Clinical trial Recruiting at 7 sites Phase 1 Interventional Ages 18 to 44

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

PhasePhase 1
Study typeInterventional
Ages18 Years to 44 Years
SexAll
Enrollment80 (estimated)
SponsorSanofi
Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations7 sites (Bruce, Australian Capital Territory and 6 other locations)
StatusRecruiting
StartedMarch 27, 2025
Main results expectedNovember 3, 2027
Study endsNovember 3, 2027
Registry record updatedNovember 2, 2026
Trial IDNCT06891417 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.