Recruiting
Phase 1
Phase 2

Acne mRNA Vaccine

Sponsor:

Sanofi Pasteur, a Sanofi Company

Code:

NCT06316297

Conditions

Acne

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Acne mRNA vaccine

Placebo

Study Details

Brief summary:

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.

Conditions

Acne

Study ID

NCT06316297

Start date

Apr 5, 2024

Status verified date

Aug, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sentinel Cohort A - Experimental

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

placebo comparator: Sentinel Cohort A - Placebo

Two administrations of placebo will be injected

experimental: Sentinel Cohort B - Experimental

Three administrations of the Acne mRNA vaccine will be injected in two increasing doses

placebo comparator: Sentinel Cohort B - Placebo

Three administrations of placebo will be injected

experimental: Main Cohort A - Experimental

Two administrations of the Acne mRNA vaccine will be injected in three increasing doses

placebo comparator: Main Cohort A - Placebo

Two administrations of placebo will be injected

experimental: Main Cohort B - Experimental

Three administrations of the Acne mRNA vaccine will be injected in two increasing doses

placebo comparator: Main Cohort B - Placebo

Three administrations of placebo will be injected

Interventions

Acne mRNA vaccine

Pharmaceutical form: Liquid suspension for injection Route of administration: intramuscular

Placebo

Pharmaceutical form: Liquid solution for injection Route of administration: intramuscular

Primary outcome measure

  • Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs [ Time Frame: 30 minutes after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions [ Time Frame: Up to 7 days after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs [ Time Frame: Up to 28 days after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with SAEs [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with AESIs [ Time Frame: Up to 6 months after each administration ]
  • Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values) [ Time Frame: Through 7 days after administration (Day 8) ]
  • Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face [ Time Frame: At 2 months post last administration ]
  • Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face [ Time Frame: At 2 months post last administration ]
  • Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at [ Time Frame: At 2 months post last administration ]
  • Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs [ Time Frame: Up to 38 or 40 months after first administration ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610contact-us@sanofi.com

Locations

Center for Dermatology and Plastic Surgery- Site Number : 8400111

Recruiting

Scottsdale, Arizona, United States, 85260

Private Practice - Dr. Francisco Badar- Site Number : 8400067

Recruiting

Cerritos, California, United States, 90703

Encino Research Center- Site Number : 8400033

Recruiting

Encino, California, United States, 91436

Paradigm Clinical Research Centers- Site Number : 8400064

Recruiting

La Mesa, California, United States, 91942

Sunwise Clinical Research- Site Number : 8400108

Recruiting

Lafayette, California, United States, 94549

Chemidox Clinical Trials- Site Number : 8400075

Recruiting

Lancaster, California, United States, 93534

Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058

Recruiting

Los Angeles, California, United States, 90027

LA Universal Research Center- Site Number : 8400059

Recruiting

Los Angeles, California, United States, 90057

Alliance Clinical - West Hills- Site Number : 8400131

Recruiting

Los Angeles, California, United States, 91307

Carbon Health - North Hollywood - NoHo West- Site Number : 8400076

Recruiting

North Hollywood, California, United States, 91606

Northridge Clinical Trials - Northridge- Site Number : 8400053

Recruiting

Northridge, California, United States, 91325

Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099

Recruiting

Oceanside, California, United States, 92056

Cura Clinical Research - Oxnard- Site Number : 8400062

Recruiting

Oxnard, California, United States, 93030

Amicis Research Center, LLC- Site Number : 8400110

Recruiting

Palmdale, California, United States, 93551

Empire Clinical Research - Pomona- Site Number : 8400055

Recruiting

Pomona, California, United States, 91767

Peninsula Research Associates- Site Number : 8400102

Recruiting

Rolling Hills Estates, California, United States, 90274

Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103

Recruiting

San Diego, California, United States, 92103

California Research Foundation- Site Number : 8400095

Recruiting

San Diego, California, United States, 92123

NorthBay Clinical Research- Site Number : 8400066

Recruiting

Santa Rosa, California, United States, 95405

Encore Medical Research of Boynton Beach- Site Number : 8400116

Recruiting

Boynton Beach, Florida, United States, 33436

Driven Research- Site Number : 8400135

Recruiting

Coral Gables, Florida, United States, 33134

HealthMed Clinical Center- Site Number : 8400071

Recruiting

Coral Gables, Florida, United States, 33134

Universal Medical Research - Coral Gables- Site Number : 8400081

Recruiting

Coral Gables, Florida, United States, 33134

Genomics Medical Research- Site Number : 8400120

Recruiting

Cutler Bay, Florida, United States, 33157

Direct Helpers Research Center- Site Number : 8400118

Recruiting

Hialeah, Florida, United States, 33012

Zenith Clinical Research- Site Number : 8400127

Recruiting

Hollywood, Florida, United States, 33021

Encore Medical Research - Hollywood- Site Number : 8400122

Recruiting

Hollywood, Florida, United States, 33024

Universal Medical and Research Center- Site Number : 8400079

Recruiting

Homestead, Florida, United States, 33030

Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

Recruiting

Jacksonville, Florida, United States, 32216

K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063

Recruiting

Lady Lake, Florida, United States, 32159

Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106

Recruiting

Miami, Florida, United States, 33126

SouthCoast Research Center- Site Number : 8400114

Recruiting

Miami, Florida, United States, 33136

Advanced Medical Research Institute - Miami- Site Number : 8400100

Recruiting

Miami, Florida, United States, 33174

Health and Life Research Institute- Site Number : 8400070

Recruiting

Miami, Florida, United States, 33176

WellQuest Clinical- Site Number : 8400082

Recruiting

Miami, Florida, United States, 33176

Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021

Recruiting

Ocala, Florida, United States, 34470

Leading Edge Dermatology- Site Number : 8400077

Recruiting

Plantation, Florida, United States, 33317

Nuline Clinical Trial Center- Site Number : 8400060

Recruiting

Pompano Beach, Florida, United States, 33060

D&H Tamarac Research Center- Site Number : 8400121

Recruiting

Tamarac, Florida, United States, 33321

TrueBlue Clinical Research- Site Number : 8400016

Recruiting

Tampa, Florida, United States, 33609

Optimum Clinical Trial Group- Site Number : 8400125

Recruiting

Tampa, Florida, United States, 33612

CenExel FCR Tampa- Site Number : 8400130

Recruiting

Tampa, Florida, United States, 33613

Accel Research Sites - NeuroStudies- Site Number : 8400134

Recruiting

Decatur, Georgia, United States, 30030

MetroMed Clinical Trials- Site Number : 8400054

Recruiting

Chicago, Illinois, United States, 60614

AMR Chicago- Site Number : 8400019

Recruiting

Oak Brook, Illinois, United States, 60523

NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031

Recruiting

Skokie, Illinois, United States, 60077

Dawes Fretzin Clinical Research- Site Number : 8400022

Recruiting

Indianapolis, Indiana, United States, 46256

Accellacare - McFarland Clinic- Site Number : 8400045

Recruiting

Ames, Iowa, United States, 50010

The Iowa Clinic West Des Moines Campus- Site Number : 8400084

Recruiting

West Des Moines, Iowa, United States, 50266

Equity Medical - Bowling Green- Site Number : 8400093

Recruiting

Bowling Green, Kentucky, United States, 42104

Louisiana Dermatology Associates- Site Number : 8400043

Recruiting

Baton Rouge, Louisiana, United States, 70809

Clinical Trials Management - Metairie- Site Number : 8400072

Recruiting

Metairie, Louisiana, United States, 70006

DelRicht Research - New Orleans 308- Site Number : 8400013

Recruiting

New Orleans, Louisiana, United States, 70115

Private Practice - Dr. Lawrence J. Green- Site Number : 8400024

Recruiting

Rockville, Maryland, United States, 20850

MetroBoston Clinical Partners - Brighton- Site Number : 8400008

Recruiting

Brighton, Massachusetts, United States, 02135

Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

Recruiting

Marlborough, Massachusetts, United States, 01752

Michigan Institute of Research- Site Number : 8400092

Recruiting

Allen Park, Michigan, United States, 48101

Vida Clinical Studies - Dearborn Heights- Site Number : 8400074

Recruiting

Dearborn Heights, Michigan, United States, 48127

Clinical Research Institute - Minneapolis- Site Number : 8400080

Recruiting

Minneapolis, Minnesota, United States, 55402

MediSearch Clinical Trials- Site Number : 8400035

Recruiting

Saint Joseph, Missouri, United States, 64506

Boeson Research - Missoula- Site Number : 8400069

Recruiting

Missoula, Montana, United States, 59804

Las Vegas Clinical Trials- Site Number : 8400056

Recruiting

Las Vegas, Nevada, United States, 89030

Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104

Recruiting

Wilmington, North Carolina, United States, 28403

Lynn Institute of Oklahoma City- Site Number : 8400004

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Best Skin Research - Camp Hill- Site Number : 8400017

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

DelRicht Research - Thompson's Station- Site Number : 8400041

Recruiting

Smyrna, Tennessee, United States, 37167

Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115

Recruiting

Baytown, Texas, United States, 77521

DFW Clinical Trials- Site Number : 8400057

Recruiting

Carrollton, Texas, United States, 75010

Modern Research Associates- Site Number : 8400094

Recruiting

Dallas, Texas, United States, 75231

Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002

Recruiting

Houston, Texas, United States, 77004

Lone Star Clinical Research - Katy- Site Number : 8400049

Recruiting

Katy, Texas, United States, 77450

DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046

Recruiting

Prosper, Texas, United States, 75078

Cope Family Medicine - Ogden Clinic- Site Number : 8400112

Recruiting

Bountiful, Utah, United States, 84010

Alpine Research Association- Site Number : 8400050

Recruiting

Layton, Utah, United States, 84041

CenExel JRB - Salth Lake City- Site Number : 8400128

Recruiting

Salt Lake City, Utah, United States, 84107

Springville Dermatology - Springville- Site Number : 8400113

Recruiting

Springville, Utah, United States, 84663

The Education & Research Foundation- Site Number : 8400036

Recruiting

Lynchburg, Virginia, United States, 24501

Seattle Clinical Research Center- Site Number : 8400038

Recruiting

Seattle, Washington, United States, 98104

Investigational Site Number : 1240006

Recruiting

Edmonton, Alberta, Canada, T5J 3S9

Investigational Site Number : 1240001

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Investigational Site Number : 1240004

Recruiting

Toronto, Ontario, Canada, M4E 1R7

Investigational Site Number : 1240009

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

Investigational Site Number : 1240007

Recruiting

Québec, Quebec, Canada, G1W 4R4

Investigational Site Number : 1240008

Recruiting

Sherbrooke, Quebec, Canada, J1G 1X9

More Information

Sponsor

Sanofi Pasteur, a Sanofi Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company on 2026-08-21.