protocolSection identificationModule nctId: NCT06316297, orgStudyIdInfo id: VBE00001, secondaryIdInfos id: U1111-1295-3154, type: REGISTRY, domain: ICTRP, briefTitle: Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2027-12-22, completionDateStruct date: 2027-12-23, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US., conditionsModule conditions: Acne, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential and parallel design, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 386, type: ESTIMATED, armsInterventionsModule interventions name: Acne mRNA vaccine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with unsolicited systemic AEs, primaryOutcomes measure: Number of participants with solicited injection site and systemic reactions, primaryOutcomes measure: Number of participants with unsolicited AEs, primaryOutcomes measure: Number of participants with MAAEs, primaryOutcomes measure: Number of patients with SAEs, primaryOutcomes measure: Number of patients with related SAEs, fatal SAEs and AESIs, primaryOutcomes measure: Change in grade from baseline in biological test results, primaryOutcomes measure: Absolute change from baseline in the number of inflammatory acne lesions on face, primaryOutcomes measure: Percentage change from baseline in the number of inflammatory acne lesions on face, primaryOutcomes measure: Absolute change from baseline in the number of non-inflammatory acne lesions on face, primaryOutcomes measure: Percentage change from baseline in the number of non-inflammatory acne lesions on face, primaryOutcomes measure: At least two-grade improvement in IGA scores, secondaryOutcomes measure: Assessment of vaccine-antigen-specific serum antibody titers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: True Blue Clinical Research Site Number : 8400016, status: RECRUITING, city: Brandon, state: Florida, zip: 33511, country: United States, geoPoint lat: 27.9378, lon: -82.28592, locations facility: Jacksonville Center for Clinical Research Site Number : 8400006, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: DelRicht Research Site Number : 8400013, status: RECRUITING, city: New Orleans, state: Louisiana, zip: 70115, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Metro Boston Clinical Partners Site Number : 8400008, status: RECRUITING, city: Brighton, state: Massachusetts, zip: 02135, country: United States, geoPoint lat: 42.3501, lon: -71.15644, locations facility: DermResearch Center of New York, Inc Site Number : 8400010, status: RECRUITING, city: Stony Brook, state: New York, zip: 11790, country: United States, geoPoint lat: 40.92565, lon: -73.14094, locations facility: Lynn Health Science Institute (LHSI) Site Number : 8400004, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73112, country: United States, geoPoint lat: 35.46756, lon: -97.51643, locations facility: Dermresearch Site Number : 8400009, status: RECRUITING, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Center for Clinical Studies, LTD. LLP Site Number : 8400002, status: RECRUITING, city: Houston, state: Texas, zip: 77004, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False