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Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
Sponsor: Sanofi Pasteur, a Sanofi Company
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 three 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 a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2024-04-05
Completion Date
2028-08-31
Last Updated
2025-11-24
Healthy Volunteers
No
Conditions
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
Locations (93)
Center for Dermatology and Plastic Surgery- Site Number : 8400111
Scottsdale, Arizona, United States
Private Practice - Dr. Francisco Badar- Site Number : 8400067
Cerritos, California, United States
Encino Research Center- Site Number : 8400033
Encino, California, United States
Paradigm Clinical Research Centers- Site Number : 8400064
La Mesa, California, United States
Sunwise Clinical Research- Site Number : 8400108
Lafayette, California, United States
Chemidox Clinical Trials- Site Number : 8400075
Lancaster, California, United States
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
Los Angeles, California, United States
LA Universal Research Center- Site Number : 8400059
Los Angeles, California, United States
Alliance Clinical - West Hills- Site Number : 8400131
Los Angeles, California, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
North Hollywood, California, United States
Northridge Clinical Trials - Northridge- Site Number : 8400053
Northridge, California, United States
Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099
Oceanside, California, United States
Cura Clinical Research - Oxnard- Site Number : 8400062
Oxnard, California, United States
Amicis Research Center, LLC- Site Number : 8400110
Palmdale, California, United States
Empire Clinical Research - Pomona- Site Number : 8400055
Pomona, California, United States
Peninsula Research Associates- Site Number : 8400102
Rolling Hills Estates, California, United States
Artemis Institute for Clinical Research, LLC- Site Number : 8400103
San Diego, California, United States
California Research Foundation- Site Number : 8400095
San Diego, California, United States
NorthBay Clinical Research- Site Number : 8400066
Santa Rosa, California, United States
Encore Medical Research of Boynton Beach- Site Number : 8400116
Boynton Beach, Florida, United States
Driven Research- Site Number : 8400135
Coral Gables, Florida, United States
HealthMed Clinical Center Inc.- Site Number : 8400071
Coral Gables, Florida, United States
Universal Medical Research - Coral Gables- Site Number : 8400081
Coral Gables, Florida, United States
Genomics Medical Research- Site Number : 8400120
Cutler Bay, Florida, United States
Direct Helpers Research Center- Site Number : 8400118
Hialeah, Florida, United States
Zenith Clinical Research- Site Number : 8400127
Hollywood, Florida, United States
Encore Medical Research - Hollywood- Site Number : 8400122
Hollywood, Florida, United States
Universal Medical and Research Center- Site Number : 8400079
Homestead, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, United States
K2 Summit Research LLC - Site Number : 8400063
Lady Lake, Florida, United States
Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106
Miami, Florida, United States
SouthCoast Research Center- Site Number : 8400114
Miami, Florida, United States
Advanced Medical Research Institute - Miami- Site Number : 8400100
Miami, Florida, United States
Health and Life Research Institute, LLC- Site Number : 8400070
Miami, Florida, United States
WellQuest Clinical- Site Number : 8400082
Miami, Florida, United States
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021
Ocala, Florida, United States
Leading Edge Dermatology- Site Number : 8400077
Plantation, Florida, United States
Nuline Clinical Trial Center- Site Number : 8400060
Pompano Beach, Florida, United States
D&H Tamarac Research Center- Site Number : 8400121
Tamarac, Florida, United States
TrueBlue Clinical Research- Site Number : 8400016
Tampa, Florida, United States
Optimum Clinical Trial Group- Site Number : 8400125
Tampa, Florida, United States
CenExel FCR Tampa- Site Number : 8400130
Tampa, Florida, United States
Accel Research Sites - NeuroStudies- Site Number : 8400134
Decatur, Georgia, United States
MetroMed Clinical Trials- Site Number : 8400054
Chicago, Illinois, United States
AMR Chicago- Site Number : 8400019
Oak Brook, Illinois, United States
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031
Skokie, Illinois, United States
Dawes Fretzin Clinical Research- Site Number : 8400022
Indianapolis, Indiana, United States
Accellacare - McFarland Clinic- Site Number : 8400045
Ames, Iowa, United States
The Iowa Clinic West Des Moines Campus- Site Number : 8400084
West Des Moines, Iowa, United States
Equity Medical - Bowling Green- Site Number : 8400093
Bowling Green, Kentucky, United States
Louisiana Dermatology Associates- Site Number : 8400043
Baton Rouge, Louisiana, United States
Clinical Trials Management - Metairie- Site Number : 8400072
Metairie, Louisiana, United States
DelRicht Research - New Orleans 308- Site Number : 8400013
New Orleans, Louisiana, United States
Private Practice - Dr. Lawrence J. Green- Site Number : 8400024
Rockville, Maryland, United States
MetroBoston Clinical Partners - Brighton- Site Number : 8400008
Brighton, Massachusetts, United States
Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096
Marlborough, Massachusetts, United States
Michigan Institute of Research- Site Number : 8400092
Allen Park, Michigan, United States
Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
Dearborn Heights, Michigan, United States
Clinical Research Institute - Minneapolis- Site Number : 8400080
Minneapolis, Minnesota, United States
MediSearch Clinical Trials- Site Number : 8400035
Saint Joseph, Missouri, United States
Boeson Research - Missoula- Site Number : 8400069
Missoula, Montana, United States
Las Vegas Clinical Trials- Site Number : 8400056
Las Vegas, Nevada, United States
Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104
Wilmington, North Carolina, United States
Lynn Institute of Oklahoma City- Site Number : 8400004
Oklahoma City, Oklahoma, United States
Best Skin Research - Camp Hill- Site Number : 8400017
Camp Hill, Pennsylvania, United States
Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047
Mt. Pleasant, South Carolina, United States
DelRicht Research - Thompson's Station- Site Number : 8400041
Smyrna, Tennessee, United States
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115
Baytown, Texas, United States
DFW Clinical Trials- Site Number : 8400057
Carrollton, Texas, United States
Modern Research Associates- Site Number : 8400094
Dallas, Texas, United States
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
Houston, Texas, United States
Lone Star Clinical Research - Katy- Site Number : 8400049
Katy, Texas, United States
DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046
Prosper, Texas, United States
Cope Family Medicine - Ogden Clinic- Site Number : 8400112
Bountiful, Utah, United States
Alpine Research Association- Site Number : 8400050
Layton, Utah, United States
CenExel JRB - Salth Lake City- Site Number : 8400128
Salt Lake City, Utah, United States
Springville Dermatology - Springville- Site Number : 8400113
Springville, Utah, United States
The Education & Research Foundation- Site Number : 8400036
Lynchburg, Virginia, United States
Seattle Clinical Research Center- Site Number : 8400038
Seattle, Washington, United States
Investigational Site Number : 0360001
Phillip, Australian Capital Territory, Australia
Investigational Site Number : 0360008
Kotara, New South Wales, Australia
Investigational Site Number : 0360003
Sydney, New South Wales, Australia
Investigational Site Number : 0360006
Waitara, New South Wales, Australia
Investigational Site Number : 0360005
Woolloongabba, Queensland, Australia
Investigational Site Number : 0360007
Carlton, Victoria, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Investigational Site Number : 0360009
Melbourne, Victoria, Australia
Investigational Site Number : 1240006
Edmonton, Alberta, Canada
Investigational Site Number : 1240001
Barrie, Ontario, Canada
Investigational Site Number : 1240004
Toronto, Ontario, Canada
Investigational Site Number : 1240009
Montreal, Quebec, Canada
Investigational Site Number : 1240007
Québec, Quebec, Canada
Investigational Site Number : 1240008
Sherbrooke, Quebec, Canada