Rapid Response for Mpox Research

1.3 Award Value and Duration

• Award Value/Project: Maximum of $100,000.
• Grant Term: 6-12 months (Non-renewable)

1.4 Key Dates

• Competition Launch: September 2024
• Full Application Deadline: October 30, 2024, at 5:00 PM Eastern time
• Anticipated Results Announcement: December 2024

1.5 Eligible Expenses

Expenses are for direct costs of research and must comply with the CFREF Administration Guide. Eligible expenses include:

• Salaries and benefits of HQP, student stipends, professional & technical services, and honoraria
• Equipment (under $10,000), supplies, consumables and user fees (including use of core facilities). $10,000 is the combined maximum for all pieces of equipment.
• Computers and electronic communications
• Travel and subsistence: for field work, conferences and other research-related travel
• Dissemination of results & networking
• Services and other eligible expenses

1.6 Applicant Eligibility

Principal Investigator (PI) Eligibility

• McGill University faculty members.
• Eligible to hold Tri-Agency research funding.

Co-Investigator (Co-I) Eligibility

• McGill University faculty members.
• Researchers from D2R’s partner institutions (e.g., McMaster University, University of British Columbia, University of Ottawa, Université de Sherbrooke). These researchers must be included in the list provided by the partners and approved by D2R.
• Eligible to hold Tri-Agency research funding.

Collaborators

• Individuals from McGill, other academic institutions, industry, government, or community organizations who contribute meaningfully to the project. Collaborators are not eligible to receive funding from D2R.

Limitations

• The application limitation within a funding cycle set for some of D2R’s funding programs does not apply to the D2R Rapid Response Program for Mpox Research.

The full application consists of an online form and specific documents to upload.

We recommend gathering all necessary information and documents before beginning the online form, as it needs to be completed in one session as it does not support saving and resuming.

2.1 Online Application Form

The online application form Includes the following sections:

• Principal Investigator’s identification
• Principal-Investigator’s Early Career Researcher status
• Co-Investigator(s) identification
• Collaborator(s) identification
• Full Project Title
• Five keywords
• Lay abstract (up to 100 words)
• Alignment with D2R Foundational Axes
• Project duration
• Requested budget amount
• Description of research data

2.2 Documents to Upload

• Project Description (template)
• Biosketches (template). A biosketch is required for the Principal Investigator, each Co-Investigator, and any named Postdoctoral Fellow(s). Biosketches for Collaborators are not required
• Budget and Justification (template)

Use the template for each document. Combine the Proposal and Biosketches into one PDF file prior to uploading (maximum size 10 MB).

2.3 Project Description Instruction

• Page limits: 6 pages, inclusive of references.
• Figures and images may be used but must fit within the stated page limit.
• Appendices are not permitted.
• Submissions that exceed the maximum page limit will have the extra pages removed prior to review.

A. Scientific Summary

• An overview of the project’s objectives, methods, and expected outcomes.
• Identify the project’s potential benefits and contributions to global public health.

B. Introduction and Background

• Situate the project within the current landscape of knowledge.
• Explain how the project will fill scientific gaps, provide proof-of-concept, or introduce novel research directions, specifically addressing one or more of the identified research priorities.

C. Proposal

• Clearly state how the proposal aligns with one or more of the listed research priorities and explain how the findings will contribute to public health actions.
• Describe the project's objectives and methods (experimental or otherwise) based on the chosen research priority area.
• Explain how the project makes use of existing resources (e.g., serology samples, DNA from cohorts) to deliver impactful results within the program’s timeframe, including the development of new diagnostic tests, vaccines, or other tools.
• Discuss the immediate public health impact of the project, including its potential to inform future responses or initiatives.
• Describe the knowledge translation plan, including how the results will be rapidly translated into public health actions or inform policies to address Mpox.
• Explain how Equity, Diversity, and Inclusion (EDI) factors have been integrated into the research design, addressing factors such as sex, gender, physical ability, race, and age. If EDI considerations are not applicable, provide an evidence-based rationale.
• For projects requiring CL3 facilities, include a detailed description of the certified facility where the work will be conducted, with appropriate proof of access to the facility.

D. Research Team and Collaborations

• Outline the roles of each team member and how their contributions will support the project.
• Detail how the team will coordinate activities, particularly if members are based at different institutions.
• Explain strategies to foster collaboration, create synergies, and pool resources with related research projects to enhance impact.
• Summarize any existing or potential partnerships and funding opportunities that could support the project's immediate goals and enhance its impact.
• Describe what measures are being implemented to support EDI in research practice (e.g. recruitment, team composition, training opportunities, mentorship, knowledge dissemination).

E. Budget

• Provide a high-level summary of the budget and justifications, especially for expenses which may require additional context.

F. References

• List only works cited in the Project Description.
• Include DOIs where available

3.1 Administrative Review

An administrative review of each submission will be conducted for both Principal Investigator and Co-Investigator(s) eligibility and application completion. Submissions that do not comply with program requirements will be eliminated from further consideration.

3.2 Strategic Alignment and Scientific Merit Evaluation

The evaluations will be carried out by experts from D2R’s Infectious Diseases Working Group and the D2R Strategic Alignment Review Committee.

1. Alignment with the Mpox Call Mission:
   This will be assessed as Yes or No, based on how well the proposal aligns with the specific objectives and urgency of the Mpox Rapid Response Program, and its potential to generate data or insights that can be rapidly translated into public health actions.
2. Scientific Merit: Each of the following will be scored on a scale of 1 (poor) to 20 (excellent):
   • Originality and Innovation: The degree to which the proposal presents new and creative ideas that push the boundaries of current research on Mpox, contributing to new diagnostics, treatments, or preventive measures.
   • Research Plan Feasibility: The likelihood that the proposed research plan can effectively achieve its objectives or deliver measurable outcomes within the 6-12 month timeframe, considering available resources and challenges.
   • Research Team Quality and Contributions: The expertise and capabilities of the researchers and trainees involved, including how well the team and collaboration are structured to achieve the project's goals.
3. Integration of EDI Considerations:
   This will not be scored but will be evaluated for sufficiency. For projects deemed fundable, Principal Investigators will be notified of any issues (i.e., insufficient or inadequate) regarding the integration of EDI considerations. Principal Investigators will have the opportunity to revise these sections. Revised sections must be satisfactorily updated and approved before the release of funds.

4.1 Funding Decision

The D2R Research Steering Committee (RSC) will consider both the alignment and scientific merit evaluations in its funding decisions. A positive alignment with the Mpox Call’s mission and objectives is a prerequisite for funding. Among the aligned projects, those with the highest scientific merit scores (evaluated on a scale of 0 to 20 for originality, feasibility, and team quality) will be prioritized for funding.

4.2 Announcement of Results

Principal Investigators will be informed of the result by email in December 2024.

4.3 Notice of Award

Successful applicants will receive a Notice of Award, which details the terms, conditions, and reporting obligations.

Email: d2r.funding@mcgill.ca

Information for facilities where work with Mpox (Monkeypox) Virus is conducted

On August 14, 2024, the World Health Organization Director General issued a statement declaring that the increase in mpox cases in the Democratic Republic of the Congo and a growing number of countries in Africa, as well as the emergence of a new sub-lineage of clade I mpox virus (MPXV clade Ib) constitute a Public Health Emergency of International Concern (PHEIC). A previous PHEIC for mpox was in place between June 23, 2022 and May 10, 2023, given a multi-country outbreak of mpox caused by clade IIb MPXV in previously non-endemic countries, including Canada.

As of August 16^th, the risk to people in Canada from mpox remains low. However, as the global situation evolves, continued surveillance and preparedness are critical. The Public Health Agency of Canada (PHAC) is monitoring and responding to the developing situation to provide Canadians with evidence-based information and guidance. The PHAC Centre for Biosecurity, in consultation with the Canadian Food Inspection Agency (CFIA) Office of Biohazard Containment and Safety (OBCS), has developed these frequently asked questions & answers to help support our stakeholders in understanding and meeting their regulatory obligations with respect to MPXV and the Human Pathogens and Toxins Act and associated Regulations (HPTA/R) and the Health of Animals Act and associated Regulations (HAA/R).

Please also consult the:

• MPXV biosafety advisory
• MPXV Laboratory licensing information
• Pathogen Safety Data Sheet
• webinar on MPXV delivered in 2022

Any questions or concerns can be sent to biosafety.biosecurity@phac-aspc.gc.ca.

Q1. What risk group is Mpox virus (MPXV)?

MPXV is classified as a Risk Group 3 (RG3) human and RG3 animal pathogen and is regulated under the Human Pathogens and Toxins Act and Regulations (HPTA/R) and the Health of Animals Act and Regulations (HAA/R). It is also considered a prescribed human pathogen, or a security sensitive biological agent (SSBA).

Q2. What containment level do I need to conduct controlled activities with Mpox virus (MPXV)?

All controlled activities including in vitro and in vivo research, or non-research activities with Mpox virus (MPXV) are to be performed in accordance with an RG3 SSBA Pathogen and Toxin Licence issued under the HPTA and in a facility that meets the minimum applicable requirements for containment level 3 (CL3), as described in the Canadian Biosafety Standard (CBS).

Please consult the Scientific Research Policy for Human Pathogens and Toxins for more information on research activities.

Q3. What containment level do I need to conduct diagnostic activities with patient samples suspected or known to be infected with Mpox virus (MPXV)?

Primary specimens (e.g., skin lesion scrapings, tissue biopsies, rectal swabs, blood collected directly from patients) are excluded from the HPTA and are not regulated by the PHAC as a human pathogen, provided the pathogen will not be cultivated or intentionally collected or extracted (i.e., concentrated, cultured).

Important Note: If primary specimens (e.g. human, animal, environmental) or other materials that contain MPXV (including any derivatives of them) are imported, they are regulated under the HAR and facilities are to meet the requirements of the Canadian Biosafety Standard.

When conducting non-propagative diagnostic activities that do not result in the concentration or extraction of MPXV (e.g., PCR testing performed directly from primary specimens), it is recommended to follow good microbiological laboratory practices and universal precautions in work areas where primary specimens are handled. As described in the Canadian Biosafety Guideline: Human Diagnostic Activities, facilities are encouraged to conduct a local risk assessment (LRA) for diagnostic activities, which takes into consideration the potential for infectious aerosol and droplet production and the risk of exposure. This will assist in determining appropriate mitigation measures that reduce site-specific and activity-specific risks in a way that is feasible for the facility.

If or when it is determined through an LRA that non-propagative diagnostic activities may result in the inadvertent concentration or extraction of MPXV, it is recommended that facilities meet the minimum requirements for containment level 2 (CL2), as described in the CBS.

As more information regarding the current outbreak of mpox becomes available, it may be determined that there is a lower risk of exposure when handling certain types of primary specimens. For example, preliminary evidence suggests that blood poses a lower risk of exposure compared to skin lesion swabs or scraping because of the short duration of viremia early in the course of the infection, usually before the skin lesions appear[1]^,[2]. PHAC will update information as needed.

Q4. What permits and licences are required to import Mpox virus (MPXV)?

MPXV is a Risk Group 3 (RG3) human and RG3 terrestrial animal pathogen, as well as an SSBA. It is regulated under Human Pathogens and Toxins Act and Regulations (HPTA/R) and the Health of Animals Act and Regulation (HAA/R). The following describes what material requires authorization to import, which authorization is required, and whether it is issued by PHAC or the CFIA.

Pure culture of MPXV - requires an RG3 SSBA Pathogen and Toxin Licence (PTL) issued under the HPTA/R and HAA/R, issued by PHAC.

Human, plant, or environmental samples that contains MPXV – requires an RG3 Pathogen and Toxin Licence (PTL) issued under the HAA/HAR only, issued by PHAC. An RG3 SSBA PTL issued under the HPTA/R may also be required if the virus will be cultivated or intentionally collected or extracted.

Animal product/animal by-product containing MPXV – requires an Animal Pathogen Import Permit issued by CFIA. An RG3 SSBA PTL issued under the HPTA/HPTR may also be required if the virus will be cultivated or intentionally collected or extracted.

An Animal Pathogen Transfer Permit is required to transfer any imported material or its derivatives containing MPXV to a location other than that specified on the Animal Pathogen Import Permit or Animal Pathogen Transfer Permit.

Please contact the Centre for Biosecurity licensing team at PHAC by email licence.permis@phac-aspc.gc.ca for more information on what type of Pathogen and Toxin Licence you require.

For information on obtaining a Terrestrial Animal Pathogen Import Permit, Terrestrial Animal Pathogen Transfer Permit or CL2 Facility Compliance Letter issued by CFIA, please contact 1-800-442-2342 or permission@inspection.gc.ca.

For information on CL3 facility certification by CFIA, please contact the Office of Biohazard Containment and Safety (OBCS) at .

Q5. What is required to ship Mpox virus (MPXV) patient specimens?

The transportation (packaging, shipping, receiving) of infectious substances is subject to the Transportation of Dangerous Goods Act and Regulations, administered by Transport Canada. Personnel shipping materials that contain or may contain MPXV require Transportation of Dangerous Goods training.

The Transportation of Dangerous Goods temporary certificate TU 0886.1, which allows for relaxed shipping requirements for patient specimens that may contain MPXV remains valid until July 31, 2025.

For further information, please refer to the Transport Canada Shipping Infectious Substances bulletin. To obtain further assistance, contact Transport Canada at: TDG-TMD@tc.gc.ca.

Q6. Do laboratory personnel require an HPTA Security Clearance to work with Mpox virus (MPXV)?

Yes, an HPTA Security Clearance is required to conduct controlled activities with MPXV as it is a Security Sensitive Biological Agent (SSBA). The area in the facility where the virus is handled or stored is only accessible to individuals with a valid Security Clearance issued under the HPTA or to individuals under 1:1 accompaniment and supervision by an individual with a valid Security Clearance issued under the HPTA. These Security Clearances are issued by PHAC with the help of security and intelligence partners. Please refer to our website for more information on SSBAs and the HPTA Security Clearance program, as well as the program’s associated Service Standards. Note: an HPTA Security Clearance is not required for non-propagative diagnostic work with primary specimens as they are excluded from the HPTA.

Q7: My organization already has a Pathogen and Toxin Licence for work with RG3 pathogens including SSBAs, and we would now like to work with Mpox virus (MPXV). What do we need to do?

You will need to submit an amendment to add MPXV to your existing RG3 SSBA Pathogen and Toxin Licence via PHAC’s Biosecurity Portal. As part of the licensing process, your organization may be required to submit additional documentation to demonstrate compliance with the conditions of the licence, which include adhering to the applicable requirements described in the Canadian Biosafety Standard for containment level 3 (CL3).

If you are importing or would like to work with an imported animal product or by-product that contains MPXV , you will also need to request an Animal Pathogen Import or Transfer Permit from the CFIA.

Q8: My organization would like to work with Mpox virus (MPXV) and has an RG3 Pathogen and Toxin Licence, but we don’t have authorization to work with SSBAs. What do we need to do?

You will need to submit a new licence application for a Pathogen and Toxin Licence authorizing RG3 SSBA in order to work with MPXV. This can be done via PHAC’s Biosecurity Portal. Secondly, you will need to submit an associated HPTA Security Clearance application. It is recommended to submit as early as possible as this is a rate-limiting step for issuing a licence authorizing work with SSBAs.

As part of the licensing process, your organization may be required to submit additional documentation to demonstrate compliance with the conditions of your licence, which include adhering to the applicable requirements described in the Canadian Biosafety Standard for containment level 3 (CL3).

Q9. My organization has a laboratory that was previously certified to an older Canadian biosafety guideline or standard for containment level 3 (CL3) activities but is now being used as a containment level 2 (CL2) laboratory. We are considering reactivating this laboratory in order to do work with Mpox virus (MPXV). What do we need to do?

Please reach out to the Centre for Biosecurity at biosafety.biosecurite@phac-aspc.gc.ca so that we can provide you with the best possible guidance on the requirements necessary for reactivation and subsequent licensing of your CL3 laboratory to work with MPXV. Include the following in your correspondence:

• What type of work is expected to be done with MPXV? In vitro and/or in vivo?
• Do you plan to work with RG3 pathogens other than MPXV in this laboratory?
• Was this containment zone initially certified as a CL3 Laboratory Work Area only, CL3 Small Animal Zone or CL3 Large Animal Zone?
• Which Canadian Biosafety Guideline(s)/Standard(s) was this containment zone initially certified to?

This information is necessary in determining the compliance documentation that will need to be submitted and potential performance and verification testing that may need to be completed in order for PHAC to authorize an RG3 Pathogen and Toxin Licence for work at CL3. Additionally, an HPTA Security Clearance and review of an organization’s Biosecurity Plan is required for issuing an SSBA Pathogen and Toxin Licence.

Centre for Biosecurity, Regulatory, Operations and Emergency Management Branch

Public Health Agency of Canada / Government of Canada

pathogens.pathogenes@phac-aspc.gc.ca / Tel: 613-957-1779

[1] World Health Organization. 2022. Monkeypox Fact Sheet. Retrieved 05/30, 2022 from https://www.who.int/news-room/fact-sheets/detail/monkeypox

[2] World Health Organization. 2022. Laboratory testing for the monkeypox virus: Interim guidance. Retrieved 05/30, 2022 from https://www.who.int/publications/i/item/WHO-MPX-laboratory-2022.1

In case useful, the below is a list of projects that were recently funded from CIHR’s Mpox-focused funding programs.

Team Grant: Monkeypox Rapid Research Response

Project Title:	Canada-Africa Monkeypox Partnership (CAMP): Characterizing transmission dynamics and evaluating medical countermeasures to inform the clinical and public health response to Mpox
Principal investigator(s):	Tan, Darrell H; Adebajo, Sylvia; Audu, Rosemary; Chan, Adrienne; DAODU, OLUWAFEMI B; Klein, Marina B; Kozak, Robert A; Kwong, Jeffrey C; McGeer, Allison J; Mishra, Sharmistha; Okpokoro, Evaezi; Olufadewa, Isaac I; Walmsley, Sharon L
Institutions:	Unity Health Toronto
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=471053&lang=en

Project Title:	A prospective and retrospective multi-center, cohort study for clinical, virologic and immunologic characterization of monkeypox virus clade IIb by the International Monkeypox Response Consortium (IMREC)
Principal investigator(s):	Kindrachuk, Kenneth J; Ansumana, Rashid; Mbala, Placide K
Institutions:	University of Manitoba
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=471094&lang=en

CIHR Team Grant for Mpox and zoonotic threats

Ecological and zoonotic

Project Title:	Investigation of Mpox virus spillover and spillback at the human-animal interface in the Democratic Republic of Congo
Principal investigator(s):	Kelvin, Alyson A; Forbes, Kristian M; Kindrachuk, Kenneth J; Rimoin, Anne W
Institutions:	University of Saskatchewan
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481127&lang=en

Project Title:	Strengthening global and regional health security through surveillance of emerging Poxviruses in humans, domestic and peri-domestic animals, and wildlife
Principal investigator(s):	Kelvin, David J
Institutions:	Dalhousie University (Nova Scotia)
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481128&lang=en

Project Title:	Assessing mpox virus susceptibility, transmission, host immune responses, and virus evolution in key Canadian livestock species
Principal investigator(s):	Kozak, Robert A; Facciuolo, Antonio
Institutions:	Sunnybrook Research Institute (Toronto, Ontario)
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481270&lang=en

Project Title:	Mpox exposure and transmission at the human-animal interface; a One Health approach to viral ecology
Principal investigator(s):	Mubareka, Samira; Osborn, Andrea L
Institutions:	Sunnybrook Research Institute (Toronto, Ontario)
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481130&lang=en

Project Title:	Understanding susceptibility and permissiveness to mpox virus across diverse mammalian species
Principal investigator(s):	Mossman, Karen L
Institutions:	McMaster University
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481129&lang=en

Intersection of mpox and STBBI

Project Title:	Investigating Immunogenicity of Mpox and Mpox vaccine Imvamune in people living with HIV
Principal investigator(s):	Costiniuk, Cecilia T
Institutions:	Research Institute of the McGill University Health Centre
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481131&lang=en

Project Title:	Pre-exposure mpox vaccination campaigns aimed at GBTMSM+ and sex work communities: What worked in 2022 and what can we learn to strengthen future targeted vaccination campaigns to stigmatized communities in infodemic times?
Principal investigator(s):	Greyson, Devon; Schwandt, Michael
Institutions:	University of British Columbia
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481268&lang=en

Interventions and risk management

Project Title:	Optimizing Mpox surveillance strategies and preventing epidemic resurgence: a three-province mathematical modeling study
Principal investigator(s):	Irvine, Michael A; Maheu-Giroux, Mathieu; Mishra, Sharmistha; Sbihi, Hind
Institutions:	Simon Fraser University (Burnaby, B.C.), B.C. Centre for Disease Control (Vancouver
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481133&lang=en

Project Title:	SMART (Smallpox vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
Principal investigator(s):	Loeb, Mark B; Halperin, Scott A
Institutions:	McMaster University
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481134&lang=en

Public health

Project Title:	Epidemiological modelling of behavioural impact on Mpox mitigation strategies
Principal investigator(s):	Nasri, Bouchra; Malta, Monica; Moyles, Iain
Institutions:	Université de Montréal, Centre de recherche en santé publique (Montreal, Quebec)
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481271&lang=en

Project Title:	Impact of host responses on mpox pathogenesis and tecovirimat efficacy in the Collaborative Cross mouse model of genetic diversity
Principal investigator(s):	Rasmussen, Angela
Institutions:	University of Saskatchewan
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481136&lang=en

Social & Behavioural Sciences

Project Title:	Learning from mpox: Community-Based Mixed Methods Research to Support Intersectional and Stigma-Informed Approaches to Pandemic Preparedness for Gay, Bisexual, Queer, and Other Men who Have Sex with Men in Canada
Principal investigator(s):	Grace, Daniel; Cox, John J; Kwag, Michael; Grey, Cornel; Lachowsky, Nathan J; Tan, Darrell H
Institutions:	University of Toronto
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481269&lang=en

Project Title:	Modelling, predicting and risk assessment of mpox (monkeypox) and other (re)emerging zoonotic threats to inform decision-making and public health actions: mathematical, geospatial and machine learning approaches
Principal investigator(s):	Woldegerima, Woldegebriel Assefa
Institutions:	York University (Toronto, Ontario)
Link :	https://webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=481139&lang=en