Viral INfections in the Young Lung- The VINYL Clinical Consortium (UG3/UH3 Clinical Trial Optional)

The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has released a funding opportunity titled “Viral Infections in the Young Lung – The VINYL Clinical Consortium (UG3/UH3 Clinical Trial Optional).” This initiative is part of a broader strategy to advance research in pediatric lung health, specifically focusing on viral lower respiratory tract infections (LRTI) in children aged 0–2 years, including those born preterm. These infections, such as bronchiolitis, pneumonia, and pediatric acute respiratory distress syndrome (PARDS), remain the leading cause of hospitalization among young children. Despite their prevalence, there are significant knowledge gaps in understanding disease heterogeneity, severity predictors, immune responses, and long-term pulmonary consequences. To address these gaps, the VINYL Consortium will create the largest multi-dimensional and publicly accessible cohort and biorepository of young children hospitalized for viral LRTI in the U.S. The program will establish a Clinical Coordinating Center (CCC) with one embedded Clinical Center (CC), four additional CCs, and one centralized Biorepository, awarded through a phased UG3/UH3 cooperative agreement. The first year (UG3 phase) will support protocol development, regulatory approvals, and site activation, with a goal of enrolling the first patient within 12 months. Upon meeting milestones, the UH3 phase will fund up to six additional years of longitudinal studies, including hybrid follow-up visits 6 months post-discharge and comprehensive assessments at ages 4–5. The consortium aims to enroll 1500 children over three years, with at least 1200 retained through final follow-up. Investigators must also propose 2–4 mechanistic studies (Basic Experimental Studies in Humans, BESH) to deepen understanding of viral LRTI pathobiology and treatment responses. The CCC will lead development of the common protocol, oversee enrollment and biospecimen collection, ensure data quality, and provide sub-awards to the CCs and Biorepository. The Biorepository will manage centralized biosample processing, storage, and distribution, linking data and biospecimens with the Data and Analytics Coordinating Center (DACC, funded under a companion NOFO). Together, these resources will generate accessible data and biospecimens to advance research across the pediatric and pulmonary research communities. The NHLBI will maintain oversight through a Steering Committee, an independent Data and Safety Monitoring Board (DSMB), and an external Advisory Board. Applications will be reviewed based on the importance of the research, rigor and feasibility, and investigator expertise and resources. Reviewers will evaluate the ability to achieve adequate enrollment, maintain longitudinal follow-up, and deliver reproducible findings of clinical and mechanistic relevance. Applicants must also demonstrate capacity in biospecimen collection, pediatric pulmonary and critical care research, and data sharing. Specific review criteria include the strength of the proposed scientific projects, appropriateness of the cohort design, inclusion of diverse populations, and commitment to open data and biospecimen access. Eligible applicants include higher education institutions, nonprofit and for-profit organizations, tribal governments, school districts, local and state governments, and certain federal agencies. Foreign organizations are not eligible to apply, and NIH’s 2025 policy prohibits foreign subawards or subcontracts under this NOFO, though unfunded collaborations and procurement from foreign vendors are permitted. Multi-PI applications are encouraged, provided a strong leadership plan is included. No cost sharing is required. Applications must be submitted electronically via ASSIST, Grants.gov, or institutional system-to-system solutions by November 10, 2025, with earliest funding start dates in July 2026. The NOFO does not require a Letter of Intent. Required attachments include clinical center research capability, consenting procedures, a cohort retention plan, organizational plan, mechanistic study details, and a consortium-wide protocol budget. Budgets must include per-patient costs for recruitment, biospecimen processing, data collection, personnel, and protocol-driven procedures, with capitation-based sub-awards to CCs. The UG3 phase allows up to $1.64 million in direct costs, followed by progressively higher allocations in UH3 years two through seven, totaling up to $27.1 million in direct costs over the award period. Scientific contact for this opportunity is Dr. Marrah Lachowicz-Scroggins (marrah.lachowicz-scroggins@nih.gov, 301-827-8229). Financial and grants management inquiries may be directed to NHLBI’s Office of Grants Management (NHLBIOGMInbox@nhlbi.nih.gov). Peer review coordination will be managed by the NIH Center for Scientific Review (NOFOReviewContact@csr.nih.gov). The opportunity is cataloged under Assistance Listing Number 93.838, with the funding announcement identifier RFA-HL-26-006. The NOFO will expire November 11, 2025.