Solicitation Now Open!
Targeting and eliciting mucosal immunity to better protect from respiratory pathogens
Most respiratory disease vaccines are delivered through the intramuscular (IM) route, providing systemic protection but not at the site of pathogen entry (nose, mouth and lungs), making them sub-optimal. Because the natural defenses that occur at these mucosal surfaces (mucosal immunity) are not strongly elicited, breakthrough infection and transmission can still occur, creating a need for more efficacious and durable mucosal vaccines.
Context and Background
The Mucosal Immunity Innovation (MucInn) program aims to accelerate the development of innovative mucosal vaccine formulations, delivery technologies, adjuvants, and enabling platforms that enhance vaccine protection at mucosal surfaces where many respiratory infections begin.
As part of BARDA DRIVe’s MucInn Program, this funding opportunity focuses on preclinical vaccine candidate development that can overcome fundamental biological and engineering barriers limiting effective mucosal vaccination and will advance technologies towards clinical development.
BARDA and VITAL seek innovative mucosal vaccine approaches for influenza. The program will support preclinical evaluation of vaccine technologies focused on eliciting a robust, durable, and protective mucosal and systemic immune response. Proposed vaccine technologies may include innovations in: novel formulations, delivery systems, mucosal adjuvants, antigen-adjuvant co-delivery, and enabling/integrated platform technologies. Although influenza is the initial use case, these platform technologies should be translatable to other respiratory pathogens.
Specifically, technologies and proposals will need to demonstrate ability to:
Next Generation Influenza Vaccines to Improve Protection at Mucosal Surfaces
Funding Guidelines and Duration
Note: mRNA-based vaccine approaches are out of scope for this funding opportunity.
Driving Development of Innovative Vaccine Technologies to Improve Protection at Mucosal Surfaces
MucInn encourages multidisciplinary teams.
If you or your organization would like to explore collaborations with other potential applicants, please visit our MucInn Teaming Page.
Tuesday, September 15 at 2 PM ET | Virtual
Join VITAL for a live info session on the Mucosal Immunity Innovation (MucInn) program. We’ll walk through program scope, applicant eligibility, funding structure, and evaluation criteria with time for live Q&A with the VITAL team. Ideal for biotech innovators, entrepreneurs, and researchers advancing vaccine protection at mucosal surfaces, with an initial focus on influenza.
MucInn aims to accelerate the development of next generation mucosal vaccines with the initial focus on influenza with innovations in novel formulations, delivery systems, adjuvants, and enabling platform technologies that can overcome barriers to effective vaccination via mucosal surfaces and generate robust and durable local and systemic immune responses.
MucInn is interested in technologies that improve one or more of the following:
The primary pathogen of interest is influenza.
However, it is preferred that the enabling technologies developed under MucInn have the potential to be adapted for other respiratory pathogens in the future.
Any vaccine technology (with the exclusion of nucleic acid vaccines) are relevant to this funding opportunity. Ideally, the program is focused on technologies that have already been established as influenza vaccine antigens, including, but not limited to:
Applicants should clearly justify their antigen selection and explain how their approach improves mucosal immune responses against influenza.
Yes. Proposals may focus on:
Establishing collaborative teams that combine complementary expertise is strongly encouraged.
No. mRNA-based and nucleic acid-based vaccine approaches are not within the scope of this funding opportunity.
Applicants should provide sufficient preliminary data, experimental evidence or literature justification to demonstrate technical feasibility and the scientific rationale for the proposed technology. Preliminary in vitro, in vivo, or proof of concept data will strengthen the application. For example, a developer with delayed release technology with no prior vaccine development experience should present data they have on delayed release of biological products to support why it might work for vaccines. The main objective of the program is intended to support technologies that have progressed beyond early conceptual ideas and are ready for translational development.
Technologies originally developed for other vaccine candidates or even non-vaccine applications may be eligible if they can be adapted to improve mucosal vaccination against influenza and have strong scientific rationale and experimental evidence.
MucInn welcomes innovative technologies from adjacent fields, including drug delivery, biomaterials, nanotechnology, biologics, immunology, and pharmaceutical formulation, provided there is a compelling rationale for application to mucosal influenza vaccines. We strongly encourage collaborative teaming with vaccine/antigen developers, adjuvant developers, immunologists, and manufacturing experts that can combine complementary expertise and thereby strengthen their proposal.
One of MucInn’s goals is to identify innovative technologies from adjacent fields that can be adapted to improve mucosal vaccination. If your platform can enhance antigen delivery, overcome mucosal barriers, improve immune responses, or increase translational readiness, we encourage you to explore its application to influenza vaccines. To meet the objectives of MucInn, we strongly encourage collaborative teaming with vaccine/antigen developers, adjuvant developers, drug delivery and formulation developers, immunologists, and manufacturing experts that can combine complementary expertise to meet the objectives of MucInn.
The program is focused on preclinical, translational-stage technologies that ideally have demonstrated proof of concept. For MucInn, the offeror should be ready for further optimization and preclinical evaluation to inform future product development. At the end of the project, the awardee should generate sufficient data demonstrating the feasibility and translational potential to support further development of the vaccine candidate toward an IND-enabling program and future clinical development. Expected project milestones are outlined in the program solicitation.
Eligible applicants may include:
Applications that primarily focus on:
MucInn strongly encourages multidisciplinary teams that bring together complementary expertise, including antigen developers, adjuvant developers, formulation developers/technologies, drug delivery technology developers, immunologists, and manufacturing experts. These collaborative efforts maximize the likelihood of success and will greatly strengthen the proposal.
VITAL will facilitate and provide opportunities for interested organizations to connect and explore potential teaming arrangements prior to proposal submission. To submit your information for the Teaming request, please visit the MucInn Teaming Page.
Applicants may request up to $2.5M in total funding; total cost of the project could be higher if the applicant proposes cost-share.
The anticipated period of performance (POP) is approximately 24 months.
Successful projects are expected to advance innovative technologies and demonstrate measurable improvements as noted below:
In early August, BARDA launched the Single Shield Prize competition (https://www.singleshieldprize.com/). The goal of the competition is to advance the development of recombinant hemagglutinin (rHA) protein or inactivated virus vaccines for pandemic influenza H5N1 that are able to elicit robust and durable responses following a single administration. Furthermore, the proposed vaccine candidates for the Single Shield Prize must only be administered systemically/parenterally by the following methods: intramuscular, intradermal, transdermal, subcutaneous. The focus is on advancing innovations to provide protection with single administration for established influenza vaccine platforms. By contrast, the MucInn program is focused on innovations that enhance protection at mucosal surfaces where many respiratory infections begin. The program seeks novel formulations, delivery systems, adjuvants, and enabling platform technologies that are specifically tailored toward mucosal vaccines administered via intranasal, oral, sublingual, or related mucosal-associated routes of delivery.
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.
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:
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.
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.
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
Overcoming Barriers Within the Mucosa
MucInn focuses on high-impact translational vaccine technologies across four core development activities.
Novel Formulations
Protection at the primary site of infection:
Defends the body at the exact point where pathogens first enter.
MucInn is structured around four program goals.
Demonstrate ability to elicit robust, durable, and broadly protective immune responses at mucosal sites and improvement over standard of care.
