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RECRUITING
NCT06891417
PHASE1

Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety of two doses (Dose 1 and Dose 2) of Chlamydia mRNA Vaccine candidate in adult participants aged 18 to 29 years (Chlamydia trachomatis seronegative) or 18 to 44 years (Chlamydia trachomatis seropositive). There will also be an assessment to potentially obtain an early immunogenicity signal of the Chlamydia mRNA vaccine candidate. This study will consist of 2 Cohorts assessing the safety of the two different doses: Cohort A (Dose 1 or placebo) and Cohort B (Dose 2 or placebo). 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.

Official title: A Phase 1, Randomized, Placebo-controlled, Multi-arm, Study to Evaluate the Safety of a Chlamydia Trachomatis mRNA Vaccine Candidate in Adults

Key Details

Gender

All

Age Range

18 Years - 44 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-03-27

Completion Date

2027-11-03

Last Updated

2026-11-02

Healthy Volunteers

Yes

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

Locations (7)

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

Investigational Site Number : 0360010

Melbourne, Victoria, Australia