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New treatment option for Chlamydia Trachomatis Immunization
Official title Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
ClinicalTrials.gov ID: NCT06891417
What this study is testing
What is Chlamydia mRNA Vaccine?
Chlamydia mRNA Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for chlamydia trachomatis immunization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 29. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- Any screening laboratory parameter with laboratory abnormalities as per local reference range and that are greater than Grade 2 or deemed clinically...
- 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...
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation...
- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s)...
- Previous history of myocarditis, pericarditis, and/or myopericarditis
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical...
The study team makes the final eligibility decision.
Where it's taking place
- Bruce, Australian Capital Territory, Australia
- Maroubra, New South Wales, Australia
- Sydney, New South Wales, Australia
- Albion, Queensland, Australia
- Morayfield, Queensland, Australia
- Southport, Queensland, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 29 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruce, Australian Capital Territory, Australia; Maroubra, New South Wales, Australia; Sydney, New South Wales, Australia; Albion, Queensland, Australia; Morayfield, Queensland, Australia; Southport, Queensland, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.