NCT07013747

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

A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne

Interventions

Type	Name	Description
BIOLOGICAL	Acne mRNA vaccine	Pharmaceutical form: suspension for injection Route of administration: intramuscular
OTHER	Placebo	Pharmaceutical form: liquid solution for injection Route of administration: intramuscular

Timeline

• Start date: 2025-07-03
• Primary completion: 2029-06-19
• Completion: 2029-06-19
• First posted: 2025-06-10
• Last updated: 2025-09-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study