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RECRUITING
NCT07013747
PHASE1/PHASE2

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-07-03

Completion Date

2029-06-19

Last Updated

2025-09-05

Healthy Volunteers

No

Conditions

Interventions

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

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