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RECRUITING
NCT06891417
PHASE1/PHASE2

Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

1560

Start Date

2025-03-27

Completion Date

2028-01-03

Last Updated

2026-04-08

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