Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years (NCT06891417) | Clinical Trial Compass
RecruitingPhase 1/2
Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
Australia1,560 participantsStarted 2025-03-27
Plain-language summary
The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of different dose levels (low, medium, and high) of Chlamydia messenger ribonucleic acid (mRNA) Vaccine candidate in adult participants aged 18 to 29 years.
This study will consist of 3 Sentinel Cohorts and a Main Cohort, with the Sentinel Cohorts assessing the safety of the different dose levels in a stepwise manner.
All participants will be followed up to 12 months after the last study intervention administration. Thus, the expected duration of the participant's involvement will be 18 months.
Who can participate
Age range
18 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 to 29 years on the day of inclusion
* New sex partner within the past 6 months, or more than one current sex partner, or partner with known previous or coexisting sexually transmitted infection (STI), or inconsistent condom use
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be surgically sterile.
OR
• Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to study intervention administration until at least 4 weeks after the last study intervention administration.
* A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at the screening visit and before each subsequent study intervention administration
Exclusion Criteria:
* Any screening laboratory parameter with laboratory abnormalities as per local reference range and that are greater than Grade 2 or deemed clinically significant in the opinion of the Investigator
* Participants who are Chlamydia trachomatis (CT) and/or Neisseria gonorrhea (NG) NAAT positive at screening visit
* Self-reported or documented seropositivity for HIV antigen and/or antibodies (Abs), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibodies (HBcAbs), or hepatitis C vir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of immediate unsolicited systemic adverse events (AEs)
Timeframe: Within 30 minutes after each vaccine injection
2
Presence of solicited injection site and systemic reactions
Timeframe: Up to 7 days after each vaccine injection
3
Presence of unsolicited AEs
Timeframe: Up to 28 days after each vaccine injection.
4
Presence of medically attended adverse events (MAAEs)
Timeframe: Up to 6 months after last vaccine injection
5
Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs)
Timeframe: Up to 12 months after last vaccine injections
6
Presence of related SAEs, and fatal SAEs
Timeframe: Throughout the study, appriximatley 18 months
7
Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort)
Trial details
NCT IDNCT06891417
SponsorSanofi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-01-03
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)