Clinical trial NCT06891417: Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
Official title: A Phase 1/2, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Immunogenicity, and Efficacy of a Chlamydia Trachomatis mRNA Vaccine Candidate in Adults Aged 18 to 29 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Chlamydia Trachomatis Immunization
Keywords: Chlamydia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential (Phase 1) / parallel (Phase 2), dose finding, multi center
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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 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

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Presence of immediate unsolicited systemic adverse events (AEs)
timeFrame: Within 30 minutes after each vaccine injection
measure: Presence of solicited injection site and systemic reactions
timeFrame: Up to 7 days after each vaccine injection
measure: Presence of unsolicited AEs
timeFrame: Up to 28 days after each vaccine injection.
measure: Presence of medically attended adverse events (MAAEs)
timeFrame: Up to 6 months after last vaccine injection
measure: Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs)
timeFrame: Up to 12 months after last vaccine injections
measure: Presence of related SAEs, and fatal SAEs
timeFrame: Throughout the study, appriximatley 18 months
measure: Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort)
timeFrame: Up to 7 days after each vaccination injections
Secondary outcomes:
measure: Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset
timeFrame: Before each vaccine injection through 1 month after each vaccine injection
measure: Geometric mean cell-mediated immune response of antigen-specific T helper type 1 (Th1) and T helper type 2 (Th2) cytokine-producing T cells by phenotype
timeFrame: Before each vaccine injection through 1 month after each vaccine injection
Other outcomes:
Locations:
city: Albion
country: Australia
facility: Investigational Site Number : 0360001
Study officials:
References: