Mucosal Environment and HIV Prevention (MEHP II) (R01)
Grant Amount: The NIAID intends to commit $1,200,000 in FY 2015 to fund 1-2 awards.
The purpose of this FOA is to stimulate research to better understand and optimize the interaction of genital (female and male) and gastrointestinal (GI) tract mucosa with non-vaccine biomedical prevention (nBP) candidates and strategies with the long-term goal of enhancing the safety and efficacy of HIV prevention interventions. To achieve this goal, this FOA will support hypothesis–driven biomedical research projects, addressing the following 3 underserved emerging areas of Programmatic interest:
(1) The role of different mucosal site physiological states in altering nBP safety and efficacy. Examples include, but are not limited to: normal, inflamed, and/or wounded tissue (from sexual activity or sexual violence, etc.), (2) Pharmacokinetic (PK)/ pharmacodynamic (PD) relationships of nBP candidates in different mucosal compartments and novel models to measure these relationships, and (3) Studies into the basic and molecular cellular and biological mechanisms by which female and/or male hormones, age, immune factors, genital secretions and the microbiome (bacterial, viral, archeal, fungal) affect HIV susceptibility and efficacy of nBP.
The male and female genital and GI mucosal tissues are modulated by a wide variety of endogenous and exogenous factors. Different commensal flora, unique innate and adaptive immune response mechanisms, immune cell compositions, and hormones continuously alter the physiology of these tissues. Numerous studies have shown that active pharmaceutical ingredients (APIs), delivery vehicles and formulations/excipients can induce changes in the mucosa, such as loosening of epithelial tight and adherent junctions, alter innate and/or adaptive immune mediators (i.e. inflammation), and modulate immune cell content (i.e. homing and trafficking). Sexually transmitted infections (STI) associated with HIV acquisition can also modulate genital and GI tract mucosal susceptibility to HIV transmission/acquisition in the absence of gross evidence of toxicity or damage to the tissues. Although not all mucosal changes induced by prevention candidates or strategies have been linked directly to altered HIV acquisition/transmission risk, these changes represent modifications of the physical and active barriers to HIV infection that, under the right circumstances, could positively or negatively modulate susceptibility to HIV infection.
Investigators are encouraged to develop applications that are hypothesis-driven with the goal of understanding the effects of nBP APIs, delivery vehicles, formulations/excipients and/or contraceptives on the genital and GI mucosa and HIV target cells. Applications with hypothesis-generating or descriptive studies are discouraged. For the purposes of this FOA, hypothesis-generating/descriptive applications are defined as those which propose descriptive and/or conditional analysis/surveys of mucosal environmental factors and responses to identify impacts on the mucosal environment, which might alter HIV susceptibility and/or nBP efficacy. Hypothesis-generating studies often involve broad surveys of hormonal and microbiome changes using systems biology approaches, i.e. “omics” or cytokine arrays, resulting in descriptive data sets that are used to tentatively identify factors or conditions that are proposed to negatively or positively impact the mucosal environment, nBP safety and/or susceptibility to HIV Infection.
It is not the purpose of this FOA to develop new prevention candidates, strategies, or delivery systems but to use existing candidates, strategies, and delivery systems as tools to probe the HIV target mucosa to develop a knowledge base that will lead to the creation of novel "mucosal friendly" prevention strategies.
National Institute of Allergy and Infectious Diseases Division of AIDS
City Agencies Colleges/Universities Commercial Organizations Community Based Organizations County Agencies Educational Organizations/Institutions Federal Government Agencies International Agencies IRS 501 (c)(3) Organizations Nonprofit Organizations Religious Organizations Schools State Agencies Tribal Organizations
Number of Awards Given
Award Amount Notes
The NIAID intends to commit $1,200,000 in FY 2015 to fund 1-2 awards.
Clinical Research HIV/AIDS Prevention Pharmaceutical Research
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf), including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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