The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Timeframe: 30 minutes after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Timeframe: Up to 7 days after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Timeframe: Up to 28 days after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Timeframe: Up to 6 months after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with SAEs
Timeframe: Up to 6 months after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Timeframe: Up to 6 months after each administration
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Timeframe: Through 7 days after administration (Day 8)
Trial Transparency email recommended (Toll free for US & Canada)
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Timeframe: At 2 months post last administration
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Timeframe: At 2 months post last administration
Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Timeframe: At 2 months post last administration
Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Timeframe: Up to 38 or 40 months after first administration