Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000274572
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of Chlamydia trachomatis infection and reinfection in young adults
Scientific title
A multi-center, prospective, longitudinal cohort study of Chlamydia trachomatis infection and reinfection in adults aged 18 to 29 years.
Secondary ID [1] 311123 0
VAV00007
Universal Trial Number (UTN)
U1111-1294-8340
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infection 332282 0
Condition category
Condition code
Infection 328996 328996 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).















Intervention code [1] 327569 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336788 0
This is a composite primary outcome to assess the baseline prevalence of asymptomatic and symptomatic Ct infection
Timepoint [1] 336788 0
Blood, urine, vaginal, cervical, oropharyngeal, rectal and urethral samples will be collected at multiple timepoints as below.

- Blood samples - screening, Day 8, 45, 112 and 195 from day of enrolment.
- Urine sample (only male) on screening, Day 1, 8, 45, 105, 112, 195 and 202 from the day of enrolment.
- Urethral sample (only male) on screening, Day 8, 112 and 202 from the day of enrolment.
- Vaginal sample (only female) on screening, Day 1, 8,45, 105, 112, 195 and 202 from the day of enrolment.
- Cervical (only female) on screening, Day1, 8, 112 and 202 from the day of enrolment.
- Oropharyngeal and Rectal (both male and female) on screening, Day 8, 45, 105, Day 105 and 195 from the day of enrolment.

Secondary outcome [1] 429671 0
To assess the incidence of asymptomatic and symptomatic Ct reinfection, will be assessed as a composite secondary outcome
Timepoint [1] 429671 0
At the scheduled 3 month and 6-month follow-up visits (day 105 and day 195 from the date of enrolment), or at any unscheduled visit based on signs and symptoms.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2024
Date of last participant enrolment
Anticipated
22/04/2024
Actual
Date of last data collection
Anticipated
11/12/2024
Actual
Sample size
Target
200
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315381 0
Commercial sector/Industry
Name [1] 315381 0
Sanofi Pasteur Inc.
Country [1] 315381 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur Inc.
Address
Discovery Drive, Swiftwater, PA 18370-0187, USA
Country
United States of America
Secondary sponsor category [1] 317442 0
Commercial sector/Industry
Name [1] 317442 0
Sanofi-Aventis Australia Pty Ltd
Address [1] 317442 0
Talavera Corporate Centre, Building D, 12-24 Talavera Rd, Macquarie Park, NSW 2113
Country [1] 317442 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314298 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314298 0
Bellberry HREC: 123 Glen Osmond Rd, Eastwood SA 5063.
Ethics committee country [1] 314298 0
Australia
Date submitted for ethics approval [1] 314298 0
13/12/2023
Approval date [1] 314298 0
31/01/2024
Ethics approval number [1] 314298 0
2023-12-1498

Summary
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. -
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131106 0
Dr Nischal Sahai
Address 131106 0
Dr.Nischal Sahai, University of Sunshine Coast, Southbank, Building A1, SW1 Complex 32 Cordelia street, South Brisbane QLD 4101
Country 131106 0
Australia
Phone 131106 0
+61 07 5456 3978
Fax 131106 0
Email 131106 0
nsahai@usc.edu.au
Contact person for public queries
Name 131107 0
Mrs Melanie Gentgall
Address 131107 0
Translational Science Hub 37 Kent St, Wolloongabba, QLD 4102
Country 131107 0
Australia
Phone 131107 0
+61 400 865 758
Fax 131107 0
Email 131107 0
Melanie.Gentgall@sanofi.com
Contact person for scientific queries
Name 131108 0
Dr Claudia.Gonzalez
Address 131108 0
Translational Science Hub 37 Kent St, Wolloongabba, QLD 4102
Country 131108 0
Australia
Phone 131108 0
+61 497543778
Fax 131108 0
Email 131108 0
Claudia.Gonzalez2@sanofi.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.