May 2006 DMID Council-Approved Concepts

If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIAID Funding Opportunities.

Table of Contents

• Development of Animal Models and Assays for Plague Vaccines
• Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases
• Cooperative Research Partnerships for Biodefense

Development of Animal Models and Assays for Plague Vaccines

Cancelled

Request for Proposals

Contact: David Lisle
Phone: 301/451-2617
Internet: dlisle@niaid.nih.gov

Objective: To continue advanced product development for a recombinant plague vaccine based on the F1 and V antigens, to protect at risk populations and to support vaccine licensure.

Description: This initiative will develop, refine, qualify, and validate immunoassays and animal efficacy models to better support continued advanced development of a plague vaccine. Assays must be designed that are product-neutral, i.e., can be applied equally to any vaccine based on the F1 and V antigens, whether fused or produced separately, and whether formulated for parenteral or mucosal delivery.

Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases

For the published initiative, see the January 2, 2007, solicitation.

Request for Proposals

Contact: Debby Baca
Phone: 301/443-4490
Internet: dbaca@niaid.nih.gov

Objective: To provide comprehensive statistical support, data management, and analysis activities for DMID-sponsored clinical work.

Description: This initiative will provide consultation on statistics, study design, appropriate control groups, sample size, power calculations, randomization, stratification, and analysis. This will include a computer-based data collection, data management, and data quality control system for DMID clinical research studies. The system will be 21 CFR 11 compliant which will be demonstrated by independent audit and will assure accuracy, completeness, and timeliness of data. The current contract includes web-based data entry and computer-based data management functions.

Cooperative Research Partnerships for Biodefense

For the published initiative, see the November 29, 2006, Guide announcement.

Request for Applications

Contact: Michael Schaefer
Phone: 301/496-7728
Internet: mschaefer@niaid.nih.gov

Objective: To support research that will advance development of vaccines, therapeutics, adjuvants, and diagnostics for biodefense and emerging infectious diseases.

Description: Partnerships between researchers from different disciplines and industrial laboratories will be strongly encouraged to facilitate discovery, design, and/or development of new products. Clinical trials will not be supported under this program. Areas of emphasis include:

Therapeutics and Immunotherapeutics: The development of new or improved therapeutics should focus on known targets (including antimicrobial resistance mechanisms) or the identification of new targets based on microbial physiology, immune responses, genomic/proteomic approaches, structural characterization, etc. The design of novel drugs or immunotherapies should include lead compound identification and optimization through reiterative synthesis and evaluation, and pre-clinical efficacy testing in animal models.

Diagnostics: The design and development of rapid, sensitive, and specific diagnostics may focus on previously identified pathogen-specific targets or novel approaches to identify and validate new targets or technologies amenable to large-scale production and validation for clinical diagnosis and point-of-care use.

Vaccines: The development of new or improved vaccines and/or vaccine delivery systems should focus on known specific immunogens or novel approaches to identify new protective antigens and/or their epitopes. These projects are expected to include proof-of-concept in animal models, pre-clinical evaluation, and scale-up production under GMP to provide sufficient quantities for pre-clinical FDA-required animal studies.

Adjuvants: Projects focused on adjuvants should translate emerging advances in the understanding of inductive requirements for specific immune responses to development of new adjuvant forms and strategies. These projects are expected to include strategies for screening adjuvant activity, pre-clinical evaluation, and scale-up production under GMP to provide sufficient quantities for pre-clinical FDA-required animal studies.