June 15, 2023
National Institute of Allergy and Infectious Diseases (NIAID)
The Notice of Special Interest (NOSI) invites applications to conduct research to better understand the basic biology and immunology associated with Cryptosporidium spp. (e.g., Cryptosporidium parvum and Cryptosporidium hominis), Giardia duodenalis (i.e., Giardia lamblia), and Entamoeba histolytica, including infection-induced mucosal immunity at the site of infection, leading to identification or discovery of new immune-mediated or host-directed interventions as countermeasures.
Background
Cryptosporidium spp. (e.g., Cryptosporidium parvum and Cryptosporidium hominis), Giardia duodenalis (i.e., Giardia lamblia), and Entamoeba histolytica form a group of enteric, eukaryotic, unicellular pathogens that are responsible for a substantial enteric disease burden in low- and middle-income countries (LMIC) and for which there are limited, suboptimal treatment options. Although frequently asymptomatic or self-limiting in immunocompetent persons, these infections are often chronic and sometimes fatal in immune compromised patients (e.g., HIV+ patients). In addition, these parasites possess a highly infectious, environmentally resistant stage during their life cycle that poses possibly significant impacts to disease and public health. They are identified as NIAID Biodefense Category B priority pathogens due to their contagiousness and potential threat to the safety of public water supplies and health. To date, there are no vaccines or other immune-mediated interventions available for treatment or prevention from infection or diseases caused by this group of parasites. Recent scientific advances in in vitro culture systems, and small animal models for Cryptosporidium spp. as well as new insights into mucosal biology and immunology regulatory pathways [e.g., Enteric Nervous System (ENS), Innate Lymphoid cells (ILCs), and Tuft cells], and the availability of a novel molecular toolbox, have enabled new research capabilities to further explore basic biology and immunological principles, host factors, and vaccine research for these mucosal, eukaryotic pathogens.
Research Objectives
This NOSI is to encourage comprehensive research efforts to better understand host-pathogen interactions and pathogen-specific immunity at mucosal sites, including infection-induced mucosal immunity at the site of infection, host target identification, antigen or immunogen discovery, and design and testing of vaccines, monoclonal antibodies (mAbs), or host-directed therapies.
Investigators are encouraged to submit applications that capitalize on recent scientific advances in biology of mucosal systems, biology and immunology of mucosal infection, and microbiome research, as well as emerging technologies such as transfection and molecular genetics, in vitro culture and natural mouse models, imaging or organoid culture, novel vaccinology platforms, mAb or mAb-related approaches, and other host-directed therapy modalities. Applications with collaboration formed among different scientific disciplines or different pathogen/disease areas are especially encouraged. Applications should address public health issues associated with this group of human pathogens: Cryptosporidium spp. (e.g., Cryptosporidium parvum and Cryptosporidium hominis), Giardia duodenalis (i.e., Giardia lamblia), and Entamoeba histolytica.
Activities may include, but are not limited, to the following:
- Parasite biology and host-parasite interaction at mucosal sites;
- Impact of mucosal biology, immunology, nervous system, and microbiome on pathogen pathogenesis and clearance;
- Pathogen-specific immunity, including correlates of protection;
- Establishment of biological assays for functional evaluation;
- Development of models that mimic pathophysiology of human disease [e.g., organoids, animals (including non-human primates)];
- Host target discovery, immunogen design, mAb identification;
- Discovery of vaccines, mAb product candidates or mAb-related interventions, or host-directed therapies, especially those using novel platforms.
Application and Submission Information
This notice applies to application receipt dates on or after October 5, 2023 and subsequent receipt dates through July 16, 2026.
Submit applications for this initiative using one of the following notices of funding opportunities (NOFOs) or any reissues of these opportunities through the expiration date of this notice.
- PA-20-185 – NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
- PA-20-195 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-AI-23-045” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:
Scientific/Research Contact(s)
Annie Mo, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240 627-3320
Email: moa@niaid.nih.gov
CDR John Pesce, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240 627-3343
Email: john.pesce@nih.gov
Glen C. McGugan, Jr., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3314
Email: gmcgugan@niaid.nih.gov
Financial/Grants Management Contact(s)
Vandhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: khuranav@nih.gov
and Human Services (HHS)
