Notice of Intent to Publish a Funding Opportunity Announcement for Martin Delaney Collaboratories for HIV Cure Research (UM1 Clinical Trial Not Allowed)

Notice Number: NOT-AI-20-032

Key Dates
Release Date: February 10, 2020
Estimated Publication Date of Funding Opportunity Announcement: June 16, 2020
First Estimated Application Due Date: December 07, 2020
Earliest Estimated Award Date: June 07, 2021
Earliest Estimated Start Date: July 01, 2021

Related Announcements
RFA-AI-15-029

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) intend to publish Funding Opportunity Announcements (FOAs) for the Martin Delaney Collaboratories (MDC) for HIV Cure Research program, a cooperative partnership between academia, industry, government, and community aimed at developing innovative strategies for cure or sustained remission of persistent HIV infection (https://www.niaid.nih.gov/research/mdc). Two separate FOAs will be issued: one will be a re-issue of the Martin Delaney Collaboratories for HIV Cure Research (UM1) FOA, and the other will be a new FOA for an MDC focused specifically on HIV cure research in pediatric populations. Only new applications will be accepted under both FOAs; competitive renewal applications from existing awards will not be accepted.

This Notice is being issued to allow potential applicants more time to consider the requirements of this program and to develop responsive projects.

Research Initiative Details

Applications will include both basic and applied (preclinical) research. Some aspect of clinical research must be included, however clinical trials will not be allowed in either FOA. Applicants will be encouraged to develop clinical trial protocols within the Collaboratory and to seek separate funding for implementation of the trials through NIAID HIV/AIDS Clinical Trial Networks, U01 grant applications, industry sponsorship, or support from other funding organizations.

Each application will include at least one private sector partner that contributes materially and intellectually to the Collaboratory. Applications will also include at least one Community Partner to facilitate community engagement activities. Community Partners may include community advocates, non-government organizations, non-profit organizations, and/or community-based organizations. The Community Partner(s) will be distinct and separate from a Community Advisory Board (CAB), which will also be required. A Community Engagement Coordinator (CEC) will be required and may or may not serve as a Community Partner, depending on their affiliation and role. Both private sector and community partners may be listed on more than one application. Applicants should not solicit CAB or Scientific Advisory Board (SAB) members prior to award.

NIAID intends to fund 4-6 awards under the re-issued MDC FOA and one award under the new Pediatric MDC FOA. NIAID intends to cap direct costs at $3.5 million per year for each award. Institutional support will be highly encouraged. Collaboratories funded under either FOA will be expected to work together with the other Collaboratories to share research progress, develop collaborative projects, share best practices, and avoid research overlap.

Objectives and Scope

For both FOAs, Collaboratories will need to address three different, but interconnected, pathways of research within a single, complex research project. Each overall research plan will include three common Research Foci:

  • Research Focus 1 – Basic Research will need to outline plans to identify, characterize, and quantify persistent viral reservoirs and mechanisms of persistence using cutting-edge technologies, determine the sources of viral rebound, and/or determine the mechanisms of post-treatment control of viremia.
  • Research Focus 2 – Control of Rebound will need to outline the development and testing of therapeutic strategies to achieve a sustained, durable viral remission either through induced immunologic control of viral rebound or sustained expression of therapeutics. The proposed strategies should provide a clear advantage over long-acting ART delivery strategies currently under development.
  • Research Focus 3 – Eradication (or Inactivation) will need to focus on the goal of reducing the size of the rebound-competent reservoir, with an ultimate goal of achieving a “classical” cure. Proposed approaches could either focus on elimination/clearance of cellular reservoirs or permanent inactivation of rebound-competent provirus (e.g. using gene modification).

For the pediatric MDC FOA only, the Collaboratory will also need to specifically address the development of innovative assays and tools to facilitate HIV persistence research and the testing of curative strategies in pediatric populations in a fourth Research Focus:

  • Research Focus 4 – Assay and Tools Development will focus on the goal of developing/optimizing assays, tools and imaging modalities adapted to pediatric populations to characterize and accurately quantify rebound-competent reservoirs in clinical samples or in suitable animal models.

Eligibility

A Program Director/Principal Investigator (PD/PI) may NOT apply to both the parent MDC and pediatric MDC program FOAs. Only one application per institution will be allowed; however, institutions may receive funding from multiple awards through sub-awards. Investigators may be listed on more than one application, as long as their projects are not overlapping.

Foreign (non-US) applications will NOT be permitted, but foreign components will be allowed for both FOAs.

Funding Information
Estimated Total Funding : TBD
Expected Number of Awards: NIAID intends to fund 4-6 awards under the re-issued MDC FOA and one award under the new Pediatric MDC FOA.
Estimated Award Ceiling: NIAID intends to cap direct costs at $3.5 million per year for each award.
Primary CFDA Numbers: 93.855

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Karl Salzwedel, PhD
National Institute of Allergy and Infectious Disease (NIAID)
301-496-5332
karl.salzwedel@nih.gov

For inquiries specifically related to the pediatric MDC FOA:

Tania B. Lombo, PhD
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-761-7612
Email: tania.lombo@nih.gov