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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,560
Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection
Pharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection
Investigational Site Number : 0360002
Bruce, Australian Capital Territory, Australia
Investigational Site Number : 0360006
Maroubra, New South Wales, Australia
Investigational Site Number : 0360005
Sydney, New South Wales, Australia
Investigational Site Number : 0360001
Albion, Queensland, Australia
Investigational Site Number : 0360004
Morayfield, Queensland, Australia
Investigational Site Number : 0360003
Southport, Queensland, Australia
Presence of immediate unsolicited systemic adverse events (AEs)
Number of participants with immediate unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccine injection.
Time frame: Within 30 minutes after each vaccine injection
Presence of solicited injection site and systemic reactions
Number of participants with solicited injection site and systemic reactions occurring up to 7 days after each vaccine injection.
Time frame: Up to 7 days after each vaccine injection
Presence of unsolicited AEs
Participants with unsolicited AEs reported up to 28 days after each vaccine injection.
Time frame: Up to 28 days after each vaccine injection.
Presence of medically attended adverse events (MAAEs)
Number of participants with MAAEs reported after each vaccine injection and up to 6 months after last vaccine injection.
Time frame: Up to 6 months after last vaccine injection
Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs)
Number of participants with SAEs and all AESIs reported after each vaccine injection and up to 12 months after last vaccine injection
Time frame: Up to 12 months after last vaccine injections
Presence of related SAEs, and fatal SAEs
Number of participants with related SAEs, and fatal SAEs throughout the study
Time frame: Throughout the study, appriximatley 18 months
Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort)
Number of participants with out-of-range biological test results up to 7 days after each vaccine injection
Time frame: Up to 7 days after each vaccination injections
Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset
Binding Immunoglobulin (Ig) will be measured using a multiplex electrochemiluminescent (ECL) based binding assay
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
Geometric mean cell-mediated immune responses will be measured by an intracellular cytokine staining assay over time
Time frame: Before each vaccine injection through 1 month after each vaccine injection
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