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Natural History of Chlamydia trachomatis genital tract infection in women

Award Number: R01AI170959
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/02/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2028

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Natural History of Chlamydia trachomatis genital tract infection in women - Chlamydia trachomatis is a well-recognized PID pathogen for which no vaccine is available. Women are at risk for reproductive sequelae when infection ascends into the upper reproductive tract, driving inflammatory processes that trigger immune pathology. However, the bacterial and/or host factors that govern ascension and subsequent pathology remain unknown. Our long-term goal is to identify biomarkers that identify women at risk for reproductive morbidity or correlate with protective immunity. We and others have established that susceptibility to human chlamydial genital infection is mediated by pathogen abundance, co-infection, oral contraceptives and cervicovaginal microbiota. The overall objective of this proposal is to identify cervical discriminators of asymptomatic, ascending chlamydial infection and endometritis in women. The central hypothesis is that overall risk for ascending infection is modulated by local host inflammatory responses, pathogen fitness and environmental factors mediated by the cervicovaginal microbiome. Our rationale is that identifying these factors will accelerate rational vaccine design and testing. In a pilot study of women at high risk for STIs, we demonstrated the potential for unbiased characterization of host, pathogen and microbiome interactions using transcriptomics and determined that a single cervical specimen was sufficient to detect clustered host transcriptional profiles reflecting microbiome differences and STI infection. Guided by strong preliminary data and leveraging ongoing NIH funded research, the following four specific aims will test our hypothesis: 1) Profile cervical immune response with respect to ascending infection and susceptibility to reinfection; 2) Profile chlamydial transcriptional activity associated with ascending infection; 3) Profile transcriptionally active microflora in Chlamydia-infected women to determine how these complex microbial communities modulate ascending infection; and 4) Integrate host, pathogen and microbiome responses to determine key pathways controlling outcome. The first aim will profile cervical inflammatory responses and immune cell populations from women with local infection or upper tract involvement in a cohort of highly-exposed women (TRAC2). We will transcriptionally profile the chlamydial strains causing their infections and use metatranscriptomics to characterize the contribution of the cervicovaginal microbiome. Finally, we will use robust biostatistical approaches to improve and expand our understanding of key chlamydia–host interactions that modulate infection outcomes, drive disease and establish protective immunity. The research proposed is innovative, in our opinion, because it will implement a comprehensive, non-biased approach to the identification of molecular biomarkers in a highly disease-relevant clinical population. The proposed research is significant because it is expected to translate directly to anti-chlamydial vaccine evaluation in humans and to have broad importance for diagnosis and for evaluation of novel therapeutics.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $679,850 )
2026	2026	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Allergy and Infectious Diseases Research	000	3	12/24/2025	NON-COMPETING CONTINUATION	$679,850
														Subtotal = $679,850

Issue Date FY: 2025 ( Subtotal = $742,607 )
2025	2025	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Allergy and Infectious Diseases Research	000	2	11/19/2024	NON-COMPETING CONTINUATION	$742,607
														Subtotal = $742,607

Issue Date FY: 2024 ( Subtotal = $777,437 )
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Allergy and Infectious Diseases Research	000	1	1/2/2024	NEW	$701,080
2024	2024	UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL	104 AIRPORT DR STE 2200	CHAPEL HILL	NC	27599	ORANGE	USA	Allergy and Infectious Diseases Research	001	1	9/4/2024	NEW	$76,357
														Subtotal = $777,437

Grand Total All Awards = $2,199,894

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Natural History of Chlamydia trachomatis genital tract infection in women

Award Number: R01AI170959

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/02/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2028

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