# University of North Carolina - Chlamydia Vaccine Initiative (UNC-CVI)

> **NIH NIH U19** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 · $958,744

## Abstract

C. trachomatis (CT) is the most common sexually transmitted bacterial infection with an estimated 100 million
annual cases worldwide. Arising in the endocervix, in ~10% of infected women CT ascends to the
endometrium and oviducts where it can cause symptomatic or subclinical pelvic inflammatory disease, leading
to chronic pelvic pain, infertility, and ectopic pregnancy. Antibiotic treatment is limited because >70% of
infections are asymptomatic, and women may present for treatment after irreversible oviduct damage has
occurred. The goal of this Sexually Transmitted Infections (STI) Cooperative Research Center (CRC) U19
proposal, “University of North Carolina-Chlamydia Vaccine Initiative (UNC-CVI STI CRC),” is to develop a
novel vaccine that prevents CT ascension in the female genital tract, eliminating CT-associated PID and
infertility. The ultimate goal is to develop a vaccine regimen that fully prevents productive CT infection. To help
achieve these goals, the proposed Clinical Core, based at the University of Pittsburgh, will work closely with
the scientists and staff of Research Project 1 and Research Project 3 to provide the comprehensive clinical
research support needed to, respectively, evaluate CT antigens in women and identify biomarkers of disease
risk or susceptibility during CT infection. The core will conduct thorough, sensitive screening and evaluation of
reproductive-aged women with or at-risk for STIs; safely and efficiently enroll individuals and ensure that
recruitment and retention protocols enroll a diverse clinical population from an array of ethnic and socio-
economic backgrounds for the two projects; collect information and clinical specimens from participants; and
conduct initial laboratory testing of samples for STI pathogens. Achievement of the core’s goals will be
facilitated in three critical ways. One, the core will use the clinical sites and some of the same personnel that
participated in a previous core-supported project, the T Cell Response Against Chlamydia (TRAC) Study of the
University of Pittsburgh STI CRC. These sites -- the Allegheny County Health Department Sexually
Transmitted Diseases Program and the Ambulatory Clinic at Magee-Womens Hospital (both for enrollment),
and the Reproductive Infectious Diseases Research Unit (for follow-up clinical activities, also in Magee-
Womens Hospital) – are a five minutes’ drive apart. Two, the core will employ the recruitment, retention and
data collection procedures from the TRAC Study, which met all recruitment targets and had high retention.
Three, banked samples from TRAC led to preliminary data for this U19 proposal, and they will supplement the
samples to be gathered by the core to complete Projects 1 and 3. The successful recruitment and retention of
UNC-CVI clinical research participants and the data originating from the human samples collected and
distributed by the core to Center scientists will greatly ensure the success of Projects 1 and 3 and will
significan...

## Key facts

- **NIH application ID:** 10149921
- **Project number:** 5U19AI144181-03
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Toni Darville
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $958,744
- **Award type:** 5
- **Project period:** 2019-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10149921

## Citation

> US National Institutes of Health, RePORTER application 10149921, University of North Carolina - Chlamydia Vaccine Initiative (UNC-CVI) (5U19AI144181-03). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10149921. Licensed CC0.

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