Project implementation will not cause any adverse destruction/alteration of surrounding ecosystem waste

Project implementation will not cause any adverse destruction/alteration of surrounding ecosystem waste

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2.??????????? Occupational Health and Safety and risk mitigation

Risks

Project Specific Risk

?Potential Impact

Mitigation Steps

Heat Hazards

Minimal Risk

Project implementation aspects will not cause any heat hazards

Project implementation aspects will not cause any heat hazards

Chemical hazards, including fire and explosions

Minimal Risk

Injuries, property loss

Fire Extinguisher, Fire hydrant system is in place.

Pathogenic and biological hazards

Minimal Risk

There will be blood samples from cases of

Chikungunya Virus

Inactivated at source by Hypochlorite.

Further, autoclaved before handing over to Biomedical waste management agency

Radiological hazards

Minimal Risk

Project implementation aspects will not cause any radiological hazards.

Project implementation aspects will not cause any radiological hazards.

Noise

Minimal Risk

Project implementation aspects will not cause high noise level.

Project implementation aspects will not cause high noise level.

Process safety

Minimal Risk

Engineering and equipment maintenance shall be undertaken as per SOPs.?

Process risk assessment and engineering control.

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3.??????????? Community Health and Safety and risk mitigation

Risks

Project Specific Risk

?Potential Impact

Mitigation Steps

Safety Transportation Management System (for transport of hazardous material)

Minimal Risk

Human blood samples from suspected cases of Chikungunya Virus infection might spill.

Infected samples will be packed in triple layer and transported under cold chain to avoid spillage

Emergency preparedness and participation of local authorities and potentially affected communities

Minimal Risk

Localised

Spill management training and onsite emergency plan, mock drills, communication mechanism to neighbouring centre

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In case your organization already has EHS guideline, please summarise the same.

If not, please describe the impact because of hazardous material, release of chemicals, biologicals, management of catastrophic events like fire/explosion.

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Notwithstanding the above other risk (relevant to the project activities) that will be identified in the course shall be addressed as per standard mitigation monitoring parameters and manner of records keeping shall be in accordance with the recommendations of the project monitoring committee on subject experts engaged by BIRAC

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