Actively Recruiting
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
Led by Sanofi Pasteur, a Sanofi Company · Updated on 2026-05-05
800
Participants Needed
93
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 45 years
- Healthy based on medical evaluation including history, physical exam, and lab tests
- Clinical diagnosis of moderate or severe facial acne with an Investigator's Global Assessment score of 3 or 4
- At least 25 non-inflammatory acne lesions and at least 20 inflammatory lesions on the face
- No more than 2 nodulocystic lesions on the face
You will not qualify if you...
- Known or suspected immune deficiency or recent immunosuppressive therapy within 6 months
- Long-term corticosteroid use for more than 2 consecutive weeks within past 3 months
- Known allergy or severe reaction to study vaccine components or mRNA COVID-19 vaccine
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary or other specified acne forms
- Recent or planned vaccination other than study vaccine within 4 weeks before or after study doses
- Previous vaccination against C. acnes with investigational vaccine
- Receipt of immune globulins, blood, or blood products within past 3 months
- Positive for HIV, hepatitis B, or hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 93 locations
1
Center for Dermatology and Plastic Surgery- Site Number : 8400111
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
Private Practice - Dr. Francisco Badar- Site Number : 8400067
Cerritos, California, United States, 90703
Actively Recruiting
3
Encino Research Center- Site Number : 8400033
Encino, California, United States, 91436
Actively Recruiting
4
Paradigm Clinical Research Centers- Site Number : 8400064
La Mesa, California, United States, 91942
Actively Recruiting
5
Sunwise Clinical Research- Site Number : 8400108
Lafayette, California, United States, 94549
Actively Recruiting
6
Chemidox Clinical Trials- Site Number : 8400075
Lancaster, California, United States, 93534
Actively Recruiting
7
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
Los Angeles, California, United States, 90027
Actively Recruiting
8
LA Universal Research Center- Site Number : 8400059
Los Angeles, California, United States, 90057
Actively Recruiting
9
Alliance Clinical - West Hills- Site Number : 8400131
Los Angeles, California, United States, 91307
Actively Recruiting
10
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
North Hollywood, California, United States, 91606
Actively Recruiting
11
Northridge Clinical Trials - Northridge- Site Number : 8400053
Northridge, California, United States, 91325
Actively Recruiting
12
Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099
Oceanside, California, United States, 92056
Actively Recruiting
13
Cura Clinical Research - Oxnard- Site Number : 8400062
Oxnard, California, United States, 93030
Actively Recruiting
14
Amicis Research Center, LLC- Site Number : 8400110
Palmdale, California, United States, 93551
Actively Recruiting
15
Empire Clinical Research - Pomona- Site Number : 8400055
Pomona, California, United States, 91767
Actively Recruiting
16
Peninsula Research Associates- Site Number : 8400102
Rolling Hills Estates, California, United States, 90274
Actively Recruiting
17
Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103
San Diego, California, United States, 92103
Actively Recruiting
18
California Research Foundation- Site Number : 8400095
San Diego, California, United States, 92123
Actively Recruiting
19
NorthBay Clinical Research- Site Number : 8400066
Santa Rosa, California, United States, 95405
Actively Recruiting
20
Encore Medical Research of Boynton Beach- Site Number : 8400116
Boynton Beach, Florida, United States, 33436
Actively Recruiting
21
Driven Research- Site Number : 8400135
Coral Gables, Florida, United States, 33134
Actively Recruiting
22
HealthMed Clinical Center- Site Number : 8400071
Coral Gables, Florida, United States, 33134
Actively Recruiting
23
Universal Medical Research - Coral Gables- Site Number : 8400081
Coral Gables, Florida, United States, 33134
Actively Recruiting
24
Genomics Medical Research- Site Number : 8400120
Cutler Bay, Florida, United States, 33157
Actively Recruiting
25
Direct Helpers Research Center- Site Number : 8400118
Hialeah, Florida, United States, 33012
Actively Recruiting
26
Zenith Clinical Research- Site Number : 8400127
Hollywood, Florida, United States, 33021
Actively Recruiting
27
Encore Medical Research - Hollywood- Site Number : 8400122
Hollywood, Florida, United States, 33024
Actively Recruiting
28
Universal Medical and Research Center- Site Number : 8400079
Homestead, Florida, United States, 33030
Actively Recruiting
29
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, United States, 32216
Actively Recruiting
30
K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063
Lady Lake, Florida, United States, 32159
Actively Recruiting
31
Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106
Miami, Florida, United States, 33126
Actively Recruiting
32
SouthCoast Research Center- Site Number : 8400114
Miami, Florida, United States, 33136
Actively Recruiting
33
Advanced Medical Research Institute - Miami- Site Number : 8400100
Miami, Florida, United States, 33174
Actively Recruiting
34
Health and Life Research Institute- Site Number : 8400070
Miami, Florida, United States, 33176
Actively Recruiting
35
WellQuest Clinical- Site Number : 8400082
Miami, Florida, United States, 33176
Actively Recruiting
36
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021
Ocala, Florida, United States, 34470
Actively Recruiting
37
Leading Edge Dermatology- Site Number : 8400077
Plantation, Florida, United States, 33317
Actively Recruiting
38
Nuline Clinical Trial Center- Site Number : 8400060
Pompano Beach, Florida, United States, 33060
Actively Recruiting
39
D&H Tamarac Research Center- Site Number : 8400121
Tamarac, Florida, United States, 33321
Actively Recruiting
40
TrueBlue Clinical Research- Site Number : 8400016
Tampa, Florida, United States, 33609
Actively Recruiting
41
Optimum Clinical Trial Group- Site Number : 8400125
Tampa, Florida, United States, 33612
Actively Recruiting
42
CenExel FCR Tampa- Site Number : 8400130
Tampa, Florida, United States, 33613
Actively Recruiting
43
Accel Research Sites - NeuroStudies- Site Number : 8400134
Decatur, Georgia, United States, 30030
Actively Recruiting
44
MetroMed Clinical Trials- Site Number : 8400054
Chicago, Illinois, United States, 60614
Actively Recruiting
45
AMR Chicago- Site Number : 8400019
Oak Brook, Illinois, United States, 60523
Actively Recruiting
46
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031
Skokie, Illinois, United States, 60077
Actively Recruiting
47
Dawes Fretzin Clinical Research- Site Number : 8400022
Indianapolis, Indiana, United States, 46256
Actively Recruiting
48
Accellacare - McFarland Clinic- Site Number : 8400045
Ames, Iowa, United States, 50010
Actively Recruiting
49
The Iowa Clinic West Des Moines Campus- Site Number : 8400084
West Des Moines, Iowa, United States, 50266
Actively Recruiting
50
Equity Medical - Bowling Green- Site Number : 8400093
Bowling Green, Kentucky, United States, 42104
Actively Recruiting
51
Louisiana Dermatology Associates- Site Number : 8400043
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
52
Clinical Trials Management - Metairie- Site Number : 8400072
Metairie, Louisiana, United States, 70006
Actively Recruiting
53
DelRicht Research - New Orleans 308- Site Number : 8400013
New Orleans, Louisiana, United States, 70115
Actively Recruiting
54
Private Practice - Dr. Lawrence J. Green- Site Number : 8400024
Rockville, Maryland, United States, 20850
Actively Recruiting
55
MetroBoston Clinical Partners - Brighton- Site Number : 8400008
Brighton, Massachusetts, United States, 02135
Actively Recruiting
56
Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096
Marlborough, Massachusetts, United States, 01752
Actively Recruiting
57
Michigan Institute of Research- Site Number : 8400092
Allen Park, Michigan, United States, 48101
Actively Recruiting
58
Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
Dearborn Heights, Michigan, United States, 48127
Actively Recruiting
59
Clinical Research Institute - Minneapolis- Site Number : 8400080
Minneapolis, Minnesota, United States, 55402
Actively Recruiting
60
MediSearch Clinical Trials- Site Number : 8400035
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
61
Boeson Research - Missoula- Site Number : 8400069
Missoula, Montana, United States, 59804
Actively Recruiting
62
Las Vegas Clinical Trials- Site Number : 8400056
Las Vegas, Nevada, United States, 89030
Actively Recruiting
63
Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104
Wilmington, North Carolina, United States, 28403
Actively Recruiting
64
Lynn Institute of Oklahoma City- Site Number : 8400004
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
65
Best Skin Research - Camp Hill- Site Number : 8400017
Camp Hill, Pennsylvania, United States, 17011
Actively Recruiting
66
Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
67
DelRicht Research - Thompson's Station- Site Number : 8400041
Smyrna, Tennessee, United States, 37167
Actively Recruiting
68
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115
Baytown, Texas, United States, 77521
Actively Recruiting
69
DFW Clinical Trials- Site Number : 8400057
Carrollton, Texas, United States, 75010
Actively Recruiting
70
Modern Research Associates- Site Number : 8400094
Dallas, Texas, United States, 75231
Actively Recruiting
71
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
Houston, Texas, United States, 77004
Actively Recruiting
72
Lone Star Clinical Research - Katy- Site Number : 8400049
Katy, Texas, United States, 77450
Actively Recruiting
73
DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046
Prosper, Texas, United States, 75078
Actively Recruiting
74
Cope Family Medicine - Ogden Clinic- Site Number : 8400112
Bountiful, Utah, United States, 84010
Actively Recruiting
75
Alpine Research Association- Site Number : 8400050
Layton, Utah, United States, 84041
Actively Recruiting
76
CenExel JRB - Salth Lake City- Site Number : 8400128
Salt Lake City, Utah, United States, 84107
Actively Recruiting
77
Springville Dermatology - Springville- Site Number : 8400113
Springville, Utah, United States, 84663
Actively Recruiting
78
The Education & Research Foundation- Site Number : 8400036
Lynchburg, Virginia, United States, 24501
Actively Recruiting
79
Seattle Clinical Research Center- Site Number : 8400038
Seattle, Washington, United States, 98104
Actively Recruiting
80
Investigational Site Number : 0360001
Phillip, Australian Capital Territory, Australia, 2606
Actively Recruiting
81
Investigational Site Number : 0360008
Kotara, New South Wales, Australia, 2289
Actively Recruiting
82
Investigational Site Number : 0360003
Sydney, New South Wales, Australia, 2010
Actively Recruiting
83
Investigational Site Number : 0360006
Waitara, New South Wales, Australia, 2077
Actively Recruiting
84
Investigational Site Number : 0360005
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
85
Investigational Site Number : 0360007
Carlton, Victoria, Australia, 3053
Actively Recruiting
86
Investigational Site Number : 0360002
Melbourne, Victoria, Australia, 3004
Actively Recruiting
87
Investigational Site Number : 0360009
Melbourne, Victoria, Australia, 3124
Actively Recruiting
88
Investigational Site Number : 1240006
Edmonton, Alberta, Canada, T5J 3S9
Actively Recruiting
89
Investigational Site Number : 1240001
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
90
Investigational Site Number : 1240004
Toronto, Ontario, Canada, M4E 1R7
Actively Recruiting
91
Investigational Site Number : 1240009
Montreal, Quebec, Canada, H1Y 3L1
Actively Recruiting
92
Investigational Site Number : 1240007
Québec, Quebec, Canada, G1W 4R4
Actively Recruiting
93
Investigational Site Number : 1240008
Sherbrooke, Quebec, Canada, J1G 1X9
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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