NIH/NIAID – Control of Sexually Transmitted Infections (STIs) Through a Comprehensive Understanding of the Natural History of Infection (R01 Clinical Trial Not Allowed)

December 3, 2018 by School of Medicine Webmaster

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research to advance the understanding of natural history of infection for three sexually transmitted infections (STIs): gonorrhea, syphilis, and chlamydia. This research opportunity encourages studies that address the natural history of infection in the context of either: 1) correlates of protection, 2) host response to infection, 3) clinical endpoints of disease, or 4) biological and clinical factors that influence clearance rather than persistence of infection.


Currently, the World Health Organization (WHO) estimates an incidence of 357 million cases of curable STIs annually. The jointly developed WHO-NIAID STI Vaccine Roadmap has identified gonorrhea, syphilis, and chlamydia as key targets for vaccine development to address this global problem.

A gap in knowledge of natural history studies is routinely documented as a major barrier to vaccine development. This gap has been identified in a variety of publications and workshops such as the  WHO-NIAID Technical Consultation on STI Vaccines, the NIAID DMID Workshop entitled Gonorrhea Vaccines: The Way Forward, the NIAID DMID Workshop entitled Chlamydia Vaccines: The Way Forward, and the NIAID DMID/DAIDS Workshop on Development of a Syphilis Vaccine.

Key gaps identified include a need for better data on the natural history of infection, the burden of sequelae and a need to apply newer technology to these studies; for example, ‘omics–level approaches to differentiate between protective and pathogenic host responses. Currently, there is a lack of a comprehensive review of older studies, but with even a modest search, very little is identified in the literature. In addition, biomarker identification from natural history studies is essential for development of new diagnostics, especially for complex infections such as syphilis.

Research Objectives

This FOA is designed to encourage the research community to develop new approaches to address key challenges, such as how to effectively conduct natural history studies and to consider revisiting the approach of past studies using newer technologies. Some of the key questions that this might answer include: 1) what is the role of natural immunity in protection from these infections, and 2) are people responding to key target candidate vaccine antigens?

To advance an understanding and address gaps identified by the STI research community, a renewed interest in natural history research would directly complement other ongoing efforts in NIAID, as well as those being pursued by public health and industry partners, to develop new diagnostics and vaccines to identify, control and prevent STIs. Examples of research topics include, but are not limited to:

  • Clinical studies to better understand the natural history of infection and the burden of sequelae, particularly for vulnerable populations
  • Natural history studies to inform mechanisms of immunity ( i.e., biological clearance vs. persistence of infection)
  • Studies to determine human immune responses to various antigens that could be vaccine or diagnostic candidates
  • Studies of clinical cohorts to utilize “omics”- type approaches for the study of protective and pathogenic host responses
  • Studies of the clinical endpoints of disease
  • Clinical studies to determine correlates of protection
  • Studies that advance the development of better vaccines, therapeutics, and diagnostics through a better understanding of disease

This FOA will NOT support applications that focus on HIV/AIDS.

Deadlines:  standard dates apply


Filed Under: Funding Opportunities