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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Sanofi Pasteur, a Sanofi Company • ClinicalTrials.gov ID: NCT06316297

Registry updated: 2026-08-21
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Description

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.

Interventions

  • Acne mRNA vaccine (Biological)
    Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular
  • Placebo (Other)
    Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular

Eligibility criteria

Inclusion Criteria: * 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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts) Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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 * Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica) * Use of any acne-affecting treatment without an appropriate washout period * Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration * Previous vaccination against C. acnes with an investigational vaccine * 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. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Conditions

Acne

Locations

  • Center for Dermatology and Plastic Surgery- Site Number : 8400111 — Scottsdale, Arizona, United States
  • Private Practice - Dr. Francisco Badar- Site Number : 8400067 — Cerritos, California, United States
  • Encino Research Center- Site Number : 8400033 — Encino, California, United States
  • Paradigm Clinical Research Centers- Site Number : 8400064 — La Mesa, California, United States
  • Sunwise Clinical Research- Site Number : 8400108 — Lafayette, California, United States
  • Chemidox Clinical Trials- Site Number : 8400075 — Lancaster, California, United States
  • Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058 — Los Angeles, California, United States
  • LA Universal Research Center- Site Number : 8400059 — Los Angeles, California, United States
  • Alliance Clinical - West Hills- Site Number : 8400131 — Los Angeles, California, United States
  • Carbon Health - North Hollywood - NoHo West- Site Number : 8400076 — North Hollywood, California, United States
  • Northridge Clinical Trials - Northridge- Site Number : 8400053 — Northridge, California, United States
  • Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099 — Oceanside, California, United States
  • Cura Clinical Research - Oxnard- Site Number : 8400062 — Oxnard, California, United States
  • Amicis Research Center, LLC- Site Number : 8400110 — Palmdale, California, United States
  • Empire Clinical Research - Pomona- Site Number : 8400055 — Pomona, California, United States
  • Peninsula Research Associates- Site Number : 8400102 — Rolling Hills Estates, California, United States
  • Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103 — San Diego, California, United States
  • California Research Foundation- Site Number : 8400095 — San Diego, California, United States
  • NorthBay Clinical Research- Site Number : 8400066 — Santa Rosa, California, United States
  • Encore Medical Research of Boynton Beach- Site Number : 8400116 — Boynton Beach, Florida, United States
  • Driven Research- Site Number : 8400135 — Coral Gables, Florida, United States
  • HealthMed Clinical Center- Site Number : 8400071 — Coral Gables, Florida, United States
  • Universal Medical Research - Coral Gables- Site Number : 8400081 — Coral Gables, Florida, United States
  • Genomics Medical Research- Site Number : 8400120 — Cutler Bay, Florida, United States
  • Direct Helpers Research Center- Site Number : 8400118 — Hialeah, Florida, United States
  • Zenith Clinical Research- Site Number : 8400127 — Hollywood, Florida, United States
  • Encore Medical Research - Hollywood- Site Number : 8400122 — Hollywood, Florida, United States
  • Universal Medical and Research Center- Site Number : 8400079 — Homestead, Florida, United States
  • Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006 — Jacksonville, Florida, United States
  • K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063 — Lady Lake, Florida, United States
  • Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106 — Miami, Florida, United States
  • SouthCoast Research Center- Site Number : 8400114 — Miami, Florida, United States
  • Advanced Medical Research Institute - Miami- Site Number : 8400100 — Miami, Florida, United States
  • Health and Life Research Institute- Site Number : 8400070 — Miami, Florida, United States
  • WellQuest Clinical- Site Number : 8400082 — Miami, Florida, United States
  • Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021 — Ocala, Florida, United States
  • Leading Edge Dermatology- Site Number : 8400077 — Plantation, Florida, United States
  • Nuline Clinical Trial Center- Site Number : 8400060 — Pompano Beach, Florida, United States
  • D&H Tamarac Research Center- Site Number : 8400121 — Tamarac, Florida, United States
  • TrueBlue Clinical Research- Site Number : 8400016 — Tampa, Florida, United States
  • Optimum Clinical Trial Group- Site Number : 8400125 — Tampa, Florida, United States
  • CenExel FCR Tampa- Site Number : 8400130 — Tampa, Florida, United States
  • Accel Research Sites - NeuroStudies- Site Number : 8400134 — Decatur, Georgia, United States
  • MetroMed Clinical Trials- Site Number : 8400054 — Chicago, Illinois, United States
  • AMR Chicago- Site Number : 8400019 — Oak Brook, Illinois, United States
  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031 — Skokie, Illinois, United States
  • Dawes Fretzin Clinical Research- Site Number : 8400022 — Indianapolis, Indiana, United States
  • Accellacare - McFarland Clinic- Site Number : 8400045 — Ames, Iowa, United States
  • The Iowa Clinic West Des Moines Campus- Site Number : 8400084 — West Des Moines, Iowa, United States
  • Equity Medical - Bowling Green- Site Number : 8400093 — Bowling Green, Kentucky, United States
  • Louisiana Dermatology Associates- Site Number : 8400043 — Baton Rouge, Louisiana, United States
  • Clinical Trials Management - Metairie- Site Number : 8400072 — Metairie, Louisiana, United States
  • DelRicht Research - New Orleans 308- Site Number : 8400013 — New Orleans, Louisiana, United States
  • Private Practice - Dr. Lawrence J. Green- Site Number : 8400024 — Rockville, Maryland, United States
  • MetroBoston Clinical Partners - Brighton- Site Number : 8400008 — Brighton, Massachusetts, United States
  • Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096 — Marlborough, Massachusetts, United States
  • Michigan Institute of Research- Site Number : 8400092 — Allen Park, Michigan, United States
  • Vida Clinical Studies - Dearborn Heights- Site Number : 8400074 — Dearborn Heights, Michigan, United States
  • Clinical Research Institute - Minneapolis- Site Number : 8400080 — Minneapolis, Minnesota, United States
  • MediSearch Clinical Trials- Site Number : 8400035 — Saint Joseph, Missouri, United States
  • Boeson Research - Missoula- Site Number : 8400069 — Missoula, Montana, United States
  • Las Vegas Clinical Trials- Site Number : 8400056 — Las Vegas, Nevada, United States
  • Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104 — Wilmington, North Carolina, United States
  • Lynn Institute of Oklahoma City- Site Number : 8400004 — Oklahoma City, Oklahoma, United States
  • Best Skin Research - Camp Hill- Site Number : 8400017 — Camp Hill, Pennsylvania, United States
  • Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047 — Mt. Pleasant, South Carolina, United States
  • DelRicht Research - Thompson's Station- Site Number : 8400041 — Smyrna, Tennessee, United States
  • Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115 — Baytown, Texas, United States
  • DFW Clinical Trials- Site Number : 8400057 — Carrollton, Texas, United States
  • Modern Research Associates- Site Number : 8400094 — Dallas, Texas, United States
  • Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002 — Houston, Texas, United States
  • Lone Star Clinical Research - Katy- Site Number : 8400049 — Katy, Texas, United States
  • DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046 — Prosper, Texas, United States
  • Cope Family Medicine - Ogden Clinic- Site Number : 8400112 — Bountiful, Utah, United States
  • Alpine Research Association- Site Number : 8400050 — Layton, Utah, United States
  • CenExel JRB - Salth Lake City- Site Number : 8400128 — Salt Lake City, Utah, United States
  • Springville Dermatology - Springville- Site Number : 8400113 — Springville, Utah, United States
  • The Education & Research Foundation- Site Number : 8400036 — Lynchburg, Virginia, United States
  • Seattle Clinical Research Center- Site Number : 8400038 — Seattle, Washington, United States
  • Investigational Site Number : 0360001 — Phillip, Australian Capital Territory, Australia
  • Investigational Site Number : 0360008 — Kotara, New South Wales, Australia
  • Investigational Site Number : 0360003 — Sydney, New South Wales, Australia
  • Investigational Site Number : 0360006 — Waitara, New South Wales, Australia
  • Investigational Site Number : 0360005 — Woolloongabba, Queensland, Australia
  • Investigational Site Number : 0360007 — Carlton, Victoria, Australia
  • Investigational Site Number : 0360002 — Melbourne, Victoria, Australia
  • Investigational Site Number : 0360009 — Melbourne, Victoria, Australia
  • Investigational Site Number : 1240006 — Edmonton, Alberta, Canada
  • Investigational Site Number : 1240001 — Barrie, Ontario, Canada
  • Investigational Site Number : 1240004 — Toronto, Ontario, Canada
  • Investigational Site Number : 1240009 — Montreal, Quebec, Canada
  • Investigational Site Number : 1240007 — Québec, Quebec, Canada
  • Investigational Site Number : 1240008 — Sherbrooke, Quebec, Canada
  • Investigational Site Number : 6300002 — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record