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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Jun 2, 2025

Keywords

ClinConnect Summary

The VBE00009 study is a clinical trial designed to test a new vaccine aimed at treating mild acne in adults aged 18 to 45. The main goals of this study are to find out if the vaccine is safe, effective, and able to trigger a strong immune response against acne. Participants will receive the vaccine in two doses, and the study will begin with a smaller group to carefully monitor safety before including more people.

To be eligible for the study, participants must be generally healthy and have mild facial acne, which is defined as having a specific number of acne lesions. However, individuals with certain health conditions, such as those with weakened immune systems or serious allergies, may not be able to participate. If you join the trial, you can expect to undergo some health evaluations and receive the vaccine, along with regular check-ins to see how you respond. This study is not currently recruiting participants, but it aims to provide valuable insights into a new treatment option for acne.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • IGA score of mild (grade 2 on the 5-grade IGA scale) AND
• • between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
• • between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
• • no nodulocystic lesions (ie, nodules and cysts)
• Exclusion Criteria:
• Participants are excluded from the study if any of the following criteria apply:
• • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• • Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol \[PEG\], polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID 19) vaccine
• • Previous history of myocarditis and/or pericarditis and/or myopericarditis
• • Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
• • Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
• • Receipt of immune globulins, blood or blood-derived products in the past 3 months
• • Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus