Clinical Trial

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

Recruiting Phase 1/2
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Summary
The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-06-02; most recent amendment 2026-07-08.
Status change: Not Yet Recruiting → Recruiting 2025-07-09
Trial Details
NCT Number NCT07013747
Lead Sponsor Sanofi Pasteur, a Sanofi Company
Conditions Acne
Enrollment 228 participants
Start Date 2025-07-03
Primary Completion 2029-06-19 (estimated)
Study Completion 2030-03-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-09