Translational 沙巴体育 Consortium (TRC) for establishing platform technologies to support prophylactic and therapeutic strategies for Dengue – Discovery to proof of concept
“Translational 沙巴体育 Consortium (TRC) for establishing platform technologies to support prophylactic and therapeutic strategies for Dengue – Discovery to proof of concept, is funded by BIRAC, DBT, Govt. of India”, under Industry-Academia Collaborative Mission for accelerating discovery research to early development for biopharmaceuticals.
This four-year project (June 2019- April 2023) is funded for an amount of 153.02 lakhs INR to 沙巴体育 Academy of Higher Education as Grant-in aid, by Biotechnology Industry 沙巴体育 Assistance Council (BIRAC), Department of Biotechnology, Government of India (Ref No. BT/NBM0099/02/18). In this research consortium, MAHE, as one of the clinical collaborators, has partnered with research institutions such as 沙巴体育 Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi; Translational Health Science and Technology Institute, Faridabad; National Institute of Immunology (NII), New Delhi; Indian Institute of Technology, New Delhi; and clinical partners namely Christian Mission Hospital (CMC), Vellore; and All India Institute of Medical Sciences, New Delhi to conduct Dengue translational research work in India.
The main objective of MAHE, as a clinical field site, is to enroll and collect dengue asymptomatic clinical samples (dengue NS1 or IgM positive) during dengue outbreak and follow-up.? A potential asymptomatic case will be a person of the same household or person from same locality of a dengue positive case identified during a hospital visit or during a dengue outbreak. Depending on the frequency of asymptomatic individuals, MAHE aims to identify at least 25 asymptomatic individuals over a span of four years, which will be a mix of adults and children. Two acute phase samples and 1 follow up at 4 – 12 weeks will be collected from the enrolled patients. In addition to the asymptomatic cases, MAHE will also enroll 50-60 symptomatic (adult and children) hospitalized or field cases (2 acute phase samples) + 1 follow up at 4 – 12 weeks, to support the numbers of dengue clinical cases in the consortia. All blood samples will be processed at MIV, MAHE for the separation of plasma and PBMCs. Paired whole blood, plasma and PBMCs for all asymptomatic and symptomatic individuals enrolled in the study will be shipped to ICGEB, New Delhi. Clinical data will be collated and transferred to the Project Management Team, Clinical Development Services Agency, New Delhi. The current study has been approved by the MAHE Institutional Ethical Committee (No: MAHE EC/005/2020; Dated: 30.08.2019).
Environmental and Health Risk Management Plan
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 |
? 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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