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