Actively Recruiting
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
Led by Sanofi Pasteur, a Sanofi Company · Updated on 2025-09-05
120
Participants Needed
4
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
- Clinical diagnosis of mild facial acne vulgaris with an IGA score of mild (grade 2 on the 5-grade IGA scale)
- Between 10 to 24 non-inflammatory lesions (open and closed comedones)
- Between 5 to 19 inflammatory lesions (papules and pustules)
- No nodulocystic lesions (nodules and cysts)
You will not qualify if you...
- Known or suspected congenital or acquired immunodeficiency
- Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to first study intervention
- Long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any study intervention components (e.g., polyethylene glycol [PEG], polysorbate)
- History of life-threatening reaction to study interventions or products containing the same substances
- Any allergic reaction (e.g., anaphylaxis) after administration of mRNA COVID-19 vaccine
- Previous history of myocarditis and/or pericarditis and/or myopericarditis
- Skin conditions that could interfere with study evaluation or require interfering therapy
- Excessive facial hair, facial tattoos, facial skin disorders, skin reactions interfering with study assessments
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Self-reported or documented HIV, hepatitis B virus, or hepatitis C virus seropositivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Encino Research Center- Site Number : 8400008
Encino, California, United States, 91436
Actively Recruiting
2
Moore Clinical Research - Brandon- Site Number : 8400007
Brandon, Florida, United States, 33511
Actively Recruiting
3
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, United States, 32216
Actively Recruiting
4
DelRicht Research- Site Number : 8400003
New Orleans, Louisiana, United States, 70115
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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