drugset / Trial / NCT07013747

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

NCT07013747 ↗

Phase 1/2 Recruiting 228 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2025-07-03
Primary completion
2029-06-19
Completion
2030-03-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Acne mRNA vaccine Messenger RNA (mRNA) — Intramuscular

Indications