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Chlamydia mRNA Vaccine

Phase 1

Chlamydia Trachomatis Immunization | Monoclonal antibody | Other |Sanofi|Last Updated: Apr 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,560
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06891417Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 YearsPHASE1 RECRUITING 1,560 — — Mar 27, 2025Jan 3, 2028Apr 8, 20267 Australia
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Study Endpoints
Primary Endpoints
Presence of immediate unsolicited systemic adverse events (AEs)
Within 30 minutes after each vaccine injection

Number of participants with immediate unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccine injection.

Presence of solicited injection site and systemic reactions
Up to 7 days after each vaccine injection

Number of participants with solicited injection site and systemic reactions occurring up to 7 days after each vaccine injection.

Presence of unsolicited AEs
Up to 28 days after each vaccine injection.

Participants with unsolicited AEs reported up to 28 days after each vaccine injection.

Presence of medically attended adverse events (MAAEs)
Up to 6 months after last vaccine injection

Number of participants with MAAEs reported after each vaccine injection and up to 6 months after last vaccine injection.

Presence of all serious AEs (SAEs) and all adverse events of special interest (AESIs)
Up to 12 months after last vaccine injections

Number of participants with SAEs and all AESIs reported after each vaccine injection and up to 12 months after last vaccine injection

Presence of related SAEs, and fatal SAEs
Throughout the study, appriximatley 18 months

Number of participants with related SAEs, and fatal SAEs throughout the study

Presence of out-of-range biological test results (Sentinel Cohort and Safety Subset of Main Cohort)
Up to 7 days after each vaccination injections

Number of participants with out-of-range biological test results up to 7 days after each vaccine injection

Secondary Endpoints
Assessment of serum binding antibodies to specific Chlamydia trachomatis antigens and whole bacteria in immunogenicity subset
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
Before each vaccine injection through 1 month after each vaccine injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Sentinel Cohort A Group 1: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three low dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort B Group 2: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three medium dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort C Group 3: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three high dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort A, B and C Group 4: Chlamydia trachomatis SeronegativePLACEBO_COMPARATORParticipants will receive three injections of Placebo
Sentinel Cohort A Group 5: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three low dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort B Group 6: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three medium dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort C Group 7: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three medium dose injections of Chlamydia mRNA Vaccine
Sentinel Cohort A, B and C Group 8: Chlamydia trachomatis SeropositivePLACEBO_COMPARATORParticipants will receive three injections of Placebo
Main Cohort Group 9: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three low dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 10: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three medium dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 11: Chlamydia trachomatis SeronegativeEXPERIMENTALParticipants will receive three high dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 12: Chlamydia trachomatis SeronegativePLACEBO_COMPARATORParticipants will receive three injections of Placebo
Main Cohort Group 13: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three low dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 14: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three medium dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 15: Chlamydia trachomatis SeropositiveEXPERIMENTALParticipants will receive three high dose injections of Chlamydia mRNA Vaccine
Main Cohort Group 16: Chlamydia trachomatis SeropositivePLACEBO_COMPARATORParticipants will receive three injections of Placebo
Interventions
NameTypeDescription
Chlamydia mRNA VaccineBIOLOGICALPharmaceutical Form: Suspension for injection Route of Administration: Intramuscular injection
PlaceboOTHERPharmaceutical Form: Solution for injection Route of Administration: Intramuscular injection
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Eligibility Criteria
Age Range18 Years — 29 Years
SexALL
Healthy VolunteersYes
Study Sites7

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 par...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06891417Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 24, 2026NCT06891417studyFirstPostDate: changed