Key Dates

Related Announcements

• NOT-AI-25-001 - Notice of Early Expiration of "Notice of Special Interest (NOSI): Leveraging Microbial Exposure for Improving Mouse Models of Human Immunity", NOT-AI-21-072.
• May 07, 2020 – NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.
• May 05, 2020 – NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to invite applications proposing early-phase translational research to generate new malaria vaccine candidates or monoclonal antibody (mAb)-based interventions suitable for further downstream development and clinical evaluation, particularly for Plasmodium falciparum and P. vivax.

Background

Recently, the first-generation malaria vaccine RTS,S/AS01E, and a similar vaccine, R21/Matrix M, were recommended by the World Health Organization (WHO) for broad introduction in African countries for children more than 5 months old. Additionally, emerging clinical data show that passive immunization with malaria specific mAbs could provide protection in African adults and children. To address future effective global malaria control and elimination, WHO issued revised Preferred Product Characteristics (PPC) for future malaria vaccine development calling for new strategic priorities for next generation malaria vaccines, and a similar document outlining PPC and clinical development considerations for mAbs for malaria prevention.

Currently, however, due to significant scientific and technical challenges facing the malaria research and development community, there are very few preclinical and clinical candidates in the global development pipeline that possess promising features that meet the PPC-defined criteria. Continued innovation and transformative tools will be needed to address the challenges and achieve substantive breakthroughs. Recent advances in vaccine and mAb technologies present new opportunities to enable and accelerate research and development of highly efficacious and effective next generation vaccines, mAb, or other or Ab-based interventions (e.g., viral vectored or multi-specific Ab constructs) to combat malaria.

Research Objectives

The objective of this NOSI is to invite the research community to submit applications focused on early discovery of new and improved malaria vaccine candidates or mAbs or Ab-based concepts, especially for Plasmodium falciparum and P. vivax.  Investigators are encouraged to submit applications focusing on “combination” vaccine concepts to improve efficacy, targeting one or more parasite antigens or antigens of the different life cycle stages (i.e., pre-erythrocytic stage, blood stage, and/or sexual stage) of the parasites. Applications addressing broadly protective vaccines against multiple strains or species of the parasites and those providing long-last efficacy are strongly encouraged. Research identifying new or improved mAbs to support immunology research, vaccine immunogen design, or further preclinical development of Ab-based interventions for prophylactic application is also encouraged. Projects focusing on improved administration, manufacturability or deployment features of the relevant product concepts are highly encouraged. The goal is to broaden the global pipeline of product candidates suitable for downstream preclinical and clinical development for malaria prevention. 

The NOSI encourages research using appropriate assay systems or animal models to identify, characterize, credential and validate new protective antigens, mAbs or Ab-based constructs, or vaccine candidates. For the purposes of this NOSI, protective antigens, mAb constructs, or vaccine candidates should demonstrate appropriate functional characteristics, such as prevention of infection, disease amelioration, interruption of transmission, prevention of relapse, or other functional features, when applicable.

Examples of research topics include, but are not limited to: 

For vaccines:

• Identification, characterization, credentialing and/or validating novel protective malaria antigens/peptides/epitopes;
• Molecular immunogen design and testing using cutting edge innovations (e.g., artificial intelligence, machine learning, cryo-electron microscopy, structural immunobiology);
• Discovery of new vaccine candidates based on novel technology platforms, adjuvants, or vaccination strategies;
• Construction of novel whole organism-based malaria vaccines or improvements to existing whole organism-based malaria vaccines;
• Discovery of novel vaccine candidates or formulations that exhibit improved performance, manufacturability, or deliverability over existing vaccines;
• Discovery of new vaccine candidates or improvement of existing vaccine candidates to have more favorable storage conditions, or administration and deployment features;
• Screening, testing, credentialing and/or validating new vaccine candidates or formulations with novel assays or animal models.

For mAbs or novel Ab-based interventions:

• Identification and characterization of new functional mAbs, including broadly protective mAbs;
• Antibody engineering to improve functionality or stability, such as affinity/avidity, pharmacokinetic durability, or manufacturability;
• Novel platforms or strategies to express or deliver Abs or Ab-based products, including construction and testing of Ab-based concepts, such as viral-vectored, mRNA expressed, or bi- or multi-specific Ab constructs for improved product features to enhance prevention of malaria infection or transmission, or ameliorate malaria disease.

Application and Submission Information

This notice applies to application receipt dates on or after February 5, 2025 and subsequent receipt dates through November 16, 2027.

Submit applications for this initiative using one of the following Notices of Funding Opportunities (NOFOs)or any reissues of these announcements 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 funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AI-24-072” (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.

Inquiries

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: [email protected]

Financial/Grants Management Contact(s)

Samuel Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-4799
Email: [email protected]