September 2017 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests 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 Opportunities & Announcements .

NB: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Consortia for HIV/AIDS Vaccine Development (CHAVD)

For the published request for applications, see the February 7, 2018 Guide announcement, Consortia for HIV/AIDS Vaccine Development (CHAVD) (UM1, Clinical Trial Not Allowed).

HIV Vaccine Research and Design (HIVRAD) Program

For the published program announcement with special receipt, referral, and/or review considerations, see the October 13, 2017 Guide announcement, HIV Vaccine Research and Design (HIVRAD) Program (P01 Clinical Trial Not Allowed)

Advancing mAbs To Clear Early HIV Infection or Achieve a Sustained Virologic Remission

Request for Applications—proposed FY 2019 initiative

Contact: Tia Morton

Objective: The objectives of this initiative are to facilitate the early clinical development of monoclonal antibodies (mAbs) that have preclinical data demonstrating the mAb(s) is/are safe and prevent the establishment of or reduce/eliminate an established HIV/SHIV/SIV reservoir; or achieve a drug free sustained virologic remission. At the end of the five-year grant, it is expected that sufficient clinical data will be available to determine whether further clinical development of the mAb(s) is/are warranted in larger efficacy trials.

Description: This request for applications seeks to support first-in-human/first-in-HIV through proof-of-concept studies in HIV-infected individuals with mAb(s) that meet the criteria defined above. It is expected that the first clinical study using current Good Manufacturing Practices manufactured mAb(s) will begin enrolling within nine months of award. Funding for follow-on studies within this grant require that the safety, pharmacokinetics, and efficacy data meet predefined Go criteria approved by DAIDS. Trials using broadly neutralizing antibodies are responsive provided they meet the criteria defined in the Objective(s) section. Pediatric studies can be considered once adequate safety data are available.

Advancing HIV Therapeutic Vaccine Science

Request for Applications—proposed FY 2019 initiative

Contact: Steve Smiley

Objective: This initiative will advance therapeutic vaccine science through understanding of the vaccination strategies and immune response mechanisms that effectively control HIV infections in humans. A better understanding of the immunologic responses that can be induced by vaccination and their impacts on virologic measures will support the longer-term goals of identifying therapeutic vaccine strategies that sustainably reduce HIV viral load and eradicate HIV infection. At the end of five years, we expect that several of the many variables related to therapeutic vaccines will be better understood. Ideally, the data generated through this initiative will support the advancement of one or more strategies to later stage clinical trials.

Description: These awards will fund small comparative trials in virologically suppressed humans infected with HIV. Applicants will propose a desired immune response and a vaccination strategy designed to elicit that response. Trials will include head-to-head comparisons of vaccines, adjuncts, doses, and/or schedules. Investigators will strive to identify correlates between immunologic and virologic responses and then work iteratively to improve those responses through additional head-to-head comparisons. For studies proposing use of investigational agents, applicants must be prepared to submit an investigational new drug application by the time of award. Projects will be encouraged to leverage DAIDS resources and/or external support. This reissue of RFA-AI-16-019 will not contain substantive changes.

Sustained Release Innovation for HIV

Request for Applications—proposed FY 2019 initiative

Contact: Jim Turpin

Objective: The overarching objective of Sustained Release Innovation (SRI) is to support the development of proof-of-concept/high-risk innovation sustained release (SR) products integrating engineering and preferred user characteristics into the product development/optimization pathway. The initiative addresses the increased interest of NIAID in sustained/extended release strategies to prevent HIV transmission/infection. The objective of SRI is to expand sustained/extended release research for HIV prevention through a high-risk/innovation program that goes beyond previous funding opportunity announcements by focusing on new products and drug delivery systems (DDS) with the potential for increased impact through extended windows of protection and integration of product development with user informed design of the proposed products.

Description: This initiative is designed to stimulate the development of novel non-vaccine biomedical prevention (nBP) sustained/extended release products for preventing HIV transmission and acquisition. Sustained/extended release is defined as a product that either releases drug continuously from a device or is administered once providing extended protection from HIV infection. Extended release addresses the duration of protection. The initiative will be structured to support developing new innovative approaches and will not support optimizing currently funded approaches (drugs, DDS, or durations). Applicants will be encouraged to develop longer durations of action that are commensurate with known drug pharmacokinetics (PK) and/or theoretical capacity of the DDS used. Minimal duration of action will be specified in the initiative for each DDS type.

The R61/R33 phased awards will require milestones in both phases. The initiative will require including an industry partner as a significant collaborator in the application. The three-year R61 will require proof-of-concept of the nBP product SR strategy through proposed duration of use pharmacokinetic studies in in vitro and in vivo (animal) models. Any proposed strategy will be required to provide protection for both the male and female genital and gastrointestinal tracts, and it is envisioned that milestones will address duration of release and the PK tail and lag periods of the proposed strategy. R33 milestones will be required, with a milestone for submission of a pre-investigational new drug package to the FDA by the end of year four.

Because use and uptake of nBP products will be dependent upon user willingness to use the SR strategy, applicants will be highly encouraged to integrate specific milestones and studies to link Preferred User Characteristics (PUC) to the rheological and biophysical properties of the proposed product/strategy DDS. It is envisioned that these studies will be accomplished using techniques such as ethnographic studies of potential user groups (adolescents, young adults, and at-risk groups, e.g., men who have sex with men, transgenders, blacks, Hispanics), mental modeling, perceptibility, user journey, and discrete choice experiments with prototype delivery systems. The overarching objective of SRI is to:

Support the development of proof-of-concept/high-risk innovation sustained/extended release products integrating drug and drug delivery system engineering and PUC into the product development/optimization pathway.

Next Generation Multipurpose Prevention Technologies

For the published request for applications, see the September 12, 2017 Guide announcement, Next Generation Multipurpose Prevention Technologies (NGM) (R61/R33-Clinical Trials Optional) .

Getting to Zero: Understanding HIV Viral Suppression and Transmission in the United States

For the published program announcement with special receipt, referral, and/or review considerations, see the November 16, 2017 Guide announcement, Getting To Zero: Understanding HIV Viral Suppression and Transmission in the United States (R01 Clinical Trial Not Allowed)

Content last reviewed on February 9, 2018