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Mucosal Immunity Innovation –  MucInn

Driving Development of Innovative Vaccine Technologies to Improve Protection at Mucosal Surfaces

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Many respiratory pathogens, including influenza viruses, initiate infection at mucosal surfaces of the upper respiratory tract. While conventional vaccines can provide protection against severe disease, they often generate limited and short-lived immune responses at the site of infection, leaving opportunities for breakthrough infection and onward transmission.

What is MucInn?

The Mucosal Immunity Innovation (MucInn) program aims to accelerate the development of innovative vaccine technologies and candidates that enhance vaccine protection at mucosal surfaces, including the nose and airways, where many respiratory infections begin.

MucInn focuses on high-impact translational vaccine innovations with an initial focus on pre-clinical development, aiming to improve the performance, durability, and translational readiness of mucosal targeted vaccines.

MucInn seeks to develop novel vaccine technologies and formulations that:

  • Effectively deliver and penetrate across mucosal surfaces
  • Overcome mucosal clearance mechanisms, poor antigen uptake, and local immune tolerance
  • Elicit robust, durable and protective immune responses at mucosal sites
  • Induce both local mucosal and systemic immune protection

Initial Focus: Influenza

The program’s initial focus is influenza. MucInn is designed as a force multiplier; by advancing enabling platform technologies, the program aims to establish platform capabilities that can be applied to a broad range of respiratory pathogens, to specifically enhance mucosal vaccine durability and strengthen preparedness for future outbreaks.

Development Stage

The focus is on pre-clinical development.
Program Mandate
Aligned with BARDA’s mission to improve mucosal vaccine performance and translational readiness. mRNA-based approaches are not considered to be in-scope for this opportunity.
Initial Focus: Pandemic Influenza
The program’s initial focus is pandemic influenza. MucInn is designed as a force multiplier; by advancing enabling platform technologies, the program aims to establish platform capabilities that can be applied to a broad range of respiratory pathogens, to specifically enhance mucosal vaccine durability and strengthen preparedness for future outbreaks and pandemics.

The focus is on pre-clinical development.

Aligned with BARDA’s mission to improve mucosal vaccine performance and translational readiness. m-RNA-based approaches are not considered to be in-scope for this opportunity.

Why Mucosal Immunity Matters

Intramuscular Vaccines Have a Gap

Most respiratory disease vaccines are delivered through the intramuscular (IM) route, providing systemic protection but not at the site of pathogen entry, making them sub-optimal.

Mucosal Vaccines Offer Greater Potential

Mucosal vaccines have the potential to reduce infection and transmission while preventing severe disease and mortality, by eliciting robust and durable mucosal and systemic immune responses.

Overcoming Barriers Within the Mucosa

Novel formulations must penetrate mucosal surfaces, overcome nonspecific tolerance responses and clearance, and elicit robust and durable immune responses both systemically and locally.

Focus Areas

MucInn focuses on high-impact translational vaccine technologies across four core development activities.

Novel Formulations

Identify and advance novel formulations that improve antigen stability, delivery, and mucosal penetration.
Delivery Technology Evaluation
Evaluate delivery technologies to mucosal surfaces, including intranasal, aerosolized systems, or oral administration, in relevant preclinical models.
Mucosal Adjuvants
Identify and assess co-administration of mucosal adjuvants that enhance localized and systemic immunity.
Preclinical Evidence Generation
Support preclinical evidence generation to enable successful transition into clinical development.

Benefits of Targeted Mucosal Immunity

This targeted vaccine approach to elicit mucosal immunity delivers a number of advantages for disease prevention.

Protection at the primary site of infection:

Defends the body at the exact point where pathogens first enter.

Potential to reduce likelihood of transmission:
Mucosal immunity may limit both infection and onward spread within populations.
Reduced requirement for needles and syringes:
Needle-free delivery formats improve patient compliance and broaden access.
Ease of vaccine administration:
Simpler delivery routes enable more flexible deployment in a range of settings.

Four Goals Driving MucInn

MucInn is structured around four program goals.

1. Novel Formulations and Delivery Strategies
Develop novel vaccine formulations and delivery strategies that specifically address challenges in eliciting mucosal immunity.
2. Robust, Durable Immune Responses

Demonstrate ability to elicit robust, durable, and broadly protective immune responses at mucosal sites and improvement over standard of care.

3. Enhanced Immunological Understanding
Enhance understanding of local and systemic immune response to mucosal vaccines.
4. Modular, Extensible Vaccine Approaches
Identify modular vaccine approaches that can be leveraged for other respiratory pathogens beyond the initial influenza focus.

MucInn as a Force Multiplier

While MucInn’s initial focus is influenza, the program is designed as a force multiplier, enabling platform technologies in formulations, delivery, and adjuvants that can be applied to a broad range of respiratory pathogens to enhance mucosal vaccine durability. The modular vaccine approaches developed through MucInn are intended be leveraged across BARDA’s threat space, with each advance in formulation, delivery, or adjuvant science representing a reusable building block for future vaccine programs.
Influenza (Initial Focus) Respiratory Pathogens Pandemic Preparedness Emerging Infectious Diseases BARDA Threat Space

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