NCT06891417

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,560 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chlamydia Trachomatis Immunization

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-27
• Primary completion: 2028-01-03
• Completion: 2028-01-03
• First posted: 2025-03-24
• Last updated: 2026-04-08

Locations

7 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study