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Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
Sponsor: Sanofi Pasteur, a Sanofi Company
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
Acne mRNA vaccine
Pharmaceutical form: suspension for injection Route of administration: intramuscular
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