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

Last updated: August 19, 2026
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Recruiting

Phase

1/2

Condition

Scalp Disorders

Acne

Rash

Treatment

Placebo

Acne mRNA vaccine

Clinical Study ID

NCT06316297
VBE00001
2025-521740-38-00
2025
U1111-1295-3154
2025-521740-38
  • Ages 18-45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, and laboratory tests as judged by theinvestigator

  • Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator'sGlobal 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 nodulocysticlesions (ie, nodules and cysts)

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within 6 months prior to the first study intervention administration; or long-termsystemic corticosteroid therapy (prednisone or equivalent for more than 2consecutive weeks within the past 3 months)

  • Known systemic hypersensitivity to any of the study intervention components; historyof a life-threatening reaction to the study interventions used in the study or to aproduct 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 anystudy intervention administration or planned receipt of any vaccine (other than thestudy 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

Total Participants: 800
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
April 05, 2024
Estimated Completion Date:
November 30, 2028

Study Description

Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no safe and effective treatment that can prevent and cure this disease.

The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at four different dose levels in adults aged 18 to 45 years with moderate to severe acne. The results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.

Connect with a study center

  • Investigational Site Number : 0360001

    Phillip, Australian Capital Territory 2606
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360008

    Kotara, New South Wales 2289
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360003

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360006

    Waitara, New South Wales 2077
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360005

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360007

    Carlton, Victoria 3053
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360002

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360009

    Melbourne, Victoria 3124
    Australia

    Active - Recruiting

  • Investigational Site Number : 1240006

    Edmonton, Alberta T5J 3S9
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240001

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240004

    Toronto, Ontario M4E 1R7
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240009

    Montreal, Quebec H1Y 3L1
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240007

    Québec, Quebec G1W 4R4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240008

    Sherbrooke, Quebec J1G 1X9
    Canada

    Active - Recruiting

  • Investigational Site Number : 6300002

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Center for Dermatology and Plastic Surgery- Site Number : 8400111

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

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

    Cerritos, California 90703
    United States

    Active - Recruiting

  • Encino Research Center- Site Number : 8400033

    Encino, California 91436
    United States

    Active - Recruiting

  • Paradigm Clinical Research Centers- Site Number : 8400064

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Sunwise Clinical Research- Site Number : 8400108

    Lafayette, California 94549
    United States

    Active - Recruiting

  • Chemidox Clinical Trials- Site Number : 8400075

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Alliance Clinical - West Hills- Site Number : 8400131

    Los Angeles, California 91307
    United States

    Active - Recruiting

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

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • LA Universal Research Center- Site Number : 8400059

    Los Angeles, California 90057
    United States

    Active - Recruiting

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

    North Hollywood, California 91606
    United States

    Active - Recruiting

  • Northridge Clinical Trials - Northridge- Site Number : 8400053

    Northridge, California 91325
    United States

    Active - Recruiting

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

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Cura Clinical Research - Oxnard- Site Number : 8400062

    Oxnard, California 93030
    United States

    Active - Recruiting

  • Amicis Research Center, LLC- Site Number : 8400110

    Palmdale, California 93551
    United States

    Active - Recruiting

  • Empire Clinical Research - Pomona- Site Number : 8400055

    Pomona, California 91767
    United States

    Active - Recruiting

  • Peninsula Research Associates- Site Number : 8400102

    Rolling Hills Estates, California 90274
    United States

    Active - Recruiting

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

    San Diego, California 92103
    United States

    Active - Recruiting

  • California Research Foundation- Site Number : 8400095

    San Diego, California 92123
    United States

    Active - Recruiting

  • NorthBay Clinical Research- Site Number : 8400066

    Santa Rosa, California 95405
    United States

    Active - Recruiting

  • Encore Medical Research of Boynton Beach- Site Number : 8400116

    Boynton Beach, Florida 33436
    United States

    Active - Recruiting

  • Driven Research- Site Number : 8400135

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • HealthMed Clinical Center- Site Number : 8400071

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Universal Medical Research - Coral Gables- Site Number : 8400081

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Genomics Medical Research- Site Number : 8400120

    Cutler Bay, Florida 33157
    United States

    Active - Recruiting

  • Direct Helpers Research Center- Site Number : 8400118

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Encore Medical Research - Hollywood- Site Number : 8400122

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Zenith Clinical Research- Site Number : 8400127

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Universal Medical and Research Center- Site Number : 8400079

    Homestead, Florida 33030
    United States

    Active - Recruiting

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

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

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

    Lady Lake, Florida 32159
    United States

    Active - Recruiting

  • Advanced Medical Research Institute - Miami- Site Number : 8400100

    Miami, Florida 33174
    United States

    Active - Recruiting

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

    Miami, Florida 33126
    United States

    Active - Recruiting

  • Health and Life Research Institute- Site Number : 8400070

    Miami, Florida 33176
    United States

    Active - Recruiting

  • SouthCoast Research Center- Site Number : 8400114

    Miami, Florida 33136
    United States

    Active - Recruiting

  • WellQuest Clinical- Site Number : 8400082

    Miami, Florida 33176
    United States

    Active - Recruiting

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

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Leading Edge Dermatology- Site Number : 8400077

    Plantation, Florida 33317
    United States

    Active - Recruiting

  • Nuline Clinical Trial Center- Site Number : 8400060

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • D&H Tamarac Research Center- Site Number : 8400121

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • CenExel FCR Tampa- Site Number : 8400130

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Optimum Clinical Trial Group- Site Number : 8400125

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • TrueBlue Clinical Research- Site Number : 8400016

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Accel Research Sites - NeuroStudies- Site Number : 8400134

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • MetroMed Clinical Trials- Site Number : 8400054

    Chicago, Illinois 60614
    United States

    Active - Recruiting

  • AMR Chicago- Site Number : 8400019

    Oak Brook, Illinois 60523
    United States

    Active - Recruiting

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

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research- Site Number : 8400022

    Indianapolis, Indiana 46256
    United States

    Active - Recruiting

  • Accellacare - McFarland Clinic- Site Number : 8400045

    Ames, Iowa 50010
    United States

    Active - Recruiting

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

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green- Site Number : 8400093

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Louisiana Dermatology Associates- Site Number : 8400043

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Clinical Trials Management - Metairie- Site Number : 8400072

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • DelRicht Research - New Orleans 308- Site Number : 8400013

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

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

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • MetroBoston Clinical Partners - Brighton- Site Number : 8400008

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

    Marlborough, Massachusetts 01752
    United States

    Active - Recruiting

  • Michigan Institute of Research- Site Number : 8400092

    Allen Park, Michigan 48101
    United States

    Active - Recruiting

  • Vida Clinical Studies - Dearborn Heights- Site Number : 8400074

    Dearborn Heights, Michigan 48127
    United States

    Active - Recruiting

  • Clinical Research Institute - Minneapolis- Site Number : 8400080

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • MediSearch Clinical Trials- Site Number : 8400035

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Boeson Research - Missoula- Site Number : 8400069

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Las Vegas Clinical Trials- Site Number : 8400056

    Las Vegas, Nevada 89030
    United States

    Active - Recruiting

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

    Wilmington, North Carolina 28403
    United States

    Active - Recruiting

  • Lynn Institute of Oklahoma City- Site Number : 8400004

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Best Skin Research - Camp Hill- Site Number : 8400017

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047

    Mt. Pleasant, South Carolina 29464
    United States

    Active - Recruiting

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

    Smyrna, Tennessee 37167
    United States

    Active - Recruiting

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

    Baytown, Texas 77521
    United States

    Active - Recruiting

  • DFW Clinical Trials- Site Number : 8400057

    Carrollton, Texas 75010
    United States

    Active - Recruiting

  • Modern Research Associates- Site Number : 8400094

    Dallas, Texas 75231
    United States

    Active - Recruiting

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

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Lone Star Clinical Research - Katy- Site Number : 8400049

    Katy, Texas 77450
    United States

    Active - Recruiting

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

    Prosper, Texas 75078
    United States

    Active - Recruiting

  • Cope Family Medicine - Ogden Clinic- Site Number : 8400112

    Bountiful, Utah 84010
    United States

    Active - Recruiting

  • Alpine Research Association- Site Number : 8400050

    Layton, Utah 84041
    United States

    Active - Recruiting

  • CenExel JRB - Salth Lake City- Site Number : 8400128

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Springville Dermatology - Springville- Site Number : 8400113

    Springville, Utah 84663
    United States

    Active - Recruiting

  • The Education & Research Foundation- Site Number : 8400036

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Seattle Clinical Research Center- Site Number : 8400038

    Seattle, Washington 98104
    United States

    Active - Recruiting

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