September 2020 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, 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

Fiscal Year (FY) 2022 Concepts

Advancing Vaccine Adjuvant Research for Tuberculosis (TB)

For the published broad agency announcement, check the April 28, 2021 solicitation Advancing Vaccine Adjuvant Research for Tuberculosis (TB).

Clinical Pharmacology Quality Assurance Program

For the published request for proposals, check the December 28, 2020 solicitation Clinical Pharmacology Quality Assurance Program

Innate Immune Memory Impacting HIV Acquisition and/or Control

For the published request for applications, see the July 7, 2021 Guide announcement, Innate Immune Memory Impacting HIV Acquisition and/or Control (R21 Clinical Trial Not Allowed)

Consortia for Innovative AIDS Vaccine and Cure Research

Request for Applications—proposed FY 2022 initiative

Contacts: Nancy Miller and Brigitte Sanders

Objective: This initiative addresses two major NIAID scientific objectives: 1) halting the spread of HIV infection via a preventive HIV vaccine and 2) curing or controlling established HIV infection.

This initiative will use a multidisciplinary approach to conduct innovative vaccine and therapeutic studies in nonhuman primate (NHP) models to:

  1. Characterize vaccine-induced responses shown to protect from mucosal-route infection by SIV/SHIV, identify the correlates or mechanisms of protection afforded by these responses, and use this information to enhance vaccine-generated protection from infection.
  2. Develop post-infection interventions with the goal of eliminating viral reservoirs (cure) or enhancing virus control (elite controllers).

There are currently several experimental vaccines that reduce the rate of virus acquisition or prevent establishment of SIV or SHIV infection in vaccinated NHPs. The NHP model allows the opportunity to fully characterize vaccine-induced immune responses in blood and tissues, and to correlate these responses with the ability to lower the risk of infection or prevent establishment of SIV or SHIV infection after mucosal route challenge. Identifying and characterizing immune correlates or mechanism(s) of protection associated with these interventions will inform the design and development of current and novel HIV vaccine candidates with improved efficacy. A correlate (or mechanism) of protection from NHP studies, if reproduced in humans, would improve prioritization of candidate vaccines for further testing in humans.

In addition, this initiative will address a gap in the strategic path towards developing a cure for HIV infection. NHP models allow the opportunity to address questions not feasible in human studies, where evaluating the viral reservoir is generally limited to measuring viral DNA and RNA in blood and lymphoid tissue samples. This initiative will 1) fund research to investigate approaches to reduce or eradicate SIV or SHIV viral reservoirs in tissues, 2) allow extensive and comparative evaluation of therapeutic interventions on the size of the viral reservoir, and 3) support studies designed to establish effective immune control of virus replication in the absence of antiviral drug treatment.

Description: The vaccine focus of this initiative aims to identify the correlates and understand the mechanism(s) of vaccine-generated protection. Accordingly, applications will be expected to propose an AIDS vaccine that has demonstrated immunogenicity and efficacy (reduction of risk or prevention of infection) in a nonhuman primate model.

The cure focus of this initiative aims to apply immunological approaches to reducing or eliminating viral reservoirs and/or establishing control of viral replication to undetectable levels.

This initiative is intended to support a collaborative group of researchers with expertise in immunology, virology, molecular biology, animal models, and other related areas. Applications must address both vaccine and cure foci. Each application must designate a lead investigator for vaccine and a lead investigator for cure research, as the immunological approaches may be quite different, but collaboration between investigators is expected. The initiative will emphasize the need for increased involvement of vaccine investigators in developing immunologic means of virus control or elimination. Novel vaccines or innovative approaches will be necessary to establish antiviral immune responses that can control virus replication to undetectable levels after discontinuing antiviral drugs.

The vaccine focus will use NHPs to evaluate vaccine responses and efficacy, and to identify correlates and mechanisms of vaccine efficacy.

The cure focus will use NHP to evaluate effects of innovative approaches on the reduction of viral reservoirs, as well as the characterization of immune effector functions that can result in control of virus replication in the absence of antiviral drug therapy.

Exclusions include using non-immunological approaches to achieve virus control, as these are supported by other NIAID DAIDS initiatives. Proposals to conduct human studies are not allowed. However, the use of samples from human studies supported elsewhere is encouraged, if needed for comparative purposes.

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