Accelerate Diagnostic and Vaccine Development of Bacterial Sexually Transmitted Infections

Through the funding opportunity announcement (FOA) Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STIs) To Accelerate Diagnostic and Vaccine Development (R01, Clinical Trial Not Allowed), NIAID will support studies on the clinical history of three STIs: syphilis, gonorrhea, and chlamydia. The current clinical history gap is a major barrier to diagnostic and vaccine development.

Natural history studies are challenging because these infections must be treated upon diagnosis. Clinical history studies consider the full spectrum of infection and are composed of natural history—infection to screening and the interval after screening from treatment through follow-up exams. Therefore, clinical history studies require creative design to give a full picture of curable infectious diseases.

Research Objectives

For this initiative, investigators should propose studies that could result in new and improved approaches to understanding the clinical history of antibiotic-resistant gonorrhea, syphilis (including congenital syphilis), and chlamydial infections. In 2020, CDC reported 2.4 million cases of chlamydia, gonorrhea, and syphilis (including congenital syphilis) in the United States.

NIAID is interested in the following research areas:

• Longitudinal clinical studies of syphilis after treatment to better understand the decline or persistence of antibodies in response to treatment and collect specimens that inform diagnostic and vaccine development at different stages of disease
• Clinical history of congenital syphilis infection to explore the complexity of the maternal-fetal interface to inform diagnostic approaches
• Linked clinical, phenotypic, and molecular assessments of repeat infection or treatment failure of gonorrhea
• Surrogates of immunity and protection to accelerate gonococcal vaccine development
• Clinical history of infection in the context of the human male and female genital tract
• Pathogenesis and biomarkers that have led to long-term outcomes such as pelvic inflammatory disease
• Mechanisms of immunity for spontaneous clearance of infection to accelerate chlamydia vaccine development

Conversely, NIAID considers applications that include the following research topics to be nonresponsive and will return them unreviewed.

• STIs other than syphilis, gonorrhea, and chlamydia
• HIV/AIDS
• Clinical trials

Budget Information and Deadline

Applicants can request up to $500,000 in annual direct costs. The scope of the proposed project should determine the project period, which should not exceed five years.

Applications are due by 5 p.m. local time of the applicant organization on September 12, 2022.

Contact Information

For inquiries, contact Dr. Leah Vincent at 301-761-7365 or leah.vincent@nih.gov. For peer review-related questions, contact Dr. Frank DeSilva at 240-669-5023 or fdesilva@niaid.nih.gov.