[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07013747":3,"trial-entities:NCT07013747":167,"trial-summary:NCT07013747":170},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":76,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":122,"locations":124,"central_contacts":157,"overall_officials":164,"references":165,"see_also_links":166},"NCT07013747","VBE00009","Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne","A Phase 1\u002F2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne","RECRUITING","2030-03-13","2026-07","2026-07-09","2025-07-03","Sanofi Pasteur, a Sanofi Company","INDUSTRY",true,"The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.",null,[19],"Acne",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},228,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BIOLOGICAL","Acne mRNA vaccine","Pharmaceutical form: suspension for injection Route of administration: intramuscular",[35,36],"Main Cohort Arm 1","Sentinel Cohort Arm 1",{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Placebo","Pharmaceutical form: liquid solution for injection Route of administration: intramuscular",[42,43],"Main Cohort Arm 2","Sentinel Cohort Arm 2",[45,48,52,55,58,60,63,67,70,72],{"measure":46,"timeFrame":47},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)","In 30 minutes after each administration",{"measure":49,"description":50,"timeFrame":51},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions","pre-listed in the participant diary \\[PDi\\] and in the case report form \\[CRF\\]","Up to 7 days after each administration",{"measure":53,"timeFrame":54},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported","Up to 28 days after each administration",{"measure":56,"timeFrame":57},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)","Up to 6 months after each administration",{"measure":59,"timeFrame":57},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)",{"measure":61,"description":62,"timeFrame":57},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)","Presence of all SAEs",{"measure":64,"description":65,"timeFrame":66},"Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results","Presence of out-of-range biological test results (including shift from baseline values)","Through 7 days after administration (Day 08)",{"measure":68,"timeFrame":69},"Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face","At 2 months post last administration",{"measure":71,"timeFrame":69},"Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face",{"measure":73,"description":74,"timeFrame":75},"Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)","Presence of all SAEs and AESIs","Up to 38 months after first administration",[77,80,83,84,86,87,89,91,93,95,97,99],{"measure":78,"timeFrame":79},"Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers","From baseline (Day 01) to 6 months post last administration",{"measure":81,"timeFrame":82},"Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face","At 1 month post first administration to 6 months post last administration",{"measure":68,"timeFrame":82},{"measure":85,"timeFrame":82},"Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face",{"measure":71,"timeFrame":82},{"measure":88,"timeFrame":47},"Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)",{"measure":90,"description":50,"timeFrame":51},"Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions",{"measure":92,"timeFrame":54},"Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported",{"measure":94,"timeFrame":57},"Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)",{"measure":96,"timeFrame":57},"Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)",{"measure":98,"description":62,"timeFrame":57},"Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)",{"measure":100,"description":65,"timeFrame":66},"Core Study - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results","ALL","18 Years","45 Years",false,{"inclusion":106,"exclusion":113,"raw_text":121},[107,108,109,110,111,112],"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 mild facial acne vulgaris with:","IGA score of mild (grade 2 on the 5-grade IGA scale) AND","between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND","between 5 to 19 inflammatory lesions (ie, papules and pustules) AND","no nodulocystic lesions (ie, nodules and cysts)",[114,115,116,117,118,119,120],"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; 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","Previous history of or undergoing (suspected or confirmed) myocarditis and\u002For pericarditis and\u002For myopericarditis","Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy","Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection","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","Inclusion Criteria:\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator\n* Clinical diagnosis of mild facial acne vulgaris with:\n\n  * IGA score of mild (grade 2 on the 5-grade IGA scale) AND\n  * between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND\n  * between 5 to 19 inflammatory lesions (ie, papules and pustules) AND\n  * no nodulocystic lesions (ie, nodules and cysts)\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* 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)\n* Known systemic hypersensitivity to any of the study intervention components; 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\n* Previous history of or undergoing (suspected or confirmed) myocarditis and\u002For pericarditis and\u002For myopericarditis\n* Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy\n* Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection\n* Receipt of immune globulins, blood or blood-derived products in the past 3 months\n* Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",[123],"ADULT",[125,134,142,149],{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":130,"geoPoint":131},"Encino Research Center- Site Number : 8400008","Encino","California","91436","United States",{"lat":132,"lon":133},34.15917,-118.50119,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":130,"geoPoint":139},"Moore Clinical Research - Brandon- Site Number : 8400007","Brandon","Florida","33511",{"lat":140,"lon":141},27.9378,-82.28592,{"facility":143,"status":8,"city":144,"state":137,"zip":145,"country":130,"geoPoint":146},"Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006","Jacksonville","32216",{"lat":147,"lon":148},30.33218,-81.65565,{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":130,"geoPoint":154},"DelRicht Research- Site Number : 8400003","New Orleans","Louisiana","70115",{"lat":155,"lon":156},29.95465,-90.07507,[158],{"name":159,"role":160,"phone":161,"phoneExt":162,"email":163},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[],[],[],{"nct_id":4,"conditions":168,"biomarkers":169},[19],[],{"nct_id":4,"found":15,"summary":171,"prompt_version":181},{"design":172,"status":173,"heading":174,"summary":175,"follow_up":176,"word_count":177,"commitments":178,"compensation":179,"drugs_mentioned":180},"This interventional study is evaluating the Acne mRNA vaccine against a placebo. It includes a Core Study with a Sentinel Cohort to assess safety in steps, and a Main Cohort.","completed","Study of Acne mRNA Vaccine for Mild Acne","This study is testing an experimental Acne mRNA vaccine to see how safe and effective it is for people aged 18 to 45 who have mild acne. Researchers will also look at immunogenicity, which means how your body's immune system responds to the vaccine. You would receive either the Acne mRNA vaccine or a placebo (an inactive liquid solution) through an injection into your muscle. The main goal is to track any side effects, both at the injection site and throughout your body, shortly after each vaccine dose and for up to 28 days afterward. To join, you need to be generally healthy and have a clinical diagnosis of mild facial acne, with 10 to 24 non-inflammatory lesions (like blackheads and whiteheads). The study plans to enroll 228 participants.","Participants in the Core Study will be followed for up to 28 days after each administration. If you choose to, you can join an optional Long-Term Extension for an additional 30 months after the Core Study.",129,"Not specified in the trial record.","Not stated in the trial record.",[32,39],"v2"]