Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is offering funding through the opportunity titled "Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Disease (R01 Clinical Trial Not Allowed)." This initiative focuses on supporting preclinical research aimed at developing vaccines to prevent infection and disease caused by Mycobacterium tuberculosis (Mtb). The effort aligns with NIAID's Strategic Priority 4 as outlined in its 2024 Strategic Plan for Tuberculosis Research, underscoring the agency's commitment to advancing vaccine development against tuberculosis (TB). This funding opportunity is intended to address the increasing global and domestic TB burden. With over 1.25 million global deaths and rising infection rates in the United States, particularly drug-resistant forms of TB, the need for new and effective vaccines is urgent. The only currently licensed vaccine, Bacillus Calmette-Guérin (BCG), provides limited protection primarily in infants and fails to adequately protect adolescents and adults—the major spreaders of TB. Moreover, the global vaccine development pipeline lacks sufficient early-stage candidates, threatening long-term TB control efforts. Applicants may propose projects focused on the preclinical development of lead vaccine candidates that have already demonstrated proof-of-concept efficacy and immunogenicity in relevant models. The definition of a lead vaccine candidate includes a selected antigen, adjuvant, and delivery platform intended for eventual clinical application. Proposed activities can include optimizing candidate vaccines, conducting safety and efficacy testing in challenge models, manufacturing under GMP or GLP conditions, performing IND-enabling studies, and developing robust production processes that can improve vaccine stability and delivery logistics. A unique requirement of this NOFO is the mandatory participation of at least one industrial partner, defined as a pharmaceutical, biotech, or similar entity with a proven track record in product development. These partners must provide substantive investment, such as in-kind contributions, technical support, or infrastructure enhancements. Applications led by academic institutions must include such a partner, or they will be deemed nonresponsive. Conversely, industrial organizations may apply independently. The funding opportunity offers a total of approximately $4.73 million in Fiscal Year 2026, with plans to fund four to five projects. Individual applications should not exceed $750,000 in direct costs per year and can span up to five years, depending on the project scope. Clinical trials are not permitted under this announcement. Applications must be submitted electronically through NIH’s ASSIST system, institutional S2S systems, or Grants.gov Workspace. All applicants must ensure they meet required federal registration guidelines, including having a Unique Entity Identifier and active accounts with SAM.gov and eRA Commons. The application window opens on October 7, 2025, and the final deadline is November 7, 2025, by 5:00 PM local time. A Letter of Intent is requested by October 8, 2025, which is 30 days before the full application deadline. Scientific merit reviews will occur in March 2026, followed by advisory council review in May 2026, with award announcements expected by July 2026. For further assistance, scientific/research inquiries can be directed to Dr. Katrin Eichelberg at keichelberg@nih.gov or 240-669-2921, while financial matters may be addressed with Marclyne Ceron at marclyne.ceron@nih.gov or 301-761-7993.

Follow NIH ASSIST or Grants.gov submission instructions exactly; do not deviate from the Application Guide; include mandatory Product Development Strategy attachment or risk disqualification.