Partnerships To Develop Vaccines Against Select Enteric Pathogens

NIAID seeks applications for projects focused on advancing development of vaccine candidates against Enterotoxigenic Escherichia coli (ETEC), Salmonella enterica Serotype Paratyphi A, and two Shigella species—Shigella flexneri and Shigella sonnei—through the funding opportunity announcement (FOA) Partnerships for Development of Vaccines Against Select Enteric Pathogens (R01, Clinical Trial Not Allowed).

Research Objectives and Scope 

NIAID established the Partnerships program in 2002 to support discovery, preclinical research, product development, and eventual commercialization of candidate products that address specific pathogens and agents. This FOA supports milestone-driven preclinical research that will advance candidate vaccine development and production for select enteric pathogens or multivalent forms.  

Development of candidate vaccines should begin with previously identified, well-characterized immunogens for lead optimization and down-selection. NIAID expects projects to include proof-of-concept studies in animals or three-dimensional human-derived tissue models, preclinical evaluation, and, if warranted, process development and scale-up production under current good manufacturing practice (cGMP) to provide enough quantities for preclinical FDA-required animal and model studies and early preclinical evaluations. For advanced vaccine candidates, we encourage standard investigational new drug (IND)-enabling activities.  

Areas of Research Interest  

For all vaccine projects, applicants should consider the ultimate potential of a candidate vaccine to quickly induce safe and protective responses in diverse domestic and international populations. Vaccine projects may include one or more of the following product development activities: 

• Innovative modifications to extend pathogen scope and efficacy, e.g., combination vaccines 
• Optimization of delivery platforms, antigen, and adjuvant combinations/formulations 
• Comparison of vaccine candidate(s) to down-select candidates for further development  
• Lead vaccine candidate optimization 
• Evaluation of efficacy in challenge models where appropriate animal models are available 
• Optimization of dose and route of delivery in preclinical evaluations  
• Optimization of production methodology including process development 
• Scale up and production of candidate vaccines including cGMP production 
• Process development to produce vaccine components, including Quality Assurance/Quality Control, methods for product recovery, characterization, purification, identity, and stability  
• Manufacturing under good laboratory practice or cGMP to produce quantities sufficient for preclinical and early clinical evaluations  
• Performing preclinical testing for safety, toxicity, and efficacy in animal models and other benchmarks required for successful submission and review of an IND application by the FDA  

Industrial Participation 

Academic institutions that submit projects to this FOA must include substantive investment by at least one industry participant, defined as a significant commitment of one or more resources to the project, such as:

• Project and product development guidance/support (“consultation”)
• Personnel
• In-kind contributions of materials or reagents (e.g., innovative biotechnology platforms)
• Animal or other laboratory models for evaluation
• Subcontracts
• Data management resources
• Regulatory support
• Renovations of facilities or provision of equipment to address biohazard concerns

For projects with consultation-only investment, the industrial partner must commit a specific level of effort (concomitant to stage of preclinical or product development activities) that is included in the requested budget. Applicants may include support for industrial partner activities in the project budget. 

Nonresponsive Research Areas  

Applicants should keep in mind that research projects in the following areas will cause NIAID to deem their application nonresponsive and return it without review: 

• Projects focusing on discovery-based studies, such as identification of new antigens 
• Projects lacking appropriate proof-of-concept data supporting the targeted immunogens or candidate vaccine  
• Projects from academic institutes that lack substantive investment by at least one industry participant  
• Applications that focus on vaccine candidates for pathogens other than ETEC, Salmonella enterica serotype Paratyphi A, S. flexneri, or S. sonnei  
• Applications that propose clinical trials; however, you may include clinical development strategies within the overall project  

Deadline and Contact Information 

Applications are due on September 14, 2022, by 5 p.m. local time of the applicant organization. 

The application budget is capped at $750,000 in annual direct costs and the scope of the proposed project should determine the project period, although it cannot exceed five years.  

Direct any inquiries to Dr. Melody Mills, NIAID’s scientific/research contact, at 240-507-9576 or millsm@niaid.nih.gov. For peer review related questions, contact Dr. Annie Walker-Abbey, at 240-627-3390 or aabbey@niaid.nih.gov.