None listed
Conditions
Brief summary
The purpose of this study is to generate key data in preparation for the Phase I/II study (safety, immunogenicity and descriptive efficacy proof of concept), and for the global Phase III vaccine efficacy study as part of the Chlamydia vaccine clinical development program. This study will monitor urogenital and extragenital infections or reinfections caused by Chlamydia trachomatis bacteria. Study details It is an observational study, and no vaccine will be administered. This study plans to identify and follow approximately 200 participants Ct NAAT positive from collected urogenital samples for a maximum of 7 months. Females will have vaginal, cervical (optional), oropharyngeal (optional), rectal (optional), and mucosal vaginal secretion (optional) samples collected and males will provide urine, oropharyngeal (optional), rectal (optional), and urethral (optional) samples for the detection of Ct infection. Study duration- The study duration will be variable depending on the baseline Ct infection status and Ct reinfection but will not exceed 7 months. -
Interventions
VAV00007 Study is a prospective longitudinal cohort study of adults aged 18 to 29 years infected with Chlamydia Trachomatis (Ct) bacteria. The purpose of the study is to monitor urogenital and extragenital infections or reinfections caused by Ct.
This is single cohort observational study where approximately 200 Ct NAAT positive participants will be enrolled into the study for an approximate duration of 7 months. Participants will not receive any vaccine in this study. They will be treated wi
VAV00007 Study is a prospective longitudinal cohort study of adults aged 18 to 29 years infected with Chlamydia Trachomatis (Ct) bacteria. The purpose of the study is to monitor urogenital and extragenital infections or reinfections caused by Ct. This is single cohort observational study where approximately 200 Ct NAAT positive participants will be enrolled into the study for an approximate duration of 7 months. Participants will not receive any vaccine in this study. They will be treated with standard of care antibiotic treatment for chlamydia infection. - The study will consist of 1-7 planned visits (Day 1, 8, 45, 105, 112, 195 and 202) and 1-6 planned phone calls (PC) on Day 4, 15, 75, 108, 198 and 150). - Participants will be tested for Ct and NG (Neisseria gonorrhoeae) infection at the enrolment visit (Day 1). -Planned phone calls will involve participant diary review with a delegated study team member and may take approximately 30 minutes to complete. - All enrolled participants will be evaluated for the disease prevalence assessment, but only those with nucleic acid amplification test (NAAT) confirmed Ct infection from collected urogenital samples will continue the study. - They will receive a Ct antibiotic treatment as per standard of care and will be followed over the study duration (6 months) for any subsequent urogenital and extragenital reinfection by Ct. - Antibiotics like Doxithromycin and Azithromycin will be prescribed by delegated investigators as per STI guidelines and standard of care. - All participants will be provided with diary card which will be reviewed by the investigator or designee to review the information on day 15, 45, 75, 105, 108, 11, 150, 195, 198 and 202). - Various samples will be collected on the following visit days. At each visit day, one collection will be performed for blood and urine sample, but vaginal collections may use up to 5 swabs. Blood (Screening, Day 8, 45, 112 and 195); Urine (Screening, Day 1, 8, 45, 105, 112, 195 and 202); Vaginal (Screening, Day 1, 8,45, 105, 112, 195 and 202). Other samples which are optional will be collected as follows. At each visit day, one collection will be performed, but a second swab may be used for urethral collections: Cervical /Urethral (screening, Day 8, 112 and 202); Oropharyngeal and Rectal (Screening, Day 8, 45, 105, Day 105 and 195).
Sponsors
Sanofi Pasteur Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18 to 29 years on the day of inclusion 2 .New sex partner within the past 6 months, or more than one current sex partner, or partner with known sexually transmitted infection (STI), or inconsistent condom use. 3. For persons living with human immunodeficiency virus (HIV): participant with a stable HIV infection determined by a CD4 count greater than 200/mm3, and currently on antiretrovirals for at least 6 months 4. A female participant is eligible to participate if she is not pregnant. A female participant of childbearing potential must have a negative highly sensitive urine pregnancy test at the enrollment visit (V01). 5. Informed consent form has been signed and dated. 6. Able to attend all scheduled visits and to comply with all study procedures
Exclusion criteria
1. Known or suspected congenital immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 2. Unstable acute or chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. 3. For female participants, is menstruating at the time of enrollment visit. Enrollment visit can be postponed until the menstruation period ends. 4. Genital or rectal douching from 48 hours before enrollment visit. Enrollment visit can be postponed until more than 48 hours have passed after the last genital or rectal douching. 5. Documented hysterectomy 6. Receipt of immune globulins, blood or blood-derived products in the past 3 months 7. Receipt of oral or injectable prohibited antibiotic therapy within 21 days prior to enrollment visit (prohibited antibiotics include azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, amoxicillin, ciprofloxacin, tetracycline, and cefixime). Enrollment visit can be postponed until more than 21 days have passed after the last receipt of an antibiotic. 8. Participation at the time of study enrollment (or in the 3 months preceding the enrollment) or planned participation during the present study period in another clinical study investigating a vaccine, or a drug. 9. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. 10. Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
Outcome results
None listed