Home › Acne › NCT06316297
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
RecruitingPhase 1/2
A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age
Who can join
Ages 18 to 45 · All sexes
Full 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.
About the study
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.
What is being tested
- Acne mRNA vaccine (biological)
- Placebo (other)
Sponsor: Sanofi Pasteur, a Sanofi Company · Participants: 800 · Started: Apr 5, 2024
Contact the study team
- Trial Transparency email recommended (Toll free for US & Canada) · Phone: 800-633-1610
Official record on ClinicalTrials.gov — NCT06316297
Locations in the U.S.
| Arizona | Center for Dermatology and Plastic Surgery- Site Number : 8400111, Scottsdale |
| California | Private Practice - Dr. Francisco Badar- Site Number : 8400067, Cerritos Encino Research Center- Site Number : 8400033, Encino Paradigm Clinical Research Centers- Site Number : 8400064, La Mesa Sunwise Clinical Research- Site Number : 8400108, Lafayette Chemidox Clinical Trials- Site Number : 8400075, Lancaster Alliance Clinical - West Hills- Site Number : 8400131, Los Angeles Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058, Los Angeles LA Universal Research Center- Site Number : 8400059, Los Angeles Carbon Health - North Hollywood - NoHo West- Site Number : 8400076, North Hollywood Northridge Clinical Trials - Northridge- Site Number : 8400053, Northridge Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099, Oceanside Cura Clinical Research - Oxnard- Site Number : 8400062, Oxnard Amicis Research Center, LLC- Site Number : 8400110, Palmdale Empire Clinical Research - Pomona- Site Number : 8400055, Pomona Peninsula Research Associates- Site Number : 8400102, Rolling Hills Estates Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103, San Diego California Research Foundation- Site Number : 8400095, San Diego NorthBay Clinical Research- Site Number : 8400066, Santa Rosa |
| Florida | Encore Medical Research of Boynton Beach- Site Number : 8400116, Boynton Beach Driven Research- Site Number : 8400135, Coral Gables HealthMed Clinical Center- Site Number : 8400071, Coral Gables Universal Medical Research - Coral Gables- Site Number : 8400081, Coral Gables Genomics Medical Research- Site Number : 8400120, Cutler Bay Direct Helpers Research Center- Site Number : 8400118, Hialeah Encore Medical Research - Hollywood- Site Number : 8400122, Hollywood Zenith Clinical Research- Site Number : 8400127, Hollywood Universal Medical and Research Center- Site Number : 8400079, Homestead Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006, Jacksonville K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063, Lady Lake Advanced Medical Research Institute - Miami- Site Number : 8400100, Miami Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106, Miami Health and Life Research Institute- Site Number : 8400070, Miami SouthCoast Research Center- Site Number : 8400114, Miami WellQuest Clinical- Site Number : 8400082, Miami Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021, Ocala Leading Edge Dermatology- Site Number : 8400077, Plantation Nuline Clinical Trial Center- Site Number : 8400060, Pompano Beach D&H Tamarac Research Center- Site Number : 8400121, Tamarac CenExel FCR Tampa- Site Number : 8400130, Tampa Optimum Clinical Trial Group- Site Number : 8400125, Tampa TrueBlue Clinical Research- Site Number : 8400016, Tampa |
| Georgia | Accel Research Sites - NeuroStudies- Site Number : 8400134, Decatur |
| Illinois | MetroMed Clinical Trials- Site Number : 8400054, Chicago AMR Chicago- Site Number : 8400019, Oak Brook NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031, Skokie |
| Indiana | Dawes Fretzin Clinical Research- Site Number : 8400022, Indianapolis |
| Iowa | Accellacare - McFarland Clinic- Site Number : 8400045, Ames The Iowa Clinic West Des Moines Campus- Site Number : 8400084, West Des Moines |
| Kentucky | Equity Medical - Bowling Green- Site Number : 8400093, Bowling Green |
| Louisiana | Louisiana Dermatology Associates- Site Number : 8400043, Baton Rouge Clinical Trials Management - Metairie- Site Number : 8400072, Metairie DelRicht Research - New Orleans 308- Site Number : 8400013, New Orleans |
| Maryland | Private Practice - Dr. Lawrence J. Green- Site Number : 8400024, Rockville |
| Massachusetts | MetroBoston Clinical Partners - Brighton- Site Number : 8400008, Brighton Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096, Marlborough |
| Michigan | Michigan Institute of Research- Site Number : 8400092, Allen Park Vida Clinical Studies - Dearborn Heights- Site Number : 8400074, Dearborn Heights |
| Minnesota | Clinical Research Institute - Minneapolis- Site Number : 8400080, Minneapolis |
| Missouri | MediSearch Clinical Trials- Site Number : 8400035, Saint Joseph |
| Montana | Boeson Research - Missoula- Site Number : 8400069, Missoula |
| Nevada | Las Vegas Clinical Trials- Site Number : 8400056, Las Vegas |
| North Carolina | Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104, Wilmington |
| Oklahoma | Lynn Institute of Oklahoma City- Site Number : 8400004, Oklahoma City |
| Pennsylvania | Best Skin Research - Camp Hill- Site Number : 8400017, Camp Hill |
| South Carolina | Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047, Mt. Pleasant |
| Tennessee | DelRicht Research - Thompson's Station- Site Number : 8400041, Smyrna |
| Texas | Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115, Baytown DFW Clinical Trials- Site Number : 8400057, Carrollton Modern Research Associates- Site Number : 8400094, Dallas Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002, Houston Lone Star Clinical Research - Katy- Site Number : 8400049, Katy DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046, Prosper |
| Utah | Cope Family Medicine - Ogden Clinic- Site Number : 8400112, Bountiful Alpine Research Association- Site Number : 8400050, Layton CenExel JRB - Salth Lake City- Site Number : 8400128, Salt Lake City Springville Dermatology - Springville- Site Number : 8400113, Springville |
| Virginia | The Education & Research Foundation- Site Number : 8400036, Lynchburg |
| Washington | Seattle Clinical Research Center- Site Number : 8400038, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.