Non-dilutive Funding to Advance Mucosal Vaccines for Influenza
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 & 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.
Context & 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.
Context & 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.
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:
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Key Focus Areas
Key Focus Area
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.
Next Generation Influenza Vaccines to Improve Protection at Mucosal Surfaces
Preview the MucInn Proposal Pre-Submission Package and Abstract Template here
mRNA-based vaccine approaches are out of scope for this funding opportunity.
Funding Guidelines and Duration
- We are accepting applications from academic innovators, non-profit entities and for-profit startups and companies globally, interested in seeking regulatory approval, commercializing and marketing solutions
- The MucInn awards are anticipated to be multi-year awards for development activities taking approximately 2 years; however, the exact timeline for each project will be finalized during negotiations
- Applicants may request up to $2.5M in funding
- Applicants may propose larger dollar-value projects through cost sharing
- Awards will be structured as milestone-based, fixed price contracts
Advancing Solutions That Protect Public Health
BARDA primarily develops medical countermeasures to counter acute threats and does not support research and development or acceleration in the areas of oncology or chronic disease.
However, BARDA does partner with innovators and companies developing platform and multi-use technologies. Applicants can include data from other use cases so long as BARDA funding will be used to support research and development of the BARDA-relevant use cases.
Advancing Solutions That Protect Public Health
- BARDA primarily develops medical countermeasures to counter acute threats and does not support research and development or acceleration in the areas of oncology or chronic disease.
- However, BARDA does partner with innovators and companies developing platform and multi-use technologies. Applicants can include data from other use cases so long as BARDA funding will be used to support research and development of the BARDA-relevant use cases.
Timeline for MucInn Funding
Pre - Proposal Applications Due
Full Proposal Application
Full Proposal Due
Applicants advancing to the next stage will be invited to a pitch call (by Invitation only).
Awards Selection & Project Kickoff
Mucosal Immunity Innovation ( MucInn) Teaming
- Thank you for your interest in the Mucosal Immunity Innovation (MucInn) Program. MucInn is seeking to advance formulation and delivery technologies for mucosal influenza vaccines that can effectively deliver vaccines in relevant nonclinical models. Areas of interest include technologies that enhance penetration across mucosal surfaces, overcome mucosal delivery barriers, elicit robust and durable mucosal and systemic immune responses, co-deliver antigen and adjuvant, and improve translational readiness and manufacturability. Because these goals often require multidisciplinary expertise, collaborations between innovators are encouraged to strengthen potential applications.
- If you or your organization would like to explore collaborations with other potential MucInn applicants, please complete the form below. Following a brief vetting process, VITAL will contact you and, if approved, add your information to a publicly accessible teaming directory to help facilitate connections with prospective collaborators. This directory is intended to bring together organizations with complementary expertise, including mucosal vaccine development, antigen design, delivery technologies, adjuvants and formulations, influenza pathophysiology, vaccine development and regulatory strategy, manufacturing, and influenza immunogenicity and challenge studies.
Mucosal Immunity Innovation ( MucInn) Teaming
- Thank you for your interest in the Mucosal Immunity Innovation (MucInn) Program. MucInn is seeking to advance formulation and delivery technologies for mucosal influenza vaccines that can effectively deliver vaccines in relevant nonclinical models.
- Areas of interest include technologies that enhance penetration across mucosal surfaces, overcome mucosal delivery barriers, elicit robust and durable mucosal and systemic immune responses, co-deliver antigen and adjuvant, and improve translational readiness and manufacturability. Because these goals often require multidisciplinary expertise, collaborations between innovators are encouraged to strengthen potential applications.
- If you or your organization would like to explore collaborations with other potential MucInn applicants, please complete the form below. Following a brief vetting process, VITAL will contact you and, if approved, add your information to a publicly accessible teaming directory to help facilitate connections with prospective collaborators. This directory is intended to bring together organizations with complementary expertise, including mucosal vaccine development, antigen design, delivery technologies, adjuvants and formulations, influenza pathophysiology, vaccine development and regulatory strategy, manufacturing, and influenza immunogenicity and challenge studies.
Please Note
Browse profiles of organizations and researchers interested in MucInn collaboration below. Each profile includes contact information, so if you see a potential fit, reach out directly to start the conversation. VITAL does not broker individual partnerships, so we encourage you to connect with collaborators on your own.
Please note that by publishing the teaming profiles, neither VITAL nor BARDA is endorsing, sponsoring, or otherwise promoting or elevating the qualifications of the individuals or organizations included on the list. Additionally, completing the teaming form does not constitute an application for the MucInn funding opportunities, but rather, provides you an opportunity to partner and collaborate with other potential applicants to strengthen the quality of the submission. Submissions to the teaming profiles list are reviewed and updated periodically.
AuraVax Therapeutics Inc
- Biotech
- Adjuvant & immune modulation
- Mucosal adjuvants
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Battelle Biomedical Research Center
- Service Provider - CRO
- Preclinical models, immune evaluation
- Other
- Commercial
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
BIOQUAL, Inc.
- Service Provider - CRO
- Preclinical models, immune evaluation
- Delivery systems
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
Studies can be designed to assess the impact of delivery route on vaccine immunogenicity, protection, and viral replication following challenge. Comprehensive endpoints may include HAI, microneutralization, neuraminidase inhibition, ELISA, cellular immune responses, viral RNA/viral load, and clinical observations. These integrated models, delivery approaches, and analytical assays enable evaluation of route-dependent vaccine performance and provide translational data to support influenza vaccine development.
What We’re Seeking in Teaming Partners
Boost Biopharma, Inc.
- Biotech
- Antigen/Vaccine development
- Antigen-adjuvant co-delivery
- Clinical stages
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Codagenix Inc
- Biotech
- Antigen/Vaccine development
- Other
- Clinical stages
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Duke University Regional Biocontainment Laboratory
- Academic/Research Organization
- Preclinical models, immune evaluation
- Other
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Dyadic International, Inc.
- Biotech
- Antigen/Vaccine development
- Other
- Clinical stages
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
InflammaSense
- Biotech
- Antigen/Vaccine development
- Other
- Clinical stages
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Jurata Inc.
- Biotech
- Formulation technologies
- Antigen-adjuvant co-delivery
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
SeromYx Systems
- Service Provider - CRO
- Preclinical models, immune evaluation
- Other
- Clinical stages
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
TollereBio
- Biotech
- Adjuvant & immune modulation
- Mucosal adjuvants
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Transmucosis, University of Maryland
- Biotech
- Antigen/Vaccine development
- Delivery systems
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
the infection and transmission of respiratory viral infections.
What We’re Seeking in Teaming Partners
University of California, San Diego
- Academic/Research Organization
- Adjuvant & immune modulation
- Mucosal adjuvants
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
VIOLET Pharmaceuticals
- Biotech
- Adjuvant & immune modulation
- Mucosal adjuvants
- Pre-clinical
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
Wyss Institute at Harvard University
- Academic/Research Organization
- Drug delivery systems
- Controlled-release technologies
- Early development
Primary Focus of Work
Influenza Vaccine Delivery in Nonclinical Models
What We’re Seeking in Teaming Partners
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FAQs
Browse common topics below, or search for a specific question to find what you need quickly.
What is the goal of the Mucosal Immunity Innovation (MucInn) Program?
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.
What types of technologies are relevant to the MucInn program funding opportunity?
MucInn is interested in technologies that improve one or more of the following:
- Delivery across barriers of the respiratory mucosa
- Retention of vaccines on mucosal surfaces
- Antigen uptake and presentation
- Co-delivery of antigen and adjuvant
- Mucosal targeting
- Controlled or sustained antigen release
- Novel adjuvant technologies
- Bioadhesive or penetration-enhancing formulations
- Novel formulations that enhance mucosal immune response
- Platform technologies that improve manufacturability, scalability, or translational readiness of mucosal vaccines
Which pathogen is the initial focus of the program?
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.
Which influenza vaccine antigens are within scope?
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:
- Hemagglutinin (HA) containing vaccines
- Neuraminidase (NA)
- Conserved influenza antigens (e.g., M2e or other broadly protective influenza antigens)
- Combinations of influenza antigens
Applicants should clearly justify their antigen selection and explain how their approach improves mucosal immune responses against influenza.
Are both antigen and delivery technologies eligible?
Yes. Proposals may focus on:
- Novel antigen formulations
- Adjuvants
- Delivery systems
- Integrated antigen-adjuvant co-delivery platforms
- Other novel approaches
Establishing collaborative teams that combine complementary expertise is strongly encouraged. MucInn does not fund standalone adjuvant or delivery technologies. Proposals must evaluate a vaccine formulation in which the antigen is combined or co-delivered with the adjuvant and/or delivery technology as a single system. Adjuvant and delivery developers without their own antigen must partner with an antigen developer.
Are mRNA/nucleic acid vaccines within the scope of this program?
Is presentation of preliminary data required for the submission?
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. Preliminary data figures can be added to the ‘Upload Materials’ section at the end of the application.
Do I need to already have a mucosal influenza vaccine?
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.
Can companies with technologies outside of the vaccine field apply?
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.
My technology was not originally developed for vaccines. Should I still apply?
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.
Which stage of development is MucInn targeting?
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.
Who is eligible to apply?
Eligible applicants may include:
- Small and large for-profit companies
- Academic innovators
- Non-profit research organizations
- Other organizations with relevant technologies that align with the program objectives
Applicants based outside the U.S. are eligible. A U.S.-based prime applicant may also subcontract work to labs outside the U.S.
Technologies that are already licensed are also eligible, as long as the proposal directly addresses the specific objectives and scope requirements in the MucInn solicitation.
Which technologies are out of scope for MucInn?
Applications that primarily focus on:
- Vaccine candidates that utilize nucleic acid constructs (short nucleic acid oligos used as adjuvants are in scope).
- Vaccine candidates that utilize non-nasal or non-respiratory mucosal routes of administration (e.g., transdermal patch, intramuscular or subcutaneous injection). Oral delivery is acceptable with a compelling mucosal-targeting rationale, including platforms that target gut-associated mucosal immunity.
- Disease targets lacking relevance to influenza
- Technologies without supporting feasibility data are generally not considered responsive to this opportunity.
- Vaccine candidates and proposals that do not adequately describe how the design will overcome the three main challenges associated with: 1) penetrating mucosal surfaces; 2) overcoming the nonspecific tolerance responses, clearance, and poor uptake within the mucosa and increasing residence time; and 3) eliciting robust and durable immune responses – both systemically and locally.
- Influenza vaccine candidates that are already in clinical development
Which particular development efforts are out of scope for MucInn?
- Standalone antigen discovery without a delivery/formulation innovation
- Incremental reformulations lacking a clear innovation
- Standalone adjuvant or delivery technologies not combined with an antigen
- Basic discovery research without a clear translational pathway
- Basic immunology studies without a defined translational pathway
- Clinical trials or late-stage product development
Is teaming encouraged?
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.
How can I find teaming partners or potential collaborators?
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.
Individuals with relevant expertise who want to support applicant teams can also register on the Teaming Page and create a directory profile, so applicant teams can contact them directly. MucInn does not directly hire individual mentors or consultants. Developers can also review the NIAID Vaccine Adjuvant Compendium (https://vac.niaid.nih.gov/) and contact adjuvant developers directly to explore potential teaming arrangements for the MucInn program.
How much funding can I request?
Applicants may request up to $2.5M in total funding per award; total cost of the project could be higher if the applicant proposes cost-share.
The cap applies to each individual award, not to the program as a whole. The exact number of awards has not been predetermined.
Indirect costs (overhead) are allowable, including a university’s standard indirect cost rate. All direct and indirect costs must fit within the $2.5M cap for the 24-month period of performance.
What is the anticipated period of performance?
The anticipated period of performance (POP) is approximately 24 months.
What outcomes of the MucInn program would be deemed successful?
Successful projects are expected to advance innovative technologies and demonstrate measurable improvements as noted below:
- Enhanced mucosal immune responses
- Improved antigen delivery or uptake
- Increased durability of immune protection
- Improved local and systemic immunity
- Improved translational readiness of technology
- Enable future development of next-generation influenza vaccines
BARDA recently announced a prize competition to develop single administration pandemic influenza vaccines. How does the prize competition differ from the MucInn program?
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.
What animal model is required for efficacy studies?
Ferrets are the required efficacy model. Additional animal models may be used to supplement the ferret data, provided the applicant explicitly justifies the choice of model, explains how it mirrors human-relevant mucosal immunity to influenza, and describes how the data will translate to or de-risk the required ferret efficacy studies.
Applicants without access to a ferret model are highly encouraged to team with partners who have this capability. Visit the MucInn Teaming page to find collaborators.