Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Mar 12, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new acne vaccine designed to help adults aged 18 to 45 who have moderate to severe acne. The main goals of the study are to see if the vaccine is safe, effective, and able to trigger an immune response in participants. Those who qualify for this study must be generally healthy and have a specific type of acne that meets certain criteria, such as having a certain number of non-inflammatory and inflammatory lesions on their face.

If you decide to participate, you will receive one or two injections of the vaccine, depending on the dose assigned to you. Throughout the study, researchers will monitor your health and the effects of the vaccine. It's important to note that not everyone can join; for instance, individuals with certain medical conditions or those who have recently used specific acne treatments or other vaccines may be excluded. This trial is currently recruiting participants in the U.S., and your involvement could help advance new treatments 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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 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
• • Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
• • Use of any acne-affecting treatment without an appropriate washout period
• • Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
• • Previous vaccination against C. acnes with an investigational vaccine
• • 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.
• • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.