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R01AI176999

Project Grant

Overview

Grant Description
The influence of rectal Chlamydia trachomatis infections on immunity and incident urogenital infections in women without an indication for rectal screening - Abstract

Chlamydia trachomatis (CT) infections in the U.S. are increasing and no CT vaccine exists. Annual urogenital tract (UGT) screening of <25 and high-risk women of any age is recommended, but testing for rectal CT infection is not recommended in women without rectal exposure. However, rectal CT prevalence rates are similar in women regardless of anal sex exposures and up to 19% of CT infections occur only in the rectum and would be missed by screening recommendations.

Animal studies suggest that rectal infection is beneficial by inducing potent transmucosal immunity that protects the UGT against reinfection without pathological effects. It is critical that we understand whether rectal CT infections in women are potentially harmful, by cross-contaminating the UGT, or beneficial, by inducing mucosal protection against UGT infection. Further, understanding if rectal CT infections are immunogenic will establish if a mucosal Chlamydia vaccine is feasible.

We will enroll women at high-risk for Chlamydia but who have never engaged in anal sex. Over 12 months, we will (1) obtain monthly oral, vaginal, and rectal swabs to detect incident CT infections, (2) collect quarterly blood and cervical cyto-brush specimens to study systemic and cervical T-cell responses, and (3) capture weekly sexual behavior and symptoms data to screen for exposure and CT-related symptoms.

The goal of this project is to test the hypothesis that (1) rectal CT infections are frequent, long-lasting, asymptomatic, associated with specific rectal-tropic strains, and do not increase risk for UGT infection (Aim 1) and (2) assess their influence on systemic and cervical memory T-cell immunity and if they decrease incident UGT infections (Aim 2). By understanding if rectal CT infections increase or decrease UGT infection risk, these studies may change screening guidelines and lay the foundation for development of an oral attenuated Chlamydia vaccine.
Funding Goals
NOT APPLICABLE
Place of Performance
Indianapolis, Indiana 46202 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 306% from $770,933 to $3,132,062.
Trustees Of Indiana University was awarded Rectal CT Infections & UGT Immunity in Women Project Grant R01AI176999 worth $3,132,062 from the National Institute of Allergy and Infectious Diseases in July 2023 with work to be completed primarily in Indianapolis Indiana United States. The grant has a duration of 5 years and was awarded through assistance program 93.855 Allergy and Infectious Diseases Research. The Project Grant was awarded through grant opportunity Understanding the Clinical History of Bacterial Sexually Transmitted Infections (STI) to Accelerate Diagnostic and Vaccine Development (R01 Clinical Trial Not Allowed).

Status
(Ongoing)

Last Modified 7/20/26

Period of Performance
7/6/23
Start Date
6/30/28
End Date
66.0% Complete

Funding Split
$3.1M
Federal Obligation
$0.0
Non-Federal Obligation
$3.1M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01AI176999

Transaction History

Modifications to R01AI176999

Additional Detail

Award ID FAIN
R01AI176999
SAI Number
R01AI176999-3327249398
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Funding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Awardee UEI
SHHBRBAPSM35
Awardee CAGE
434D9
Performance District
IN-07
Senators
Todd Young
Mike Braun

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Health and Human Services (075-0885) Health research and training Grants, subsidies, and contributions (41.0) $770,933 100%
Modified: 7/20/26