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Highlighted Topic: Using Clinical Studies and Human-Based Models to Understand Vaccine Mechanisms Impacting Efficacy and Safety

National Institutes of Health

Vaccines are important public health interventions to reduce infectious disease incidence, severity and mortality. Understanding the biological mechanisms underlying vaccine efficacy, safety, non-target effects, and susceptibility to adverse events remains a central challenge. Traditional animal models are limited in their ability to capture human-specific pathways, susceptibility factors, long-term health effects, and immunological and developmental context. In addition, existing post-market surveillance systems face significant limitations in mechanistic understanding, as they generally capture disease outcomes without exploring biomarkers that may illuminate mechanistic pathways.

Both experimental approaches using human-based systems and observational studies in human participants can be used to explore the mechanistic pathways between vaccines and beneficial and adverse outcomes across the general population or specific subgroups.

Recent advances in New Approach Methodologies (NAMs), including human cell-based systems, organoids, microphysiological systems, biomarkers, and computational models, offer unprecedented opportunities to generate subpopulation-specific safety profiles and mechanistic data. These approaches enable direct interrogation of immune activation pathways, neuroimmune interactions, and maternal-fetal biology, as well as identification of susceptibility factors (e.g., genetic background, sex, developmental stage). Importantly, NAMs are well-suited to evaluate biological plausibility, dose-response relationships, and mechanistic coherence across systems, and can also be integrated with clinical and epidemiological data to understand patient- and population-level outcomes.

Despite these advances, NAMs have not been systematically applied to study how vaccine products, adjuvants or other component exposures and schedules may influence immune responses, neurodevelopmental processes, or affect other organ systems (non-target effects). Additionally, NAMs have not been applied to identify factors that may inform longer-term health trajectories. Integrating NAMs into a coordinated research framework is essential to move beyond descriptive associations toward causal, mechanistic understanding. Finally, biomarkers are critical tools for linking mechanistic insights from NAMs to clinical and population-level outcomes.

Apply through an appropriate NIH Parent Funding Announcement or another broad NIH opportunity available on Grants.gov .

Expiration Date: June 3, 2028

Specialties

Medical

Medical - Clinical Science

Medical - Basic Science

Medical - Translational

Eligibility Requirements

Sponsor Details

Sponsor Institute/Organizations: National Institutes of Health

Sponsor Type: Government/Federal

Address: National Institutes of Health; 31 Center Drive; MSC 2220; Bethesda; MD 20892-2220; USA

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