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June 2014 DAIDS Council-Approved Concepts

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.

Table of Contents

Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP-MBP)

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).

Increased Knowledge and Innovative Strategies to Reduce HIV Incidence—iKnow Projects

Request for Applications

Contact: David Burns


  • To promote innovative research to improve our ability to identify populations that are both at high risk of HIV-1 infection and have a high proportion of people that are unaware of their HIV status.
  • To successfully link them to HIV testing, effective prevention interventions, and, if HIV-positive, care and treatment.

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:

  1. Devise optimal strategies to identify people unaware of their HIV infection in specific high-risk populations and settings.
  2. Increase uptake of HIV testing and linkage to prevention services, care, and treatment in these populations.
  3. Develop and examine the feasibility and acceptability of integrated biomedical and behavioral interventions that substantially reduce the likelihood of onward HIV transmission in these populations.

Adherence to ARV-Based Treatment and Prevention

Request for Applications

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.

Targeting Persistent HIV Reservoirs

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:

  1. Develop new methods to isolate, image, quantify, and characterize cells that constitute the persistent reservoir of HIV in infected individuals on HAART.
  2. Identify more specific, potent reactivators of latent HIV gene expression to permit selective targeting of reservoir cells.
  3. Identify molecular biomarkers/signatures associated with latently-infected cells to obviate the need to reactivate HIV gene expression for targeting.
  4. Develop approaches to efficiently kill latently-infected cells or tag cells for efficient immune clearance.
  5. Develop approaches to permanently inactivate integrated provirus in latently-infected cells.

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.

U.S.-China Program for Research Toward a Cure for HIV/AIDS

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).

Staged Vaccine Development

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:

  1. Tech transfer of all processes for manufacturing.
  2. Development of scale-up of manufacturing processes.
  3. cGMP manufacture.
  4. All investigational new drug-enabling safety studies.
  5. Quality assurance release of clinical trial material.
  6. All necessary regulatory filings such as CMC (chemistry, manufacture, control) or Biological Master file.
  7. Ancillary analytical in vitro and in vivo studies.
  8. Stability program/storage for the product(s).

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.

HIV Vaccine Research and Design (HIVRAD)

Program Announcement Reviewed in an Institute

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:

  • Elicit durable and broadly neutralizing antibodies against HIV and/or SIV.
  • Identify correlates of vaccine-induced immune protection to HIV/AIDS.
  • HIV structural studies as they relate to designing HIV immunogens.
  • Improved animal model systems (and challenge viruses) to address vaccine efficacy.
  • Increase the immunogenicity of HIV antigens (e.g., novel adjuvants).
  • Vaccine design to better address the heterogeneity of HIV.
  • Improved viral or bacterial vaccine vectors.
  • Mobilize immune cells to the portal of infection.

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:

  • Further vaccine optimization for increased expression, improved safety, etc.
  • Further process optimization.
  • Develop analytic approaches to evaluate potency.
  • Focus on novel processes, cell substrates to accelerate vaccine development, yield, purity, etc.
  • Develop and use innovative in vitro systems and humanized murine models to access HIV vaccine potency and safety.
  • The role of glycan structures on immunogenicity, antigenicity, and infectivity.
  • Innate immunity to alter the outcome of infection.

Mechanisms of Immune Protection From TB Among HIV-Infected Individuals

Request for Applications

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.

Limited Competition: Strategic Timing of Antiretroviral Treatment (START)

Request for Applications

Contact: Sarah Read

Objective: Improve outcomes of treated HIV disease:

  • Define long-term consequences of treated HIV infection and the mechanisms of morbidity associated with treated HIV disease.
  • Explore the role of HIV in the development of premature immune senescence in HIV-infected individuals on suppressive antiretroviral treatment (ART).

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.

Inhaled Delivery of Clofazimine (CFZ)—An Important Antituberculosis Drug

For the published request for proposals, see the August 15, 2014, Solicitation of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals.

Simple, Inexpensive Unit for Removing Cells From Small Amounts of Blood in Resource-Limited Settings

For the published request for proposals, see the August 15, 2014, Solicitation of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals.

Last Updated August 20, 2014

Last Reviewed June 25, 2014