nctId: NCT06316297 id: VBE00001 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 overallStatus: RECRUITING date: 2024-04-05 date: 2027-12-22 date: 2027-12-23 date: 2024-03-18 date: 2024-04-26 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY 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. conditions: Acne studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential and parallel design primaryPurpose: TREATMENT 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 count: 386 type: ESTIMATED name: Acne mRNA vaccine name: Placebo measure: Number of participants with unsolicited systemic AEs measure: Number of participants with solicited injection site and systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with MAAEs measure: Number of patients with SAEs measure: Number of patients with related SAEs, fatal SAEs and AESIs measure: Change in grade from baseline in biological test results measure: Absolute change from baseline in the number of inflammatory acne lesions on face measure: Percentage change from baseline in the number of inflammatory acne lesions on face measure: Absolute change from baseline in the number of non-inflammatory acne lesions on face measure: Percentage change from baseline in the number of non-inflammatory acne lesions on face measure: At least two-grade improvement in IGA scores measure: Assessment of vaccine-antigen-specific serum antibody titers sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: True Blue Clinical Research Site Number : 8400016 status: RECRUITING city: Brandon state: Florida zip: 33511 country: United States lat: 27.9378 lon: -82.28592 facility: Jacksonville Center for Clinical Research Site Number : 8400006 status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States lat: 30.33218 lon: -81.65565 facility: DelRicht Research Site Number : 8400013 status: RECRUITING city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: Metro Boston Clinical Partners Site Number : 8400008 status: RECRUITING city: Brighton state: Massachusetts zip: 02135 country: United States lat: 42.3501 lon: -71.15644 facility: DermResearch Center of New York, Inc Site Number : 8400010 status: RECRUITING city: Stony Brook state: New York zip: 11790 country: United States lat: 40.92565 lon: -73.14094 facility: Lynn Health Science Institute (LHSI) Site Number : 8400004 status: RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Dermresearch Site Number : 8400009 status: RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Center for Clinical Studies, LTD. LLP Site Number : 8400002 status: RECRUITING city: Houston state: Texas zip: 77004 country: United States lat: 29.76328 lon: -95.36327 hasResults: False