ResearchNet - RechercheNet

Table of Contents

• Description
• Objectives
• Eligibility
• Guidelines
• Performance Measurement
• Review Process and Evaluation
• How to Apply
• Contact Information
• Sponsor Description
• Additional Information

Description

Background

There are currently 36.7 million people living with HIV worldwide.  While the number of people receiving treatment has grown to 17 million— an increase of two million from 2014 – for the first time in 15 years, new infections have also gone up. For every person newly receiving treatment in 2015, one person was newly infected with the virus. Vulnerable populations living in low-resource communities are disproportionately affected by HIV, with sub-Saharan Africa accounting for 60% of new infections.

A durable end to the epidemic is not feasible without the development of an HIV vaccine. Vaccines are one of the most effective and cost-effective public health tools, as evidenced in the eradication of smallpox, near-eradication of polio, and containment of other serious infectious diseases that caused widespread morbidity such as diphtheria, tetanus, pertussis, measles and rubella. The addition of a well-implemented, 70% efficacious vaccine to the comprehensive AIDS response could reduce annual new HIV infections globally by over 40% in the first decade and by over 60% in the first 25 years. Over time, reducing the number of people needing treatment in half would significantly reduce treatment costs and, therefore, total global response costs. In addition, a vaccine would be long-term, discreet and cost-effective, circumventing many of the barriers of protection from HIV that key populations, particularly women and girls in low-resource settings, face. With an HIV vaccine as a key component to the global response package, an end to the AIDS epidemic would be conceivable.

Researchers are exploring the use of replicating viral vector vaccines against HIV to mimic the high-level efficacy seen with live attenuated viruses like the measles, mumps, and rubella vaccines, but which will not be advanced in HIV due to safety concerns.  Vesicular stomatitis virus (VSV) was selected as a platform for a live chimeric viral vector as VSV can display authentic and functional HIV Envelope proteins (Env) on its viral particle. Furthermore, a live chimeric VSV vaccine has been advanced as a human vaccine candidate recently; the VSV-ZEBOV Ebola virus vaccine, with design and early development led by the Public Health Agency of Canada, is a chimeric virus in which the functional Ebola virus glycoprotein (GP) substitutes for VSV G. VSV-ZEBOV was recently shown to be safe and 100% efficacious in preventing Ebola infection in an open-label, cluster-randomized ring vaccination trial in an endemic region of Africa¹.

Recent results of a recent HIV vaccine preclinical trial show that the prototype vaccine – VSV-HIV Env – can protect 67% of monkeys against infection, a level of protection that matches or exceeds any HIV vaccine candidate currently in development.  In partnership with the International AIDS Vaccine Initiative (IAVI), the Canadian Institutes of Health Research (CIHR) will harness Canadian expertise in immunology, virology and vaccinology, linking this capacity to global efforts to accelerate the design and development of a safe, effective, globally accessible VSV-HIV Env vaccine, optimize the vaccine for global delivery, and strengthen existing regulatory and clinical capacity to test the vaccine safely and ethically in Africa, where the burden of AIDS is highest. Successful implementation of this partnership will set the stage for future HIV vaccine efficacy trials and will have broad-ranging collateral benefits across other diseases, while strengthening health research systems and building capacity in countries most affected by AIDS. IAVI will provide access to the vaccine candidate and other reagents to successful grantees, offer space in their labs for trainees on relevant projects and co-host meetings between the Canadian funded researchers and key stakeholders who are advancing HIV vaccines. IAVI will have sole discretion as to which of its vaccine candidates and research reagents it will provide access to as part of this program.

Purpose

This funding opportunity supports the development of safe, effective, globally available HIV vaccines through enhancement of a leading replicating viral-vector based candidate: VSV-HIV.

Funds Available

CIHR and partner(s) financial contributions for this initiative are subject to availability of funds. Should CIHR or partner(s) funding levels not be available or are decreased due to unforeseen circumstances, CIHR and partner(s) reserve the right to reduce, defer or suspend financial contributions to grants received as a result of this funding opportunity.

• The total amount available for this funding opportunity is $4,000,000. This amount may increase if additional funding partners participate. Applicants should submit a budget that is in line with the needs of the proposal that does not exceed $1,333,333 per year for up to three years. Approved applications may receive an across-the-board cut to the budget (maximum 15%), if necessary, to maximize the number of grants funded.

Partner and Internal Collaborator Participation

CIHR is dedicated to identifying and developing collaborations with other funding organizations and stakeholders to enhance the availability of funding for this strategic initiative, and to create, where appropriate, opportunities for knowledge exchange and translation related to the scope of this particular initiative. Applicants are invited to visit the Partner and Internal Collaborators Description sections  to find a list of partners, internal collaborators and their respective mandates and/or strategic interests. The specific research foci and requirements for each partner and internal collaborator are outlined in the “Objectives” section.

The opportunity to add new partners and internal collaborators to this funding opportunity may arise after publication. These partners and internal collaborators may not be listed, however, the principles that govern relevance review and funding decisions will still apply in these cases; see Review Process and Evaluation. Note: Where new partners and internal collaborators are added later in the competition, the partners and internal collaborators will conduct relevance reviews based on their respective mandates on all applications in this competition without reference to peer review results. Applications deemed to be relevant will be funded from the top down as far as the budgets will allow.

Objectives

The specific objectives of this funding opportunity are to:

• Accelerate the development of a safe, effective and globally available VSV-HIV vaccine.
• Link Canadian researchers and trainees to the global HIV vaccine effort.

Relevant Research Areas

The CIHR HIV/AIDS Research Initiative will provide funding for applications that are determined to be relevant to the following research areas:

• Modifying the VSV vector for efficient and maximal expression of HIV genes and/or epitopes intended to induce protective immunity as an HIV vaccine candidate;
• Identifying vaccine process development technologies that support efficient scale up and purification of the VSV-vectored HIV vaccines; or
• Enhancing understanding of immune responses to support the evaluation of HIV VSV vector vaccines.
• Applicants may, but are not required, to address all three research areas in their applications.

Eligibility

Eligibility criteria for all CIHR research funding programs apply. The business office of the institution of an eligible Nominated Principal Applicant generally administers CIHR funds. Refer to the Individual Eligibility Requirements regarding the eligibility requirements for individuals and institutions.

Eligibility to Apply

For your application to be eligible:

1. The Nominated Principal Applicant must be an independent researcher.
2. The Nominated Principal Applicant must be appointed at an eligible institution (See Institutional Eligibility Requirements for eligibility process and associated timelines) at the time of application.
3. Each application must include funds to support capacity building of Canadian trainees.
4. Each application must include funds to support annual travel to an international research meeting on HIV vaccine to participate in a research exchange meeting.
5. Each application must include a letter of collaboration from IAVI recognizing the appropriateness/relevance of the proposed research program.

Randomized Controlled Trials

Applications involving Randomized Controlled Trials (RCT) are accepted and encouraged where appropriate based on scientific and methodological grounds.

Guidelines

General CIHR Guidelines

This funding opportunity will comply fully with the policies and guidelines as outlined in CIHR's Funding Policies. CIHR policies reflect areas of importance such as (but not limited to): Gender and Sex-Based Analysis, Knowledge Translation, Open Access, Global Health Research and International Collaborations. Policies and guidelines also cover areas such as applicant responsibilities, Official Languages policy, Access to Information Act, Privacy Act, Tri-Agency Open Access Policy on Publications and Communication Requirements. Information collected by CIHR may be shared as described in the Conflict of Interest and Confidentiality Policy of the Federal Research Funding Organizations.

Allowable Costs

Recipients should review the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Financial Administration Guide for a complete listing and description of allowable costs and activities.

Conditions of Funding

Successful applicants funded through this funding opportunity and any other persons working on the project must comply fully with the CIHR Funding Policies. Policies and guidelines cover areas such as Applicant Responsibilities, Official Languages policy, Access to Information and Privacy Acts, and Acknowledgement of CIHR's Support. Successful applicants will be informed of any special financial requirements prior to the release of funds or when they receive CIHR's Authorization for Funding (AFF) document.

In addition to CIHR standard guidelines and requirements, the following special requirements shall apply:

• Special Note: IAVI  intends to provide in-kind support to this initiative by giving access to their vaccine candidate to successful grantees, offering space in their labs for trainees on the projects and co-hosting a meeting between the Canadian team and the IAVI team, all of which will be matters between IAVI and grantees with no involvement whatsoever from CIHR.  IAVI will have sole discretion as to which of its vaccine candidates and research reagents it will provide access to as part of this program. Grantees who are provided access to IAVI’s site or are provided IAVI’s vaccine candidates will be limited to conducting research for the purpose provided in the grant application and will be required to enter into IAVI’s standard visiting scientist research agreement and/or material transfer agreement, as appropriate. CIHR shall have no responsibility or liability whatsoever in relation to IAVI’s site, the hosting of trainees or IAVI’s vaccine.

Performance Measurement

CIHR is committed to collecting and disseminating information on the outputs and impacts of the research it funds. This information is an important part of CIHR accountability within the Federal Government and to Canadians. If successful within this funding opportunity:

• The Nominated Principal Investigator will be required to share the full applications with IAVI.
• The Nominated Principal Investigator will be required to submit an electronic Final Report to CIHR and IAVI. This online report will be made available to the Nominated Principal Applicant on ResearchNet at the beginning of the grant funding period and can be filled in as the research progresses.
• Funding recipients will provide joint annual progress reports to IAVI and CIHR at the beginning of May each year in a format set by CIHR and approved by IAVI. CIHR will share the Research Reporting System data that may be generated through this FO with IAVI.
• The Nominated Principal Investigator will be required to contribute to the monitoring, review and evaluation of CIHR’s programs, policies and processes by participating in evaluation studies, surveys, workshops, audits and providing data or reports as required for the purpose of collecting information to assess progress and results.
• The Nominated Principal Investigator will be required to encourage their associates, trainees and administration to participate in the monitoring, review and evaluation of CIHR’s programs, policies and processes as required.

Review Process and Evaluation

Review Committee

A CIHR review committee will evaluate the full applications. The committee may be drawn from one of CIHR’s pre-existing committees or may be created specifically for this funding opportunity. Committee members are selected based on suggestions from many sources including the institute(s)/ branch(es) and partner(s), following the Conflict of Interest and Confidentiality Policy of the Federal Research Funding Organizations.

For information on CIHR’s peer review principles, see the Peer Review: Overview section of CIHR’s website.

Evaluation Criteria

To support the strategic objectives of this funding opportunity, the following evaluation criteria will be used.

1. Research Approach
   • Clarity of the research question.
   • Completeness of the literature review and relevance to study design/research plan.
   • Clarity of rationale for the research approach and methodology.
   • Appropriateness of the research design and methods.
   • Feasibility of the research approach (including recruitment of subjects, project timeline, preliminary data where appropriate, etc.).
   • Anticipation of difficulties that may be encountered in the research and plans for management.
   • Ability to successfully and appropriately disseminate research findings, as demonstrated by knowledge translation activities (publications, conference presentations, briefings, media engagements, etc.).
   
   
2. Relevance of the Research
   • Alignment of the project with the relevant research areas described in the objectives section.
   • Potential for the creation of new knowledge to support the development of a safe, effective and globally available VSV-HIV vaccine.
   • Originality of the proposed research, in terms of the hypotheses/research questions addressed, novel technology/methodology, and/or novel applications of current technology/methodology.


3.  Applicant(s)
   • Qualifications of the applicant(s), including training, experience and independence (relative to career stage).
   • Experience of the applicant(s) in the proposed area of research and with the proposed methodology.
   • Expertise of the applicant(s), as demonstrated by scientific productivity over the past five years (publications, books, grants held, etc.). Productivity should be considered in the context of the norms for the research area, applicant experience and total research funding of the applicant.
   • Appropriateness of the team of applicants (if more than one applicant) to carry out the proposed research, in terms of complementarity of expertise and synergistic potential.


4. Environment for the Research
   • Availability and accessibility of personnel, facilities and infrastructure required to conduct the research.
   • Suitability of the environment to conduct the proposed research.
   • Suitability of the environment (milieu, project and mentors) for the training of personnel.
   • Suitability of the capacity building plan for Canadian trainees.


5. Budget
   • Extent to which the budget is appropriate and justified in relation to the proposed activities.

Funding Decision

Upon completion of peer review, the CIHR HIV/AIDS Research Initiative and IAVI will receive the ranking list, ratings and recommendations on funding level and award term for the applications that fall in the fundable range and have been determined to be relevant to the specific research areas and objectives of the initiative. The list will be used for funding decision-making purposes and will remain anonymous unless applicants have provided written consent to share nominative information.

Applications will be funded from the top down in order of ranking as far as the budget will allow.

Applications that receive a rating below 3.5 will not be funded.

How to Apply

Important: Please read all instructions to familiarize yourself with the application process before applying. For new applicants or for those wanting a reminder of the main application procedures, an overview of CIHR's application processes can be found under Application Process. Note that these are general instructions only as the specific application instructions for this funding opportunity are located below.

• The application process for this funding opportunity is comprised of one step: Application.
• To complete your Application, follow the instructions in the Grants - ResearchNet "Application" Phase Instructions Checklist along with any additional instructions found below under “Specific Instructions”.
• Reminder to applicants: Please ensure that your application is complete (includes all required signatures) and is submitted on time to CIHR.

Submission Requirements

• Your Application must be submitted using ResearchNet. Scan and upload the signed signature pages including the routing slip in the Print/Upload Signature Pages task in ResearchNet prior to submitting your application.

Specific Instructions

Application:

Task: Identify Participants

• List all participants in this task
• For each participant (except collaborators), enter the confirmation number for the CIHR Academic CV or the Knowledge User CV, as appropriate, validated for CIHR provided by the Canadian Common CV.

Task: Enter Proposal Information

• Research Proposal (13 pages, not including references). The Research Proposal should clearly address each of the elements in the evaluation criteria.
• References (references, tables, charts, figures, photographs, questionnaires, etc.) can be uploaded under "Attachments – Research Proposal Appendix".

Task: Complete Summary of Research Proposal

• Summarize your research proposal. Note that your summary cannot exceed one page.

Task: Enter Budget Information

• Complete the budget information and clearly justify all budget items
• Funds to support annual travel to an international research meeting on HIV vaccine to participate in a research exchange meeting must be included.

Task: Attach Other Application Materials

• Upload these documents as "Other"
• Letters of Collaboration (if applicable):
  • Letter of collaboration from IAVI.
  • Signed letters of Collaboration are required from all collaborator(s) listed as Collaborators on the application.
• Letters of Support (if applicable):
  • Signed letters of Support are required from all organization(s) listed as partners on the application.
• Publications (optional):
  • A maximum of 5 publications from the past five years relevant to this proposal can be appended.

Task: Print, Scan and Upload Signature Pages

• Required signatures:
  • Signatures must be included for all applicants (except Collaborators), and individual(s) with signing authority from the Institution Paid.
  • Original signatures are not required. The scanned signed signature pages and the Routing Slip must be uploaded in the Print/Upload Signature Pages task in ResearchNet prior to submitting your application.

Contact Information

For all inquiries please contact:

CIHR Contact Center
Telephone: 613-954-1968
Toll Free: 1-888-603-4178
Email: support@cihr-irsc.gc.ca

For questions on the IAVI program and its resources, please contact:

IAVI Inc.
Beth Rasmussen
Director, Research Project Management
125 Broad Street, 9th Floor
New York, NY 10004
Tel: 212-847-1058
Email: BRasmussen@iavi.org

Sponsor Description

Partners

International AIDS Vaccine Initiative Inc (IAVI)
IAVI is a global not-for-profit, public-private partnership whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI researches and develops vaccine candidates, conducts policy analyses, and serves as an advocate for the field with offices in the US, Africa, India, and Europe. IAVI supports a comprehensive approach to HIV and AIDS that balances the expansion and strengthening of existing HIV prevention and treatment programs with targeted investments in new AIDS prevention technologies. IAVI advances its mission by leveraging a scientific network of over 100 institutional and public-private partners in the HIV vaccine field, including African research institutions, universities, governments, community-based civil society organizations, biotechnology and pharmaceutical companies

Internal Collaborators

Canadian Institutes of Health Research
At the Canadian Institutes of Health Research (CIHR), we know that research has the power to change lives. As Canada’s health research investment agency, we collaborate with partners and researchers to support the discoveries and innovations that improve our health and strengthen our health care system.

CIHR – HIV/AIDS Research Initiative
Under the leadership of the CIHR Institute of Infection and Immunity, the CIHR HIV/AIDS Research Initiative is responsible for the management and oversight of the research components of two major Government of Canada initiatives in HIV/AIDS, namely the: Federal Initiative to Address HIV/AIDS in Canada and the Canadian HIV Vaccine Initiative. This Initiative promotes Canadian research and builds research capacity in order to increase our understanding of the virus, the epidemic and effective responses.

Additional Information

Røttingen et al. Online July 31, 2015 http://dx.doi.org/10.1016/S0140-6736(15)61117-5