NIAID seeks applicants who can develop advanced vaccines for STI pathogens that have limited candidates in the product development pipeline through the new request for applications (RFA) Sexually Transmitted Infections (STI) Cooperative Research Centers (CRC) Vaccine Development (U01, Clinical Trial Not Allowed).
Research Objectives
The goal of this RFA is to identify and support feasible vaccine candidates, regardless of source. While NIAID’s Division of Microbiology and Infectious Diseases has made substantial investment in STI vaccine development, this initiative will focus on advanced vaccine development for STI pathogens that have limited candidates in the product development pipeline: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum.
For your application, you will need to provide a Product Development Strategy (PDS) in addition to a Research Plan. The PDS should discuss Milestones and Timelines for product development; the intended use/indication of the proposed product; and the value of the product compared to existing products. The PDS may look beyond those planned activities described in the Research Plan, which is constrained by the RFA’s budget and project period limitations.
Though not required, we strongly encourage you to partner with relevant industry expertise as you develop your application and, if successful, collaborate on the performance of the research project (e.g., establish a subaward). An industry partner can provide knowledge of product development planning, product profile development, and regulatory matters. Consider retaining such support through defined personnel effort or plan for periodic consultation on specific issues.
Below are examples of advanced vaccine development activities that align with NIAID’s research areas of interest:
- Toxicology
- Clinical assay development
- Formulation
- Process development and control assays
- Good manufacturing practice
Additionally, avoid proposing the following research areas in your application or NIAID will consider the application nonresponsive and not review it:
- Vaccine development for pathogens other than: Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum
- HIV/AIDS-related research
- Clinical trials—refer to NIH’s Definition of a Clinical Trial
Budget Information and Deadline
Application budgets should not exceed $1.4 million in annual direct costs and should reflect the actual needs of the project. The scope of the proposed project should determine the project period which cannot exceed 5 years.
Applications are due on June 14, 2023, by 5 p.m. local time of the applicant organization.
Contact Information
Direct any inquiries to NIAID’s scientific/research contact, Dr. Thomas Hiltke, at thiltke@mail.nih.gov or 240-627-3275. Direct any peer review inquiries to Dr. Scott Jakes at scott.jakes@nih.gov or 240-220-1737.