Actively Recruiting
Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
Led by Sanofi · Updated on 2026-04-08
1560
Participants Needed
7
Research Sites
144 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Female participants must not be pregnant or breastfeeding
- Female participants of non-childbearing potential must be surgically sterile
- Female participants of childbearing potential must agree to use effective contraception from 4 weeks before the first study intervention until 4 weeks after the last intervention
- Female participants of childbearing potential must have a negative pregnancy test at screening and before each study intervention
You will not qualify if you...
- Laboratory abnormalities greater than Grade 2 or clinically significant at screening
- Positive test for Chlamydia trachomatis or Neisseria gonorrhea at screening
- HIV, hepatitis B, or hepatitis C infection at screening
- Known or suspected immunodeficiency or recent immunosuppressive therapy
- Known severe allergic reaction to study vaccine components
- History of myocarditis, pericarditis, or myopericarditis
- History of Guillain-Barre syndrome or other immune-mediated demyelinating diseases
- Abnormal screening ECG indicating possible myocarditis or other safety concerns
- Thrombocytopenia or bleeding disorders contraindicating intramuscular injection
- Chronic illness that may interfere with study completion
- Moderate or severe fever (≥38.0°C) on day of intervention
- Alcohol, drug, or substance abuse interfering with study
- Receipt of any mRNA vaccine within 2 months before enrollment or planned within 2 months after study intervention
- Receipt of any vaccine other than study vaccine within 4 weeks before or after intervention, except influenza vaccine with specific timing
- Receipt of immune globulins or blood products within past 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Investigational Site Number : 0360002
Bruce, Australian Capital Territory, Australia, 2617
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2
Investigational Site Number : 0360006
Maroubra, New South Wales, Australia, 2035
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3
Investigational Site Number : 0360005
Sydney, New South Wales, Australia, 2010
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4
Investigational Site Number : 0360001
Albion, Queensland, Australia, 4010
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5
Investigational Site Number : 0360004
Morayfield, Queensland, Australia, 4506
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6
Investigational Site Number : 0360003
Southport, Queensland, Australia, 4222
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7
Investigational Site Number : 0360010
Melbourne, Victoria, Australia, 3000
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
16
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