University of Southern California

Research

RFA-AI-19-015, Atopic Dermatitis Research Network -Clinical Research Centers (U01 Clinical Trial Optional)

Slots:                                                     One per institution; however, Applicants may submit to both the ADRN-LC (RFA-AI-19-014) and ADRN-CRC (RFA-AI-19-015) funding opportunities. However, different clinical projects must be proposed in each of the two applications. Call 240-669-5070 or email               

Internal Deadline:                           Contact the Office of Research if interested.

LOI:                                                        June 7, 2019       

External Deadline:                          July 8, 2019, by 5:00 PM local time of applicant organization.

Award Information:                        Type:  Cooperative Agreement

Estimated Number of Awards: NIAID intends to commit up to $2.0 million in FY 2020 to fund 3-4 awards.

Anticipated Amount: Application budgets are limited to $300,000 in direct costs and need to reflect the actual needs of the proposed project.

Submission Process:                     PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants

Materials to submit:

Link to Award:                                  https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-19-015.html

Who May Serve as PI:                    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Purpose:

AD is recognized as a research need by the NIAID Strategic Plan for Biodefense Research. In its 3 iterations, the ADRN has carefully examined various aspects of the cutaneous immune system in patients with atopic dermatitis and healthy individuals and has identified at least 3 instances where a specific AD patient group has diminished host defense compared to another: (a) patients with severe versus moderate or mild atopic dermatitis; (b) patients with atopic dermatitis and a history of eczema herpeticum versus patients with no history of this condition; and (c) individuals with genetic filaggrin-deficiency versus no deficiency in filaggrin. In addition to identifying these groups of atopic dermatitis patients who are at risk for complications from various infectious processes, the ADRN has generated pivotal knowledge on the structure and function of the skin including abnormalities of the skin barrier, the generation of anti-microbial peptides, the skin’s lipidomic profile and its susceptibility to Staphylococcus aureus (S. aureus) colonization.

The objectives of the ADRN-CRCs are to a) conduct the network-wide ADRN clinical research projects under the leadership of the ADRN-LC, b) conduct center-specific, clinical or laboratory, human-sample based research within the scope of ADRN and c) contribute to the overall ADRN strategic goals by participating in the ADRN Steering Committee and other network functions.

ADRN-CRC will propose only center-specific research projects.  These projects can be small, mechanistic clinical trials, small, human observational/mechanistic studies or laboratory studies utilizing new or existing human biologic samples.

Applications proposing the following topics will be deemed non-responsive and will not be reviewed.

    • Research on HIV/AIDS.
    • Phase III, IV or V clinical trials.
    • Clinical trials testing clinical efficacy of therapeutic interventions.
    • Clinical studies or clinical trials performed at a Foreign site. Note: Foreign Components may only provide services in support of Clinical Study or Clinical Trial activities (e.g. conduct of laboratory assays).  Foreign Components must not conduct Clinical Trials or Clinical Studies.

Structure of the ADRN Clinical Research Centers:

The ADRN-CRCs will conduct network-wide and center-specific research. To accomplish this the ADRN-CRC should provide:

  1. Clinical Research Functions:This will involve personnel and facilities capable of conducting network-wide and ADRN-CRC center-specific research, including trained clinical staff, capabilities of recruiting adult and pediatric atopic dermatitis populations, clinical research facilities, investigational pharmacy services, and laboratory facility capable of processing, storing and shipping human biosamples. For center-specific research, additional requirements include an active, IRB-approved protocol for recruitment and clinical characterization of AD patients, a data management facility with established data management, quality control plans, and capability to upload data into the NIAID designated repositories and biostatistical support.
  1. CRC Specific Research Projects:At least two, center-specific clinical research projects organized around a common theme or hypothesis.  These could include one or more protocols that test a hypothesis associated with a specific AD phenotype or endotype with immunologic, skin barrier, skin microbiome or other focus of pathophysiologic importance in AD. These projects may range from a small mechanistic clinical trial to an observational study and to in vitro or ex vivo testing of human biosamples. Studies using only transformed human cell lines will not count toward this requirement. Limited animal research may be included for experimentation that is not possible in humans or with human materials. The animal studies must be necessary and must be fully integrated into a plan that will translate animal findings in human disease.