Limited Submission Internal Deadline: A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy Against Malaria (U01-Clinical Trial Not Allowed)

 

 

 

Limited Submissions: Internal Call for Proposals 

A Multidisciplinary Approach to Study Vaccine-elicited Immunity and Efficacy against Malaria (U01 – Clinical Trial Not Allowed) 

UNC Internal deadline: 11:59PM, Tuesday, December 1, 2020 

                                                                                                                                         

 

*Please distribute to relevant faculty* 

Key Dates

UNC Internal deadline: 11:59PM, Tuesday, December 1, 2020 

NIH LOI Deadline: January 8, 2021

NIH Full Proposal Deadline: February 8, 2021 

Important Information

• Number of Applications per Institution: 1 

Award Information 

Funding Instrument: Cooperative Agreement

Award Budget: Application budgets are limited to $750,000 in direct costs per year and need to reflect the actual needs of the proposed project. 

Award Project Period: The scope of the proposed project should determine the project period. The maximum project period is 5 years. 

 

To Apply

Submit the following (in ONE .pdf) to Limited_Submission@unc.edu by 11:59PM, Tuesday, December 1, 2020.

 

1. PI/ Team members NIH-formatted biosketch
2. Project Summary (four-page maximum)
3. List of potential collaborators (internal and external to UNC) 
4. Names (along with title, department, and email) of three internal (to UNC) experts who could speak knowledgeably about the candidate’s research and who could potentially serve on an internal review panel. 

1. • Please do not include the names of faculty named on the project, chairs, deans, directors, direct reports, or others who have a conflict of interest
   • Please notify all potential internal reviewers before submitting the pre-proposal
     packet to ORD

 

Program Description 

The purpose of this initiative is to support research to advance understanding of the underlying immune mechanisms that contribute to malaria vaccine-elicited protection or vaccine hypo-responsiveness in endemic regions by capitalizing on recent research advances in systems vaccinology and systems immunology as well as emerging opportunities in data science and informatics. Multidisciplinary science and collaboration among investigators from the malaria vaccine research field and other relevant scientific areas are highly encouraged. The goal is to identify host signatures and mechanistic factors that influence malaria vaccine performance in endemic regions to guide and improve future vaccine design and evaluation.

 

This FOA will only support research topics related to pre-erythrocytic vaccines for Plasmodium parasites that cause human disease, especially P. falciparum and P. vivax. The goal is to gain a more mechanistic understanding of why endemic populations tend to be less responsive to malaria vaccination, and the challenges of achieving high level and durable protection conferred by pre-erythrocytic malaria vaccines in endemic areas. The successful outcome of this program is expected to guide future vaccine design and clinical evaluation that will more predictably accelerate translation of new candidates from the laboratory to the field.

 

Applications proposing research that will capitalize on recent scientific advances in systems immunology and vaccinology, as well as emerging opportunities in data science, informatics, and computational modeling are strongly encouraged. Applicants are encouraged to propose research efforts in one or more of the three major topic areas described below:

1. Baseline immune status: To characterize baseline human immune status and how it impacts or predicts malaria vaccine responsiveness, including the level or durability of protection. Applicants may propose to use data or samples from distinct cohorts from Controlled Human Malaria Infection (CHMI) studies or from other studies conducted in endemic areas to generate datasets for comprehensive analysis. Data or samples from malaria-naïve cohorts are acceptable as long as the study is linked to addressing malaria vaccine issues in endemic areas. For examples of studies on baseline immune status, please view the complete NIH solicitation.
2. Vaccine-elicited immunity and correlates of vaccine outcomes: To investigate vaccine-elicited immune responses, including innate, adaptive, and other cellular or molecular pathways, that are associated with vaccine immunogenicity and efficacy. Applicants may propose to acquire or generate large scale datasets (e.g., immune profiling) or other relevant data from vaccine clinical studies/trials and conduct integrated data analysis for hypothesis generation research. All datasets should include malaria vaccine and immunological data and other datasets that are relevant to achieving the proposed objectives. Hypothesis generation research should build on acquisition, generation, and analysis of immune profiling datasets, coupled with clinical metadata and vaccine end point assessment data. Analysis can also be performed by integration with other HTP datasets of systems biology studies. Data or samples can be from clinical cohorts residing in endemic areas or non-endemic areas (as long as the goal of the study is linked to vaccine outcome in endemic areas). Research that leads to the identification of correlates of protection or unique biosignatures that associate with or predict malaria vaccination outcomes are encouraged. For examples of studies on vaccine-elicited immunity or correlates of vaccine outcomes, please view the complete NIH solicitation.
3. Mechanistic studies: To investigate factors that contribute to variation in baseline immune status or to vaccine-induced protective immunity and efficacy. Applicants may propose to prospectively test and substantiate the derived hypotheses of significance using additional data or samples from alternative cohorts, unique in vitro systems, such as primary human cells, organoids, or human immune mimics, or novel animal models. Applicants may propose mechanistic studies with strong and convincing scientific hypotheses derived from previous human immune profiling research projects. For examples of mechanistic research studies, please view the complete NIH solicitation.

Program Considerations

Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:

• Research areas related to malaria vaccines targeting to other life cycle stages of Plasmodium (e.g., asexual stage, sexual stage);
• Research applications that involve blood stage or transmission stage immunity in human without a clear purpose of addressing pre-erythrocytic vaccine issues;
• Applications addressing Plasmodium of animal species or immune profiling of animals for the purpose of animal Plasmodium parasite research without a focus on pre-erythrocytic stage human vaccines;
• Studies that do not include an assessment of human immune profiles in response to pre-erythrocytic vaccines or human Plasmodium infection;
• Studies to address malaria natural acquired immunity or malaria epidemiology that are not linked to pre-erythrocytic vaccine efficacy research;
• Studies on baseline immunity or early response profiles without matching to malaria vaccine outcomes;
• Studies solely using in vitro culture systems (transformed human cell lines or organoids, etc.) or animal models;
• Systems immunology or systems biology studies that do not address pre-erythrocytic malaria vaccine issues;
• Applications to conduct antigen or vaccine discovery research, preclinical process development, or production and testing of clinical trial materials;
• Clinical trials (all phases), CHMI studies, malaria vaccine immunization program (Note: collecting data or samples from such studies that are implemented under other auspices will be supported).

Internal Review Criteria 

 

The internal review follows the NIH program criteria. Please view the complete list of review considerations within the NIH solicitation. https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-064.html#_Section_V._Application

 

Significance: To what extent will the anticipated results from the research adequately advance the understanding of the underlying immune mechanisms that contribute to malaria vaccine-elicited protection or vaccine hypo-responsiveness in endemic regions leading to the development of improved outcomes for humans? 

Investigator(s): Does the proposed research team leverage multi-disciplinary expertise to address the stated objectives? Are the designated personnel sufficient to enable compliance with the data- and other resource-sharing policy? 

Innovation: Does the research plan represent the best use of current or emerging knowledge and technologies to investigate and understand the underlying mechanisms accounted for malaria vaccine outcomes? 

Approach: Are the milestones/timelines provided well-justified and appropriate for the scope of the research project? Within the Data Management and Analysis Research Focus, how well do the structure, functions and staffing plan for this research focus support the unique research questions addressed? Are there appropriate bioinformatics infrastructure(s) to support the proposed activities? Is there adequate support for the development and use of novel analytical tools? Is the plan for sharing, access and release and public dissemination of generated data and research resources adequate and reasonable?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Information 

Full solicitation: https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-064.html

Please contact the Limited Submissions Team with questions at Limited_Submission@unc.edu

 

 

 

Limited Submissions Team

Office of Research Development

University of North Carolina at Chapel Hill

308 Bynum Hall

Chapel Hill, NC 27599

(919) 962-7503