Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis (URSAFE-CT)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anne Van Caesbroeck
- Numéro de téléphone: +32 476 01 48 43
- E-mail: anne.vancaesbroeck@uantwerpen.be
Lieux d'étude
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Antwerp
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Antwerp, Antwerp, Belgique, 2000
- Recrutement
- Violett Antwerp
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Contact:
- Ward Bauwens, MD
- Numéro de téléphone: +32 3 293 95 91
- E-mail: info@violett.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Concentration of total and Chlamydia-specific immunoglobulins in first-void urine and serum samples
Délai: 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
Délai: Within 6 months after study completion
|
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.
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
STI DNA status of first-void urine and vaginal brush samples.
Délai: Within 6 months after study completion.
|
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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Infections
- Maladies transmissibles
- Maladies sexuellement transmissibles
- Infections bactériennes
- Infections bactériennes et mycoses
- Infections bactériennes à Gram négatif
- Infections à Chlamydiacées
- Maladies sexuellement transmissibles, bactériennes
- Infections à Chlamydia
Autres numéros d'identification d'étude
- B3002025000147
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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