Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis (URSAFE-CT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
To date, clinician-collected blood samples are still the primary methods to monitor immune responses to genital tract infections. Replacing these samples with a specimen that is non-invasive and can be self-collected, such as the initial or first-void urine stream or vaginal brushes, could have important acceptance and feasibility advantages and could facilitate the logistics of clinical trials and future epidemiological or vaccine studies. Moreover, these local samples give more information on the immune response at the site of infection, in the genital tract. Initial results of experiments using first-void urine samples and cervicovaginal brushes for immune response monitoring are promising. However, no standardized method for the detection of (functional) Chlamydia trachomatis (CT)-specific immune responses is available to be used on first-void urine or vaginal samples. Therefore, the aim of this pilot study is to determine feasibility to detect mucosal immune responses in first-void urine and self-collected vaginal samples. Furthermore, we will compare local immune responses with systemic immunity.
The primary objectives of this study are:
- To explore the feasibility to detect (functional) CT-specific antibodies and CT-specific cellular immune responses in first-void urine or self-collected vaginal samples.
- To compare levels of total and CT-specific antibodies in first-void urine and serum.
- To compare mucosal and systemic CT-specific cellular immune responses in mucosal mononuclear cells derived from first-void urine or self-collected vaginal samples, and peripheral blood mononuclear cells (PBMCs).
A total of 73 female participants will be included in this trial. Women that can be included have to be positive for a Chlamydia trachomatis nuclear acid amplification test (NAAT) on a vaginal or FVU sample, and have not yet been treated with antibiotic therapy.
The study described is a low-interventional observational study. Participants will self-collect a first-void urine sample using a 20 mL Colli Pee® device (Novosanis), followed by a vaginal brush (Evalyn® brush, Rovers). Medical personnel at the study site will collect a blood sample (one serum tube and 2 heparin tubes). Furthermore, personal data is collected via a paper-based questionnaire.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Anne Van Caesbroeck
- Numero di telefono: +32 476 01 48 43
- Email: anne.vancaesbroeck@uantwerpen.be
Luoghi di studio
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Antwerp
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Antwerp, Antwerp, Belgio, 2000
- Reclutamento
- Violett Antwerp
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Contatto:
- Ward Bauwens, MD
- Numero di telefono: +32 3 293 95 91
- Email: info@violett.be
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples
Lasso di tempo: Within 6 months after study completion
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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.
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Within 6 months after study completion
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Number of Chlamydia-specific SFCs per million cells
Lasso di tempo: Within 6 months after study completion
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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.
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Within 6 months after study completion
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Measurement of percentage and median fluorescence intensity (MFI) of immune cell subsets in blood, first-void urine and vaginal brush samples.
Lasso di tempo: Within 6 months after study completion.
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Measuring percentage and MFI of immune cell subsets using flow cytometry
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Within 6 months after study completion.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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STI DNA status of first-void urine and vaginal brush samples.
Lasso di tempo: Within 6 months after study completion.
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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.
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Within 6 months after study completion.
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Other biomarkers
Lasso di tempo: Within 6 months after study completion.
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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.
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Within 6 months after study completion.
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Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B3002025000147
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