Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years
NCT06891417 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1560
Last updated 2026-04-08
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
- 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
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 29 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-27
- Primary Completion
- 2028-01-03
- Completion
- 2028-01-03
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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