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NCT06316297PHASE1, PHASE2Recruiting

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

Sanofi Pasteur, a Sanofi Company

Start Date

4/5/2024

Completion Date

11/30/2028

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 45 years

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.

Interventions

BIOLOGICAL

Acne mRNA vaccine

OTHER

Placebo

Interested in This Trial?

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Conditions

Acne

Locations

Center for Dermatology and Plastic Surgery- Site Number : 8400111

Scottsdale, Arizona 85260

United States

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

Cerritos, California 90703

United States

Encino Research Center- Site Number : 8400033

Encino, California 91436

United States

Paradigm Clinical Research Centers- Site Number : 8400064

La Mesa, California 91942

United States

Sunwise Clinical Research- Site Number : 8400108

Lafayette, California 94549

United States

Chemidox Clinical Trials- Site Number : 8400075

Lancaster, California 93534

United States

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

Los Angeles, California 90027

United States

LA Universal Research Center- Site Number : 8400059

Los Angeles, California 90057

United States

Alliance Clinical - West Hills- Site Number : 8400131

Los Angeles, California 91307

United States

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

North Hollywood, California 91606

United States

Northridge Clinical Trials - Northridge- Site Number : 8400053

Northridge, California 91325

United States

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

Oceanside, California 92056

United States

Cura Clinical Research - Oxnard- Site Number : 8400062

Oxnard, California 93030

United States

Amicis Research Center, LLC- Site Number : 8400110

Palmdale, California 93551

United States

Empire Clinical Research - Pomona- Site Number : 8400055

Pomona, California 91767

United States

Peninsula Research Associates- Site Number : 8400102

Rolling Hills Estates, California 90274

United States

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

San Diego, California 92103

United States

California Research Foundation- Site Number : 8400095

San Diego, California 92123

United States

NorthBay Clinical Research- Site Number : 8400066

Santa Rosa, California 95405

United States

Encore Medical Research of Boynton Beach- Site Number : 8400116

Boynton Beach, Florida 33436

United States

Driven Research- Site Number : 8400135

Coral Gables, Florida 33134

United States

HealthMed Clinical Center- Site Number : 8400071

Coral Gables, Florida 33134

United States

Universal Medical Research - Coral Gables- Site Number : 8400081

Coral Gables, Florida 33134

United States

Genomics Medical Research- Site Number : 8400120

Cutler Bay, Florida 33157

United States

Direct Helpers Research Center- Site Number : 8400118

Hialeah, Florida 33012

United States

Zenith Clinical Research- Site Number : 8400127

Hollywood, Florida 33021

United States

Encore Medical Research - Hollywood- Site Number : 8400122

Hollywood, Florida 33024

United States

Universal Medical and Research Center- Site Number : 8400079

Homestead, Florida 33030

United States

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

Jacksonville, Florida 32216

United States

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

Lady Lake, Florida 32159

United States

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

Miami, Florida 33126

United States

SouthCoast Research Center- Site Number : 8400114

Miami, Florida 33136

United States

Advanced Medical Research Institute - Miami- Site Number : 8400100

Miami, Florida 33174

United States

Health and Life Research Institute- Site Number : 8400070

Miami, Florida 33176

United States

WellQuest Clinical- Site Number : 8400082

Miami, Florida 33176

United States

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

Ocala, Florida 34470

United States

Leading Edge Dermatology- Site Number : 8400077

Plantation, Florida 33317

United States

Nuline Clinical Trial Center- Site Number : 8400060

Pompano Beach, Florida 33060

United States

D&H Tamarac Research Center- Site Number : 8400121

Tamarac, Florida 33321

United States

TrueBlue Clinical Research- Site Number : 8400016

Tampa, Florida 33609

United States

Optimum Clinical Trial Group- Site Number : 8400125

Tampa, Florida 33612

United States

CenExel FCR Tampa- Site Number : 8400130

Tampa, Florida 33613

United States

Accel Research Sites - NeuroStudies- Site Number : 8400134

Decatur, Georgia 30030

United States

MetroMed Clinical Trials- Site Number : 8400054

Chicago, Illinois 60614

United States

AMR Chicago- Site Number : 8400019

Oak Brook, Illinois 60523

United States

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

Skokie, Illinois 60077

United States

Dawes Fretzin Clinical Research- Site Number : 8400022

Indianapolis, Indiana 46256

United States

Accellacare - McFarland Clinic- Site Number : 8400045

Ames, Iowa 50010

United States

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

West Des Moines, Iowa 50266

United States

Equity Medical - Bowling Green- Site Number : 8400093

Bowling Green, Kentucky 42104

United States

Louisiana Dermatology Associates- Site Number : 8400043

Baton Rouge, Louisiana 70809

United States

Clinical Trials Management - Metairie- Site Number : 8400072

Metairie, Louisiana 70006

United States

DelRicht Research - New Orleans 308- Site Number : 8400013

New Orleans, Louisiana 70115

United States

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

Rockville, Maryland 20850

United States

MetroBoston Clinical Partners - Brighton- Site Number : 8400008

Brighton, Massachusetts 02135

United States

Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096

Marlborough, Massachusetts 01752

United States

Michigan Institute of Research- Site Number : 8400092

Allen Park, Michigan 48101

United States

Vida Clinical Studies - Dearborn Heights- Site Number : 8400074

Dearborn Heights, Michigan 48127

United States

Clinical Research Institute - Minneapolis- Site Number : 8400080

Minneapolis, Minnesota 55402

United States

MediSearch Clinical Trials- Site Number : 8400035

Saint Joseph, Missouri 64506

United States

Boeson Research - Missoula- Site Number : 8400069

Missoula, Montana 59804

United States

Las Vegas Clinical Trials- Site Number : 8400056

Las Vegas, Nevada 89030

United States

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

Wilmington, North Carolina 28403

United States

Lynn Institute of Oklahoma City- Site Number : 8400004

Oklahoma City, Oklahoma 73112

United States

Best Skin Research - Camp Hill- Site Number : 8400017

Camp Hill, Pennsylvania 17011

United States

Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047

Mt. Pleasant, South Carolina 29464

United States

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

Smyrna, Tennessee 37167

United States

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

Baytown, Texas 77521

United States

DFW Clinical Trials- Site Number : 8400057

Carrollton, Texas 75010

United States

Modern Research Associates- Site Number : 8400094

Dallas, Texas 75231

United States

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

Houston, Texas 77004

United States

Lone Star Clinical Research - Katy- Site Number : 8400049

Katy, Texas 77450

United States

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

Prosper, Texas 75078

United States

Cope Family Medicine - Ogden Clinic- Site Number : 8400112

Bountiful, Utah 84010

United States

Alpine Research Association- Site Number : 8400050

Layton, Utah 84041

United States

CenExel JRB - Salth Lake City- Site Number : 8400128

Salt Lake City, Utah 84107

United States

Springville Dermatology - Springville- Site Number : 8400113

Springville, Utah 84663

United States

The Education & Research Foundation- Site Number : 8400036

Lynchburg, Virginia 24501

United States

Seattle Clinical Research Center- Site Number : 8400038

Seattle, Washington 98104

United States

Investigational Site Number : 0360001

Phillip, Australian Capital Territory 2606

Australia

Investigational Site Number : 0360008

Kotara, New South Wales 2289

Australia

Investigational Site Number : 0360003

Sydney, New South Wales 2010

Australia

Investigational Site Number : 0360006

Waitara, New South Wales 2077

Australia

Investigational Site Number : 0360005

Woolloongabba, Queensland 4102

Australia

Investigational Site Number : 0360007

Carlton, Victoria 3053

Australia

Investigational Site Number : 0360002

Melbourne, Victoria 3004

Australia

Investigational Site Number : 0360009

Melbourne, Victoria 3124

Australia

Investigational Site Number : 1240006

Edmonton, Alberta T5J 3S9

Canada

Investigational Site Number : 1240001

Barrie, Ontario L4M 7G1

Canada

Investigational Site Number : 1240004

Toronto, Ontario M4E 1R7

Canada

Investigational Site Number : 1240009

Montreal, Quebec H1Y 3L1

Canada

Investigational Site Number : 1240007

Québec, Quebec G1W 4R4

Canada

Investigational Site Number : 1240008

Sherbrooke, Quebec J1G 1X9

Canada

Investigational Site Number : 6300002

San Juan, 00909

Puerto Rico