Applications Open

Mucosal Immunity Innovation (MucInn) Program

Targeting and Eliciting Mucosal Immunity to Better Protect from Respiratory Pathogens

Preview the MucInn Proposal Pre-Submission Package and Abstract Template here

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Request a Market Research Call with VITAL and BARDA to showcase and determine scope fit of your work.

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:

1.

Effectively deliver and facilitate penetration across mucosal surfaces

2.

Overcome key mucosal clearance mechanisms, poor antigen uptake, and local immune tolerance

3.

Elicit robust, durable, and protective immune responses at mucosal sites

4.

Include both local mucosal and systemic immune protection

5.

Co-deliver antigen and adjuvant

6.

Improve translational readiness and manufacturability

Key Focus Areas

Next Generation Influenza Vaccines to Improve Protection at Mucosal Surfaces

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

Note

mRNA-based vaccine approaches are out of scope for this funding opportunity.

Funding Guidelines and Duration

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

Applications Open

Timeline for MucInn Funding

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Mucosal Immunity Innovation ( MucInn) Teaming

Mucosal Immunity Innovation ( MucInn) Teaming

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

Last updated:
Location
Houston, TX, United States
Organization Type
  • Biotech
Core Development Category
  • Adjuvant & immune modulation
Technology Category
  • Mucosal adjuvants
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Activation of innate immunity via cGAS-STING pathway to treat and prevent respiratory viral infections. The platform technology has been developed as a mucosal adjuvant for various vaccine antigen types. In seven different animal models, AuraVax has shown safety and efficacy.

Influenza Vaccine Delivery in Nonclinical Models

In vivo research has shown that our mucosal adjuvant, NanoSTING-002, can safely boost the efficacy of subunit, WIV, and LAV antigens to provide protection to vaccinated subjects and block transmission of viral shedding to non-vaccinated subjects. Further, our research has shown that H1N1 LAV intranasal vaccines boosted with NansSTING-002 can provide cross protection to H5N1 challenge.

What We’re Seeking in Teaming Partners

The formulation, manufacturing, product characterization and preclinical research for NanoSTING-002 is completed. AuraVax believes the adjuvant is ready for preclinical vaccine development. Currently, the company is pursuing GLP toxicity and safety studies to submit an IND and begin human testing (NansSTING-001 as a host directed therapeutic).

Battelle Biomedical Research Center

Last updated:
Location
West Jefferson, OH, United States
Organization Type
  • Service Provider - CRO
Core Development Category
  • Preclinical models, immune evaluation
Technology Category
  • Other
Pre-clinical models and clinical trial bioanalysis experience
Current Stage of Development
  • Commercial

Primary Focus of Work

Battelle has established murine and ferret influenza infection models and conducted numerous vaccine efficacy studies. We have also established an influenza non-animal microphysiological system (MPS) using human lung cells. We maintain an influenza virus repository and can source novel strains as needed. We have validated HAI and microneutralization assays, along with a qualified NAI-ELLA, to support clinical trials. Our expertise includes creating, propagating, and characterizing candidate vaccine and wild-type influenza viruses, as well as using reverse genetics to generate recombinant viruses for cross-neutralization studies. Battelle’s rigorous quality management program supports IND filings.

Influenza Vaccine Delivery in Nonclinical Models

Battelle has tested multiple vaccine routes in our nonclinical models including intramuscular, intraperitoneal, subcutaneous, intranasal, inhalation, and intradermal.

What We’re Seeking in Teaming Partners

We are looking for partners in need of nonclinical studies (proof of concept, dose-down, efficacy, naive pharmacokinetic, infected pharmacokinetic, etc.) or bioanalysis studies in support of their clinical trials.

BIOQUAL, Inc.

Last updated:
Location
Rockville, MD, United States
Organization Type
  • Service Provider - CRO
Core Development Category
  • Preclinical models, immune evaluation
Technology Category
  • Delivery systems
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Preclinical Testing

Influenza Vaccine Delivery in Nonclinical Models

BIOQUAL can evaluate influenza vaccine candidates across relevant nonclinical models, including mice, ferrets, and nonhuman primates. Our capabilities support vaccine administration through various routes, including intramuscular, intranasal, subcutaneous, and other route-specific approaches, depending on the vaccine platform and study objectives.

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

Vaccine providers with the technology to design and formulate a vaccine.

Boost Biopharma, Inc.

Last updated:
Contact
Location
Boston, MA, United States
Organization Type
  • Biotech
Core Development Category
  • Antigen/Vaccine development
Technology Category
  • Antigen-adjuvant co-delivery
Current Stage of Development
  • Clinical stages

Primary Focus of Work

Boost's focus: novel protein subunit antigen platforms

Influenza Vaccine Delivery in Nonclinical Models

Boost's influenza antigens have been evaluated in NHPs, and the Rapid Vaccine Antigen (RVA) platform is clinically demonstrated.

What We’re Seeking in Teaming Partners

Boost is seeking partners with adjuvant and other technologies that could improve intranasal administration effectiveness of our protein subunit antigens. Boost's influenza antigens (non-adjuvanted) have already been demonstrated as safe and effective in NHPs, and we are seeking partners to further improve our vaccine performance.

Codagenix Inc

Last updated:
Contact
Location
Farmingdale, NY, United States
Organization Type
  • Biotech
Core Development Category
  • Antigen/Vaccine development
Technology Category
  • Other
Influenza live virus vaccines
Current Stage of Development
  • Clinical stages

Primary Focus of Work

2nd generation pandemic and seasonal live virus influenza vaccines

Influenza Vaccine Delivery in Nonclinical Models

Intranasal delivery demonstrated HAI and nAb responses in small and NHP animal models

What We’re Seeking in Teaming Partners

Deep and consistent intranasal upper respiratory tract delivery of live attenuated influenza vaccines

Duke University Regional Biocontainment Laboratory

Last updated:
Location
Durham, NC, United States
Organization Type
  • Academic/Research Organization
Core Development Category
  • Preclinical models, immune evaluation
Technology Category
  • Other
Our team performed many of the mouse and ferret preclinical vaccine immunogenicity and efficacy studies for the Duke Collaborative Influenza Vaccine Innovation Centers (CIVICs). We have the ability to use highly pathogenic avian influenza (HPAI) isolates in mice and ferrets. We also have the ability to perform direct contact transmission studies in ferrets, these are useful to determine if vaccines are able to prevent virus shedding that is able to transmit the virus to unvaccinated animals.
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Our research team is experienced with mouse and ferret models of influenza infection. Our team performed many of the mouse and ferret preclinical vaccine immunogenicity and efficacy studies for the Duke Collaborative Influenza Vaccine Innovation Centers (CIVICs). We have the ability to use highly pathogenic avian influenza (HPAI) isolates in mice and ferrets. We also have the ability to perform direct contact transmission studies in ferrets, these are useful to determine if vaccines are able to prevent virus shedding that is able to transmit the virus to unvaccinated animals.

Influenza Vaccine Delivery in Nonclinical Models

Our team performed many of the mouse and ferret preclinical vaccine immunogenicity and efficacy studies for the Duke Collaborative Influenza Vaccine Innovation Centers (CIVICs).

What We’re Seeking in Teaming Partners

Our team performed many of the mouse and ferret preclinical vaccine immunogenicity and efficacy studies for the Duke Collaborative Influenza Vaccine Innovation Centers (CIVICs). We have the ability to use highly pathogenic avian influenza (HPAI) isolates in mice and ferrets. We also have the ability to perform direct contact transmission studies in ferrets, these are useful to determine if vaccines are able to prevent virus shedding that is able to transmit the virus to unvaccinated animals. We are interested in partnering with MucInn teams to provide mouse and/or ferret vaccine immunogenicity and efficacy studies.

Dyadic International, Inc.

Last updated:
Location
Jupiter, FL, United States
Organization Type
  • Biotech
Core Development Category
  • Antigen/Vaccine development
Technology Category
  • Other
Protein antigens, including ferritin nanoparticles, trimers and fusion proteins
Current Stage of Development
  • Clinical stages

Primary Focus of Work

Rapid strain development, production and purification of protein antigens, enzymes, mAbs and other therapeutics

Influenza Vaccine Delivery in Nonclinical Models

Complex influenza antigens can be expressed that combined with the right adjuvant can generate protection against influenza viruses including avian influenza H5, H7 & H9 as well as H1, H3, NA, etc...

What We’re Seeking in Teaming Partners

We are looking for partners that need access to a robust, high yielding low-cost protein antigens that don't require viral clearance

InflammaSense

Last updated:
Location
La Jolla, CA, United States
Organization Type
  • Biotech
Core Development Category
  • Antigen/Vaccine development
Technology Category
  • Other
InflammaSense Classifies likelihood of Seroconversion and Reactogenecity
Current Stage of Development
  • Clinical stages

Primary Focus of Work

InflammaSense reads endogenous inflammatory states that indicate a future response to vaccination.

Influenza Vaccine Delivery in Nonclinical Models

InflammaSense is building a cadre of organ on chip models that emulate the host response to influenza vaccination and influenza infection.

What We’re Seeking in Teaming Partners

We hope to partner with Vaccine development groups interested in clinical trial platforms with organoid and assembloid system with the aim to provide high throughout drug and vaccination testing at scale.

Jurata Inc.

Last updated:
Contact
Location
Chapel Hill, NC, United States
Organization Type
  • Biotech
Core Development Category
  • Formulation technologies
Technology Category
  • Antigen-adjuvant co-delivery
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

A formulation technology platform that thermostabilizes a wide range of biologics for ambient storage, eliminating the need for cold-chain infrastructure. The platform also enables mucosal administration (such as oral, sublingual, or intranasal) via liquid or self-administered solid film presentations. Our technology process can be readily integrated into manufacturing fill/ finish with no change in the upstream drug substance process or need for administration devices or lyophilization to stabilize. Thermostabilization and mucosal administration has been demonstrated in multiple envelope viruses

Influenza Vaccine Delivery in Nonclinical Models

This mechanism enables viral antigens to remain protected during mucosal transit while being released at the appropriate immune inductive sites, supporting effective mucosal immune engagement. Key Features 1) Reversible polymer–antigen association without permanent encapsulation 2) pH-responsive protection during gastric transit 3) Increased antigen residence time at nasal, sublingual, and buccal surfaces 4) Preserved antigen integrity for uptake in GALT, NALT, SL/BU Mucosa

What We’re Seeking in Teaming Partners

Influenza vaccine candidates ranging from cell culture, to live attenuated to inactivated are all applicable to the Jurata mucosal administration and thermostabilization technology

SeromYx Systems

Last updated:
Location
Woburn, MA, United States
Organization Type
  • Service Provider - CRO
Core Development Category
  • Preclinical models, immune evaluation
Technology Category
  • Other
systems serology
Current Stage of Development
  • Clinical stages

Primary Focus of Work

Immune profiling linking antibody Fc biophysical and functional features to clinical outcomes SeromYx combines a broad repertoire of high throughput antibody effector function assays using serum and mucosal samples and machine learning to enable rapid, scalable, high-throughput, and high-resolution profiling of immune signatures of disease progression, protection, and resolution. Our platform delivers actionable biological insights at clinical and population scale and has been applied across infectious disease, inflammation, cancer, and neurodegeneration, supporting the full discovery and drug development continuum.

Influenza Vaccine Delivery in Nonclinical Models

Fc profiling in nonclinical models can identify influenza correlates of protection and discriminate between vaccine antigen compositions and adjuvant formulations, guiding decisions leading to clinical development

What We’re Seeking in Teaming Partners

We seek partners who have influenza expertise, interest in antibody function as a marker of protection, access to well-characterized clinical and/or preclinical mucosal sample sets, and capabilities in vaccine and/or antibody therapeutic development that would enable studies that track antibody profile changes with treatment.

TollereBio

Last updated:
Contact
Location
Silver Spring, MD, United States
Organization Type
  • Biotech
Core Development Category
  • Adjuvant & immune modulation
Technology Category
  • Mucosal adjuvants
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Vaccine adjuvants

Influenza Vaccine Delivery in Nonclinical Models

Published data available for the use of BECC adjuvants in influenza pre-clinical models

What We’re Seeking in Teaming Partners

TollereBio’s BECC adjuvant technology platform offers best in class, rationally designed TLR4 agonist adjuvants backed by pre-clinical data demonstrating the ability to elicit balanced Th1/Th2 immune responses, promote cross-protective immunity, enhance vaccine durability, and enable dose sparing. Our lead adjuvants BECC470s and BECC438s are fully synthetic, with structure specific purity and clear regulatory pathways for clinical development.

Transmucosis, University of Maryland

Last updated:
Location
College Park, MD, United States
Organization Type
  • Biotech
Core Development Category
  • Antigen/Vaccine development
Technology Category
  • Delivery systems
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

FcRn-mediated nasal delivery of influenza vaccine antigens

Influenza Vaccine Delivery in Nonclinical Models

FcRn is expressed in nasal and airway epithelial cells and facilitates the transfer of IgG across mucosal epithelial layers. Transmucosis is exploring the use of FcRn to deliver engineered influenza vaccine antigens via the nasal route. Our preclinical studies demonstrate that FcRn can effectively deliver viral vaccine antigens across the respiratory epithelial barrier, thereby inducing protective mucosal and systemic immunity against
the infection and transmission of respiratory viral infections.

What We’re Seeking in Teaming Partners

We are seeking a safe and effective mucosal adjuvant. We are also interested in a partner for manufacturing our vaccine antigen.

University of California, San Diego

Last updated:
Location
La Jolla, CA, United States
Organization Type
  • Academic/Research Organization
Core Development Category
  • Adjuvant & immune modulation
Technology Category
  • Mucosal adjuvants
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Development of vaccine adjuvants that are versatile for a broad range of respiratory pathogens

Influenza Vaccine Delivery in Nonclinical Models

The small-molecule immuno-enhancing agents will be formulated into nanoparticles containing antigens. Nanoparticles will enable transmucosal, slow delivery of antigens and adjuvants via the intranasal route.

What We’re Seeking in Teaming Partners

We seek the sources for (1) the antigens (the influenza virus proteins or components) and (2) pre-clinical evaluation service using ferrets.

VIOLET Pharmaceuticals

Last updated:
Location
Barcelona, Spain
Organization Type
  • Biotech
Core Development Category
  • Adjuvant & immune modulation
Technology Category
  • Mucosal adjuvants
Current Stage of Development
  • Pre-clinical

Primary Focus of Work

Our primary focus is to develop an mRNA-LNP technology to enhance the Antigen Presentation Machinery in host cells and thereby strengthen immune recognition and activation. By increasing the expression of key components involved in antigen processing and presentation, including the MHC class I pathway, our approach aims to improve the visibility of infected cells to the immune system and promote stronger activation of antigen-specific cytotoxic T-cell responses. In the context of mucosal viral infections, we are exploring the potential of our mRNA-LNPs as a mucosal immunomodulatory adjuvant that could enhance antigen presentation, support more effective antiviral immunity, and improve the clearance of infected cells when administered alongside, or incorporated into, antiviral or vaccine strategies. This work focuses on leveraging the host immune system rather than directly targeting the virus, with the goal of developing a broadly applicable platform for strengthening immune responses against respiratory and other mucosal viral infections.

Influenza Vaccine Delivery in Nonclinical Models

Our mRNA-LNP technology can strengthen antigen presentation and antiviral T-cell immunity. The mRNA payload encodes a transcriptional activator of the Antigen Presentation Machinery, including MHC class I pathway genes such as TAP1/2 and B2M, thereby enhancing the processing and surface display of viral antigens on infected cells. In established influenza infection models in mice, including lethal or sublethal challenge with strains such as PR8 (H1N1), our mRNA-LNP could be administered systemically or via routes compatible with respiratory immunity to increase the visibility of infected cells to CD8+ T cells and promote more efficient immune clearance. Because our platform has already demonstrated strong in vivo activity in enhancing antigen presentation and synergizing with immune-based therapies in multiple preclinical models, including lung metastasis settings, it provides a mechanistically grounded and translationally relevant approach to test our mRNA-LNPs as an immunomodulatory component that can improve the protective efficacy of influenza vaccines in nonclinical studies.

What We’re Seeking in Teaming Partners

In potential teaming partners, we are especially interested in groups that already have anti-viral candidates or platforms, so that we can jointly evaluate whether adding our mRNA-LNP technology improves the efficacy of their solutions in relevant influenza models. Beyond this, we seek complementary capabilities in mucosal vaccine development, influenza virology, and translational immunology to strengthen our proposal. Specifically, we value access to established nonclinical influenza infection models, including mouse and ferret systems, along with expertise in designing and executing challenge studies that measure survival, viral load, lung pathology, and antigen-specific T-cell and antibody responses. We also look for partners with experience in formulating and testing intranasal or other mucosal delivery platforms for mRNA-LNP vaccines, as well as analytical capabilities to assess biodistribution, mucosal immunity, and safety in the respiratory tract. On the regulatory and manufacturing side, we seek collaborators who can advise on or support GMP-compatible production of mRNA-LNP constructs suitable for mucosal administration and who understand the regulatory expectations for combination vaccine-adjuvant strategies targeting influenza. Finally, we are interested in partners with strong immunomonitoring and bioinformatics resources to dissect how enhanced antigen presentation shapes the quality, magnitude, and durability of anti-influenza immune responses, thereby de-risking translation and supporting a robust path toward clinical evaluation.

Wyss Institute at Harvard University

Last updated:
Location
Boston, MA, United States
Organization Type
  • Academic/Research Organization
Core Development Category
  • Drug delivery systems
Technology Category
  • Controlled-release technologies
Current Stage of Development
  • Early development

Primary Focus of Work

We have developed two technologies that allow for locally delivering vaccines to mucosal surfaces: 1) injectable biomaterial-based slow-release technologies that provide localized, controlled release of vaccine antigens and adjuvants, and 2) engineered proteins that can bind to mucins and anchor the biomaterials to mucosal surfaces, allowing for slow release vaccines directly to the mucosa. We are looking to partner with groups that have expertise in antigen/adjuvant development.

Influenza Vaccine Delivery in Nonclinical Models

The delivered slow-release vaccines are anchored to mucosal surfaces when delivered either orally or by inhalation, allowing for slow release of vaccines directly to the mucosa.

What We’re Seeking in Teaming Partners

We are looking to partner with groups that have expertise in antigen/adjuvant development

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.

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

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:

  • 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.

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.

No. mRNA-based and nucleic acid-based vaccine approaches are not within the scope of this funding opportunity. However, short nucleic acid oligos as adjuvants are in scope. Viral vector-based vaccines are not considered nucleic acid-based vaccines for this program.

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.

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:

  • 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.

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
  • 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

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.

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.

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.

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:

  • 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

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. 

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.

Awardees retain full ownership of any pre-existing background IP they bring into the project, as well as any new foreground IP generated during the performance of the award. However, because this program is federally funded, the contract contains standard U.S. government intellectual property contingencies and provisions. Each applicant should indicate, if they have the right to use, any intellectual property works that the submission comprises, that the works are wholly original with the entrant (or is an improved version of an existing work that the entrant has sufficient rights to use and improve), and that the submission does not infringe on any intellectual property rights of any third party of which the applicant is aware.