Phase III Study of Acne mRNA Vaccine Safety and Effectiveness in Adults Aged 18 to 45 With Moderate to Severe Acne

What this Trial Is About

Researchers are studying an Acne mRNA vaccine candidate to evaluate its safety, effectiveness, and immune response in adults aged 18 to 45 years with moderate to severe acne. This first-in-human Phase III trial aims to find the best vaccine dose and regimen by testing four different doses and comparing two versus three injections. Acne is a common inflammatory skin disease, and current treatments have not changed much in 30 years, so new options are needed. The trial includes a Core Study with four cohorts two cohorts receive two doses Sentinel Cohort A and Main Cohort A and two cohorts receive three doses Sentinel Cohort B and Main Cohort B. The vaccine or placebo is given by intramuscular injection. After completing the Core Study, some participants will join a Long-Term Extension LTE follow-up lasting up to 30 months to assess lasting effects. Participants in the Main Cohort B may join a separate LTE study. During the study, participants will have medical exams, blood tests, and acne lesion counts. Researchers will monitor adverse events shortly after each injection and for up to 6 or 9 months after. They will measure changes in inflammatory and non-inflammatory acne lesions and antibody levels. Safety assessments include monitoring serious and unexpected reactions. Follow-up visits will continue for months after the last dose to observe long-term safety and immune response.

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