Chlamydia mRNA vaccine for young adults
Official title: A Phase 1, Randomized, Placebo-controlled, Multi-arm, Study to Evaluate the Safety of a Chlamydia Trachomatis mRNA Vaccine Candidate in Adults
Run by Sanofi · NCT06891417 · Data updated 2026-11-12
This study is testing a new Chlamydia mRNA vaccine in young adults aged 18 to 29 to see if it is safe and effective.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 7 sites (Bruce, Australian Capital Territory and 6 other locations) |
| Status | Recruiting |
| Started | March 27, 2025 |
| Main results expected | November 3, 2027 |
| Study ends | November 3, 2027 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06891417 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 29 with specific sexual health risk factors, such as new or multiple sex partners or a history of sexually transmitted infections.
✕Probably not a fit
Patients who are not sexually active or do not meet the eligibility criteria related to sexual health risk factors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety, efficacy, and immunogenicity of a Chlamydia mRNA vaccine in adults aged 18 to 29 years. Participants will receive different dose levels of the vaccine, with a focus on assessing safety through three Sentinel Cohorts before moving to a Main Cohort. The study involves follow-up for up to 12 months after the last vaccine administration, making the total duration of participation approximately 18 months.
Why it matters
Potential benefit: If successful, this vaccine could significantly reduce the incidence of Chlamydia infections among young adults.
How similar studies have gone: While there have been studies on vaccines for other sexually transmitted infections, this specific mRNA approach for Chlamydia is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 to 29 years (Chlamydia trachomatis seronegative) or 18 to 44 years (Chlamydia trachomatis seropositive) on the day of inclusion * 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 virus (HCV) Abs infection at screening visit. * Known or suspected congenital or acquired 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). * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances. * Previous history of myocarditis, pericarditis, and/or myopericarditis * Known history of previous history of Guillain-Barre syndrome and other immune mediated demyelinating conditions that include but are not limited to Multiple Sclerosis (MS), Neuromyelitis Optica (NMO), acute disseminated encephalomyelitis (ADEM), Transverse myelitis. * Screening electrocardiogram (ECG) value that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or screening ECG that demonstrates clinically relevant abnormalities, per investigator, that may affect participant safety or study results. * Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion. * Moderate or severe acute febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Receipt of any mRNA vaccine/product in the 2 months preceding study enrollment or planned receipt of any mRNA vaccine/product within the 2 months following any study intervention administration. * Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration, except influenza which may be received at least 2 weeks before or 2 weeks after any study vaccination. * Receipt of immune globulins, blood, or blood-derived products in the past 3 months. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it's running
-
Investigational Site Number : 0360002
Bruce, Australian Capital Territory, Australia Recruiting -
Investigational Site Number : 0360006
Maroubra, New South Wales, Australia Recruiting -
Investigational Site Number : 0360005
Sydney, New South Wales, Australia Recruiting -
Investigational Site Number : 0360001
Albion, Queensland, Australia Recruiting -
Investigational Site Number : 0360004
Morayfield, Queensland, Australia Recruiting -
Investigational Site Number : 0360003
Southport, Queensland, Australia Recruiting
Show 1 more location
-
Investigational Site Number : 0360010
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.