Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis

NCT07596316 | Recruiting

• 1 other identifier: B3002025000147
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if we can identify immune biomarkers in first-void urine and vaginal brush samples in Chlamydia trachomatis (CT) positive adult women. Participants will self-collect a first-void urine sample, self-collect a vaginal brush, and a blood sample will be collected by a healthcare worker. Participants will complete a questionnaire.

Conditions

Chlamydia Trachomatis Genital Infection

Keywords

first-void urine; Colli Pee; Chlamydia; Mucosal immunity

Outcome Measures

Primary Outcomes (3)

• Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples

  Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples determined using ELISA-based assays and the correlation of antibody titers between both sample types.

  Within 6 months after study completion

• Number of Chlamydia-specific SFCs per million cells

  Quantification of antigen-specific cells in cells isolated from first-void urine samples, vaginal brush samples and whole blood samples (PBMC) using ELISpot-based assays.

  Within 6 months after study completion

• Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, first-void urine and vaginal brush samples.

  Measuring percentage and MFI of immune cell subsets using flow cytometry

  Within 6 months after study completion.

Secondary Outcomes (2)

• STI DNA status of first-void urine and vaginal brush samples.

  Within 6 months after study completion.

• Other biomarkers

  Within 6 months after study completion.

Interventions

Sampling DEVICE

Collection of first-void urine (i.e. the initial stream of urine) with the Colli-Pee device (Novosanis, Belgium) (one sample of approx. 20 mL). Collection of a vaginal brush sample with the Evalyn brush (Rovers Medical Devices, The Netherlands). Collection of blood samples (three blood tubes of approx. 9 mL).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 73 Chlamydia positive female participants will be included.

You may qualify if:

• Female
• Chlamydia trachomatis NAAT positive vaginal sample or first-void urine sample.
• Able to understand the information brochure and what the study is about.
• Willing to give informed consent to use their samples for details described in the study protocol.

You may not qualify if:

• Pregnancy (self-reported)
• Being positive for Human Immunodeficiency Virus (HIV)
• Women that underwent hysterectomy.
• Menstruation at the time of sample collection.
• Current use of antibiotics effective against Chlamydia trachomatis (doxycyline or azithromycine) or use of such antimicrobials in the past 14 days before participating in the study.
• Participating in another clinical trial at the same time of participating in this study.
• Having a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Violett Antwerp: collaborator

Study Sites (1)

Violett Antwerp

Antwerp, Antwerp, 2000, Belgium

RECRUITING

MeSH Terms

Conditions

Chlamydia Infections

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Anne Van Caesbroeck

CONTACT

+32 476 01 48 43; anne.vancaesbroeck@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

BE (1)