Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversiteit Antwerpen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy (self-reported)
Being positive for Human Immunodeficiency Virus (HIV)
Women that underwent hysterectomy.
Menstruation at the time of sample collection.
Trial population
A total of 73 Chlamydia positive female participants will be included.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Sampling
DeviceCollection 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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 6 months after study completion2
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.
Time frame
Within 6 months after study completion3
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
Time frame
Within 6 months after study completion.Secondary outcomes
1
STI DNA status of first-void urine and vaginal brush samples.
Nuclear acid amplification test for the presence of DNA from different sexually transmitted infections (including Chlamydia, Mycoplasma genitalium, Mycoplasma hominis, Neisseria gonorrhea, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum) to investigate Chlamydia clearance or persistent infection and determine coinfections.
Time frame
Within 6 months after study completion.2
Other biomarkers
To test other biomarkers to normalize immune biomarkers measured in primary outcomes (antibody or cellular immune responses), for example total IgG, IgG subclasses, total protein, total human DNA etc.
Time frame
Within 6 months after study completion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiteit Antwerpen
Lead sponsor
Violett Antwerp
Collaborator
Source ClinicalTrials.gov