Viral INfections in the Young Lung- The VINYL Clinical Consortium (UG3/UH3 Clinical Trial Optional) | RFA HL 26 006

Opportunity Information: Apply for RFA HL 26 006

The Viral INfections in the Young Lung (VINYL) Clinical Consortium funding opportunity (RFA-HL-26-006) is an NIH cooperative agreement designed to build and run a multi-site clinical research network focused on severe viral lower respiratory tract infections in very young children. The central goal is to enroll and deeply characterize 1,500 babies, infants, and toddlers from birth through 2 years of age who are hospitalized with viral LRTI, specifically cases presenting as acute bronchiolitis, pneumonia, and/or pediatric acute respiratory distress syndrome (PARDS). Alongside the in-hospital work, the program requires longitudinal follow-up so researchers can determine how these early-life infections shape later lung health, with a major emphasis on identifying evidence of asthma and other lung disease outcomes when children reach 4 to 5 years of age.

The scientific rationale is tied to the fact that bronchiolitis is both common and uniquely tied to the immature biology of the young lung, making it the leading cause of hospitalization for viral LRTI in children ages 0 to 2, including those born preterm. Despite how frequently clinicians see bronchiolitis and related viral LRTIs, the opportunity highlights major gaps: inconsistent definitions and diagnostic approaches, limited ability to predict which children will worsen or require intensive care, and an incomplete understanding of why some children are hospitalized while others recover at home. It also points to a key biological uncertainty, namely how an immature respiratory immune system responds to viral infection, how those responses differ across viruses, and how heterogeneity in host response may explain the wide range of disease severity. On the clinical side, the announcement emphasizes that current interventions and management practices vary substantially between institutions, and that this practice variation may influence near-term outcomes during hospitalization as well as long-term respiratory health.

To address these issues, VINYL is structured as a pragmatic observational consortium. In practice, that means participating clinical sites will recruit eligible hospitalized children and conduct deep phenotyping during the acute illness. While the announcement does not list every assay or measurement in the provided text, the intent of deep phenotyping is clear: gather rich clinical, biological, and other patient-level data that can be used to (1) define clinically meaningful subgroups, (2) improve or refine how viral LRTI syndromes like bronchiolitis are diagnosed and described, (3) better understand drivers of severity and the need for hospitalization or ICU-level care, and (4) discover prognostic biomarkers that can predict later airway and lung parenchymal disease. The expectation is that, by harmonizing data collection across a consortium and enrolling a large cohort, the program will be able to move beyond single-center findings and produce results that are more generalizable and clinically useful.

A major deliverable is the follow-up phase after discharge. VINYL plans to track participants using electronic health records and questionnaires, and to directly assess respiratory status around ages 4 to 5 to clarify longer-term pulmonary outcomes from early viral LRTI, especially asthma. The follow-up is not limited to the lungs: the consortium will also evaluate neurocognitive development, general development, and sleep over time. This reflects a broader view that severe early-life respiratory infections and hospitalization may have wider impacts on child health and functioning, and that understanding those trajectories could inform both clinical care and future prevention strategies.

From an administrative standpoint, this is a discretionary NIH opportunity using a cooperative agreement mechanism (UG3/UH3) with clinical trial optional language, under the health-related CFDA listing 93.838. The cooperative agreement format generally signals substantial NIH involvement in coordination, milestones, and consortium-wide governance, which fits a multi-site effort that needs common protocols, standardized data elements, and shared plans for biospecimens, analysis, and follow-up. The UG3/UH3 structure typically supports a phased approach, where early activities focus on startup and readiness (for example, finalizing protocols, data systems, recruitment workflows, and site harmonization) followed by an implementation phase once milestones are met, though the specific milestone framework would be detailed in the full solicitation.

Eligibility is broad across U.S. organizational types. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses, among others. The announcement also notes additional eligible applicants such as eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign organizations (non-U.S. entities) are not eligible to apply as applicants, but non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by NIH policy.

Key dates provided include a creation date of 2025-09-18 and an original closing date of 2025-11-10. Overall, the opportunity is aimed at building a coordinated, real-world hospital-based cohort that can link what happens during an acute viral LRTI admission in the first two years of life with measurable respiratory and developmental outcomes several years later, while also creating a platform for identifying biologically and clinically meaningful subgroups and predictors that could eventually improve diagnosis, risk stratification, and management.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Viral INfections in the Young Lung- The VINYL Clinical Consortium (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
• This funding opportunity was created on 2025-09-18.
• Applicants must submit their applications by 2025-11-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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