See the Glossary for more terms.
Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.
NB: Council approval does not guarantee that a concept will become an initiative.
For the published request for applications, see the June 4, 2014, Guide announcement, Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention (IPCP-MBP) (U19).
Request for Applications
Contact: David Burns
Description: Applications may include phylogenetic studies, social and sexual network analyses, mathematical modeling, and studies to examine the acceptability and feasibility of new prevention interventions in the populations and settings identified. Research projects that integrate multiple approaches to achieve these objectives will be strongly encouraged. Mathematical modeling may be proposed to augment phylogenetic and network studies, as well as to examine the potential impact of new interventions. Applications will address the following objectives:
Contact: Vanessa Elharrar
Objective: This initiative seeks to provide a means to determine adherence to HIV treatment or prevention regimens. This will in turn support clinical trials of antiretroviral (ARV)-based prevention and treatment interventions that might otherwise be compromised by nonadherence.
Description: This initiative will support the development of bioanalytical tools and novel approaches that allow clinicians and researchers to provide people with timely feedback on adherence to ARV-based HIV treatment and prevention strategies.
Program Announcement Reviewed in an Institute
Contact: Karl Salzwedel
Objective: This initiative addresses a gap in the strategic path towards developing a cure for HIV infection/AIDS. Specifically, this initiative will fund research with a translational focus to develop new strategies for monitoring and targeting cells that constitute the reservoir of HIV that persists in patients on optimized highly active antiretroviral therapy (HAART) regimens to enable eradication of virus from the body. Of particular interest will be proposals that outline improved methods for characterizing latently-infected cells and persistent reservoirs, and strategies for killing reservoir cells or permanently inactivating integrated provirus.
Description: This initiative will fund innovative research proposals in five key areas that are directly related to the goal of developing effective strategies for eradicating HIV from infected individuals. These research areas are:
Each of these five areas represents a current research gap in the field. Advances made in these areas will greatly accelerate progress towards developing an effective strategy for curing HIV infection.
For the published request for applications, see the July 16, 2014, Guide announcement, U.S.-China Program for Research Toward a Cure for HIV/AIDS (R01).
Broad Agency Announcement
Contact: George Keane
Objective: Halt the spread of HIV infection by defining highly effective prevention strategies, including a preventive vaccine.
Description: The objective of the Staged Vaccine Development (SVD) initiative is to rapidly award as needed contracts for the advanced development/manufacture of specific promising candidate vaccines that have shown safety and immunogenicity in preclinical studies and early clinical trials, for further evaluation in Phase I/II/III clinical trials. Manufacturing support will be through a three-staged approach. Briefly the three contract stages are: 1) product development planning, 2) manufacture, and 3) regulatory/stability activities. Specifically the contract activities supported through this BAA will allow for further development of the following preselected "lead" HIV vaccine platforms: 1) recombinant HIV proteins, 2) pox viral vectors, 3) DNA vaccines, 4) replication defective adenoviral vectors, and 5) replication competent viral vectors.
The SVD will provide support for:
This initiative will advance vaccine products by a focused milestone-driven, Go/No-Go product development path through all three stages. Each contractor will focus on a specific vaccine candidate. The award will culminate in released vaccine products for testing in clinical trials.
Contact: Alan Schultz
Objective: This initiative will support multidisciplinary integrated projects that focus on HIV/AIDS prophylactic vaccine discovery research, including nonhuman primate (NHP) studies. Projects will have advanced past the exploratory stage and address the design and development and/or evaluation of an efficacious HIV/AIDS prophylactic vaccine.
Description: The HIVRAD program funds five-year projects that address the design of an efficacious HIV/AIDS prophylactic vaccine. Applications include plans that have advanced past the exploratory stage and include preliminary data. Applications may address the following areas of interest:
This renewal is being modified to also allow for support of translational research of HIV prophylactic vaccine projects at the latter stages of a hypothesis-driven HIVRAD project. Manufacturing is not supported. Examples of later stage translational research can include:
Contact: Richard Hafner
Objective: Tuberculosis infection-resistant individuals (TIRI) are those who do not develop active or latent Mycobacterium tuberculosis (MTB) infection despite heavy exposure to the pathogen. The objective of this initiative is to characterize the genetic, epigenetic, and immunological correlates of protection against TB infection in these individuals in the context of HIV infection.
Description: This initiative will support studies leading to a better understanding of the host factors determining resistance to TB infection and the effect of HIV coinfection. Specifically, this initiative will support studies examining the immunologic correlates of resistance to TB infection among individuals meeting the criteria for being TIRI. Evaluations may include identifying underlying immunogenetic/epigenetic factors, as well as characteristics of the innate immune system and related regulatory genes and signaling pathways that play a role in protection from latent TB infection. Multidisciplinary collaboration using advanced methodologies will be encouraged, incorporating clinical studies coupled with mechanistic experiments using samples and data from well-defined cohorts.
Contact: Sarah Read
Objective: Improve outcomes of treated HIV disease:
Description: This limited competition will support an award narrowly focused on supporting the completion of the START trial initiated under the INSIGHT Network award made in 2006 and extended for two years in 2013. The START trial will determine if immediate initiation of ART in HIV-1 infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm3 is superior to deferral of ART until the CD4+ declines below 350 cells/mm3 in terms of morbidity and mortality. The participants are randomized to begin ART either immediately or defer until the CD4 cells are 350/mm3 or less. Study participants are followed long-term to be evaluated for AIDS and serious non-AIDS events and death. The award will continue to support data management, a central laboratory with sample storage capacity, four coordinating centers, and 237 clinical research sites in 40 countries around the world.
Set-aside funding is needed to meet the research objectives of the study. The funding will allow for completion of study participant followup, analysis of laboratory specimens, analysis of the data and preparation of manuscripts, and presentations at scientific meetings.
Note: NIAID topic for NIH SBIR contract solicitation.
Request for Proposals
Contact: Eileen Webster-Cissel
Objective: To develop an inexpensive, simple, inhaled delivery system for CFZ to be used with combinations of systemic antitubercular drugs to improve the treatment of multidrug-resistant and drug-susceptible tuberculosis.
Description: Phase I research activities will include developing an inhaled formulation of CFZ; developing the platform for delivery of this formulation; and initial testing to quantitatively assess drug efficacy, toxicity, and pharmacokinetics including in vitro studies.
Phase II research activities will include preclinical studies such as in vivo testing in a standardized, reproducible, and validated small animal model.
Objective: To develop an inexpensive, easy-to-use process that will remove cells from finger-stick blood samples (approximately 500µL) before use in point-of-care (POC) viral load assays.
Description: Phase I research activities will include developing a method for removing cells or processing to plasma; integrating the process into a single unit; and initial testing of the product with at least one POC viral load technology blood samples spiked with several HIV subtypes.
Phase II activities will include validation testing with at least one POC viral load test (precision, accuracy, sensitivity, or specificity) against standard viral load tests; production under good manufacturing practices; developing a quality control program to ensure lot-to-lot consistency; and scale-up and production for multisite evaluations.
Last Updated July 16, 2014
Last Reviewed June 25, 2014