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RecruitingPhase 1/Phase 2

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

Sanofi Pasteur, a Sanofi Company · NCT06316297

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
800
US sites recruiting
79
Study start
April 5, 2024
Record last updated
August 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Acne mRNA vaccine; Placebo

Conditions: Acne

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

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

    Scottsdale, AZ 85260

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

    Cerritos, CA 90703

  • Encino Research Center- Site Number : 8400033

    Encino, CA 91436

  • Paradigm Clinical Research Centers- Site Number : 8400064

    La Mesa, CA 91942

  • Sunwise Clinical Research- Site Number : 8400108

    Lafayette, CA 94549

  • Chemidox Clinical Trials- Site Number : 8400075

    Lancaster, CA 93534

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

    Los Angeles, CA 90027

  • LA Universal Research Center- Site Number : 8400059

    Los Angeles, CA 90057

  • Alliance Clinical - West Hills- Site Number : 8400131

    Los Angeles, CA 91307

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

    North Hollywood, CA 91606

  • Northridge Clinical Trials - Northridge- Site Number : 8400053

    Northridge, CA 91325

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

    Oceanside, CA 92056

  • Cura Clinical Research - Oxnard- Site Number : 8400062

    Oxnard, CA 93030

  • Amicis Research Center, LLC- Site Number : 8400110

    Palmdale, CA 93551

  • Empire Clinical Research - Pomona- Site Number : 8400055

    Pomona, CA 91767

  • Peninsula Research Associates- Site Number : 8400102

    Rolling Hills Estates, CA 90274

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

    San Diego, CA 92103

  • California Research Foundation- Site Number : 8400095

    San Diego, CA 92123

  • NorthBay Clinical Research- Site Number : 8400066

    Santa Rosa, CA 95405

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

    Boynton Beach, FL 33436

  • Driven Research- Site Number : 8400135

    Coral Gables, FL 33134

  • HealthMed Clinical Center- Site Number : 8400071

    Coral Gables, FL 33134

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

    Coral Gables, FL 33134

  • Genomics Medical Research- Site Number : 8400120

    Cutler Bay, FL 33157

  • Direct Helpers Research Center- Site Number : 8400118

    Hialeah, FL 33012

  • Zenith Clinical Research- Site Number : 8400127

    Hollywood, FL 33021

  • Encore Medical Research - Hollywood- Site Number : 8400122

    Hollywood, FL 33024

  • Universal Medical and Research Center- Site Number : 8400079

    Homestead, FL 33030

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

    Jacksonville, FL 32216

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

    Lady Lake, FL 32159

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

    Miami, FL 33126

  • SouthCoast Research Center- Site Number : 8400114

    Miami, FL 33136

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

    Miami, FL 33174

  • Health and Life Research Institute- Site Number : 8400070

    Miami, FL 33176

  • WellQuest Clinical- Site Number : 8400082

    Miami, FL 33176

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

    Ocala, FL 34470

  • Leading Edge Dermatology- Site Number : 8400077

    Plantation, FL 33317

  • Nuline Clinical Trial Center- Site Number : 8400060

    Pompano Beach, FL 33060

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

    Tamarac, FL 33321

  • TrueBlue Clinical Research- Site Number : 8400016

    Tampa, FL 33609

  • Optimum Clinical Trial Group- Site Number : 8400125

    Tampa, FL 33612

  • CenExel FCR Tampa- Site Number : 8400130

    Tampa, FL 33613

  • Accel Research Sites - NeuroStudies- Site Number : 8400134

    Decatur, GA 30030

  • MetroMed Clinical Trials- Site Number : 8400054

    Chicago, IL 60614

  • AMR Chicago- Site Number : 8400019

    Oak Brook, IL 60523

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

    Skokie, IL 60077

  • Dawes Fretzin Clinical Research- Site Number : 8400022

    Indianapolis, IN 46256

  • Accellacare - McFarland Clinic- Site Number : 8400045

    Ames, IA 50010

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

    West Des Moines, IA 50266

  • Equity Medical - Bowling Green- Site Number : 8400093

    Bowling Green, KY 42104

  • Louisiana Dermatology Associates- Site Number : 8400043

    Baton Rouge, LA 70809

  • Clinical Trials Management - Metairie- Site Number : 8400072

    Metairie, LA 70006

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

    New Orleans, LA 70115

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

    Rockville, MD 20850

  • MetroBoston Clinical Partners - Brighton- Site Number : 8400008

    Brighton, MA 02135

  • Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

    Marlborough, MA 01752

  • Michigan Institute of Research- Site Number : 8400092

    Allen Park, MI 48101

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

    Dearborn Heights, MI 48127

  • Clinical Research Institute - Minneapolis- Site Number : 8400080

    Minneapolis, MN 55402

  • MediSearch Clinical Trials- Site Number : 8400035

    Saint Joseph, MO 64506

+ 19 more on the official record.

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
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Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA… (NCT06316297) | Bored Studies