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

Overview

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.

Interventions

• Biological Chlamydia mRNA Vaccine
  Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection
• Other Placebo
  Pharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection

Primary outcome measures

• Presence of immediate unsolicited systemic adverse events (AEs) [Time frame: Within 30 minutes after each vaccine injection]
• Presence of solicited injection site and systemic reactions [Time frame: Up to 7 days after each vaccine injection]
• Presence of unsolicited AEs [Time frame: Up to 28 days after each vaccine injection.]
• Presence of medically attended adverse events (MAAEs) [Time frame: Up to 6 months after last vaccine injection]
• Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs) [Time frame: Up to 12 months after last vaccine injections]
• Presence of related SAEs, and fatal SAEs [Time frame: Throughout the study, appriximatley 18 months]
• Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort) [Time frame: Up to 7 days after each vaccination injections]

Secondary outcome measures (2)

• Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset [Time frame: Before each vaccine injection through 1 month after each vaccine injection]
• 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 [Time frame: Before each vaccine injection through 1 month after each vaccine injection]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Triple blind

Primary purpose

Prevention

Study locations

Australia · 7 centers

• Investigational Site Number : 0360002 — Bruce
• Investigational Site Number : 0360006 — Maroubra
• Investigational Site Number : 0360005 — Sydney
• Investigational Site Number : 0360001 — Albion
• Investigational Site Number : 0360004 — Morayfield
• Investigational Site Number : 0360003 — Southport
• Investigational Site Number : 0360010 — Melbourne

Identifiers

NCT: NCT06891417 · VAV00023 · U1111-1308-7349

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗