May 2012 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
Mucosal Environment and HIV Prevention
For the published request for applications, see the March 7, 2013, Guide announcement.
Mechanisms of Cellular Immunity in the Female Reproductive Tract
For the published request for applications, see the March 7, 2013, Guide announcement.
Research in Latent Tuberculosis Infection (LTBI) in the Setting of HIV Coinfection
For the published program announcement identifying location of peer review, see the December 20, 2012, Guide announcement.
Immunology Quality Assessment
Request for Proposals
Contact: Robert Corno
Objective: To continue providing a critically needed resource that:
- Evaluates the abilities of laboratories in the U.S. and in developing countries to accurately and reliably perform study-specified immunological tests (mainly CD4 and CD8 enumeration) and peripheral blood mononuclear cell (PBMC) viable freezing.
- Advises and trains when deficiencies are identified.
- Evaluates immunology-based technologies for implementation in multisite DAIDS trials.
Description:
- Develop approaches to ensure quality and reliability of measuring novel immunologic tests such as immune activation (e.g., CD38).
- Prepare proficiency testing (PT) panels for more than 70 U.S. CD4 labs and assess performance. Specifically:
- Assemble a pool of well-characterized donors.
- Prepare and ship to labs PT panels from appropriate materials (e.g., whole blood, plasma).
- Analyze and grade PT results from labs.
- Guide laboratories in investigating root causes to prevent future failures and help correct deficiencies.
- Assess performance of more than 45 non-U.S. CD4 labs in 17 countries (PT panels will be provided by the United Kingdom National External Quality Assessment Service (UKNEQAS) or other providers).
- Assess performance of more than 65 U.S. and more than 30 non-U.S. PBMC freezing laboratories in 12 countries.
- Provide guidance and training to laboratories by various means to achieve proficiency in CD4/CD8/CD19 testing and PBMC viable freezing. Guidance and training will be done by email and phone communications, interactive Web conferences, presentations at investigator meetings and regional training events, and visits to struggling laboratories.
- Maintain a Web-based information repository that includes lab-specific documents, such as records of resolution of findings at a lab visit and performance in proficiency testing panels, and a resource library that includes guidance documents and standard operating procedures for various laboratory procedures (e.g., how to validate instrument). The contractor will provide each participating laboratory with access to its own documents and provide NIAID and Network lab managers with access to all documents.
- Generate lab-specific reports for each lab indicating the degree of performance for each round of proficiency testing; summary reports indicating, for DAIDS and the Networks, the proficiency status of all laboratories; and triannual and annual progress reports.
- Evaluate immunology-based, low-cost technologies for implementation in multisite DAIDS trials (e.g., point-of-case CD4 enumeration methodologies).
NIAID Specimen Repository
Request for Proposals
Contact: Kishan Patel
Objective: To continue providing critically needed comprehensive services related to operating the NIAID Specimen Repository (NSR), and continue to help:
- Secure, receive, catalog, process, aliquot, store, and disburse human biological specimens from subjects participating in DAIDS-sponsored cohort studies and clinical networks.
- Provide adequate cold storage facilities.
- Remain current on novel procedures for optimized storage of clinical specimens and be able to use state-of-the-art technology to ensure specimen integrity from receipt to storage in the freezers and from freezers to shipment containers for outgoing shipments.
- Provide (or use the current) computerized Specimen Inventory Database Management System (SIDMS) that supports the repository's functions.
- Develop, perform, and maintain Quality Assurance (QA)/Quality Control (QC) Program for the NSR facility, operations, stored biospecimens, shipping materials, and personnel in accordance with all applicable federal, state, and local regulatory requirements.
Description: This initiative will:
- Serve and support current and future epidemiological cohort study groups referred to as Study Groups. NSR will support the following ongoing NIAID Study Groups, noted in order of greatest to least numbers of stored specimens: the Women's Interagency HIV Study (WIHS), the Multicenter AIDS Cohort Study (MACS), the HIV Vaccine Trials Network (HVTN), and the HIV Prevention Trials Network (HPTN). NSR will also maintain specimens from other NIAID-sponsored studies that either have been completed—such as the AIDS Vaccine Evaluation Group (AVEG), the HIV Transmission Network (HIVNET), the Jump Start Project, the Heterosexual HIV Transmission Study (HATS), the Division of AIDS Treatment Research Initiative (DATRI)—or from Study Groups that currently send newly-generated specimens to another repository, such as the Adult and Pediatric AIDS Clinical Trials Group (AACTG).
- Support the short, moderate, and long-term specimen storage component of the domestic and international research agendas of the Study Groups. Retrieval and distribution of specimens is guided by the scientific priorities of the Executive or Advisory Committees of the various respective Study Groups. These specimens include peripheral blood mononuclear cells, serum, plasma, tissue specimens, and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, mucosal, autopsy and biopsy materials, and whole blood spots dried on filter paper.
- Support, through receipt or shipment of specimens, over 300 domestic and international laboratories that are either part of the Study Group (referred to as Sites) or laboratories collaborating with the Study Groups (referred to as external research groups).
Preclinical Development Services for AIDS Therapeutics
Request for Proposals
Contact: Craig Heggestad
Objective: To advance the development of products for the treatment of HIV and its coinfections.
Description: This initiative will provide contract services to facilitate the preclinical development of potential therapeutic agents. These services will include:
- Analytical chemistry evaluation of drug substances and dosage formulations.
- Drug formulation and dosage form manufacture.
- Pharmacology and toxicology studies in animals.
Services will be conducted in compliance with current FDA guidelines regarding Good Laboratory Practice and Good Manufacturing Practice when appropriate. This initiative is a modification of therapeutics development initiatives proposed in previous years. The current initiative will incorporate into one solicitation services that previously were proposed in separate initiatives.