RecruitingPhase 1Phase 2NCT07013747

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


Sponsor

Sanofi Pasteur, a Sanofi Company

Enrollment

228 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Acne mRNA vaccine and Placebo for people with acne. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAcne mRNA vaccine

Pharmaceutical form: suspension for injection Route of administration: intramuscular

OTHERPlacebo

Pharmaceutical form: liquid solution for injection Route of administration: intramuscular


Locations(4)

Encino Research Center- Site Number : 8400008

Encino, California, United States

Moore Clinical Research - Brandon- Site Number : 8400007

Brandon, Florida, United States

Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

Jacksonville, Florida, United States

DelRicht Research- Site Number : 8400003

New Orleans, Louisiana, United States

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NCT07013747


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