Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP-MBP) (U19)
Grant Amount: NIAID intends to commit $9.1 million yearly for 1 to 3 awards.
The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from single institutions and consortia of institutions to participate in the Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP-MBP). The purpose of this FOA is to support integrated and iterative multi-project, multi-disciplinary preclinical development efforts and exploratory clinical studies with the goal of advancing, strengthening and maintaining an innovative pipeline of non-vaccine biomedical prevention (nBP) strategies, including microbicides, PrEP, and Multipurpose Prevention Technologies (MPT). The purpose of the multi-project and core environment of the IPCP-MBP is to stimulate and support a strong, diverse base in preclinical discovery and development of nBP candidates that includes development of single and combination nBP delivered to the male and female genital and gastrointestinal (GI) tracts to prevent HIV acquisition/transmission. The purpose will be accomplished by supporting the translation of candidates and strategies from preclinical to pre-Phase I clinical studies delivered by a variety of drug delivery systems (DDS), including gels, films, quick dissolving tablets, intravaginal rings (IVR), implants, oral, injection and MPT-based DDS strategies. A minimum of two research projects and an Administrative Core must be proposed. At least one component (research project or Scientific Core) must be from a private sector for-profit or not-for-profit company. The proposed research is not required to include a pre-Phase I clinical trial or provide comprehensive coverage for all activities that might be required to develop a specific candidate or strategy for advancement to clinical trials.
NOTE: While pre-Phase I clinical trials conducted within the continental United States (U.S.) are responsive, Pre-Phase I clinical trials proposed to be conducted at non-U.S. sites will not be supported under this FOA. This FOA will not support any clinical trials (Phase I, II or III) that do not meet the definition of a pre-Phase I clinical trial. Applicants are encouraged to seek other sources of support for traditional Phase I, II, or III clinical trials and the production of drug substance and products required to support them.
National Institute of Allergy and Infectious Diseases Division of Intramural Research
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
1 to 3 awards
Award Amount Notes
NIAID intends to commit $9.1 million yearly for 1 to 3 awards.
An applicant may request a project period of up to 4 years for an application that does not include a pre-Phase I clinical trial, and up to 5 years for an application that includes a pre-Phase I clinical trial.
Clinical Research Clinical Trials HIV/AIDS Prevention
Applicants can access 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), 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.
Disclaimer: NPIN provides this information as a public service only. The views and information provided about the materials, funding opportunities, and organizations do not necessarily state or reflect those of the U.S. Department of Health and Human Services, CDC, or NPIN.