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

RecruitingPhase 1/2

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

Who can join

Ages 18 to 45 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Sanofi Pasteur, a Sanofi Company · Participants: 800 · Started: Apr 5, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06316297

Locations in the U.S.

ArizonaCenter for Dermatology and Plastic Surgery- Site Number : 8400111, Scottsdale
CaliforniaPrivate Practice - Dr. Francisco Badar- Site Number : 8400067, Cerritos
Encino Research Center- Site Number : 8400033, Encino
Paradigm Clinical Research Centers- Site Number : 8400064, La Mesa
Sunwise Clinical Research- Site Number : 8400108, Lafayette
Chemidox Clinical Trials- Site Number : 8400075, Lancaster
Alliance Clinical - West Hills- Site Number : 8400131, Los Angeles
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058, Los Angeles
LA Universal Research Center- Site Number : 8400059, Los Angeles
Carbon Health - North Hollywood - NoHo West- Site Number : 8400076, North Hollywood
Northridge Clinical Trials - Northridge- Site Number : 8400053, Northridge
Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099, Oceanside
Cura Clinical Research - Oxnard- Site Number : 8400062, Oxnard
Amicis Research Center, LLC- Site Number : 8400110, Palmdale
Empire Clinical Research - Pomona- Site Number : 8400055, Pomona
Peninsula Research Associates- Site Number : 8400102, Rolling Hills Estates
Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103, San Diego
California Research Foundation- Site Number : 8400095, San Diego
NorthBay Clinical Research- Site Number : 8400066, Santa Rosa
FloridaEncore Medical Research of Boynton Beach- Site Number : 8400116, Boynton Beach
Driven Research- Site Number : 8400135, Coral Gables
HealthMed Clinical Center- Site Number : 8400071, Coral Gables
Universal Medical Research - Coral Gables- Site Number : 8400081, Coral Gables
Genomics Medical Research- Site Number : 8400120, Cutler Bay
Direct Helpers Research Center- Site Number : 8400118, Hialeah
Encore Medical Research - Hollywood- Site Number : 8400122, Hollywood
Zenith Clinical Research- Site Number : 8400127, Hollywood
Universal Medical and Research Center- Site Number : 8400079, Homestead
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006, Jacksonville
K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063, Lady Lake
Advanced Medical Research Institute - Miami- Site Number : 8400100, Miami
Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106, Miami
Health and Life Research Institute- Site Number : 8400070, Miami
SouthCoast Research Center- Site Number : 8400114, Miami
WellQuest Clinical- Site Number : 8400082, Miami
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021, Ocala
Leading Edge Dermatology- Site Number : 8400077, Plantation
Nuline Clinical Trial Center- Site Number : 8400060, Pompano Beach
D&H Tamarac Research Center- Site Number : 8400121, Tamarac
CenExel FCR Tampa- Site Number : 8400130, Tampa
Optimum Clinical Trial Group- Site Number : 8400125, Tampa
TrueBlue Clinical Research- Site Number : 8400016, Tampa
GeorgiaAccel Research Sites - NeuroStudies- Site Number : 8400134, Decatur
IllinoisMetroMed Clinical Trials- Site Number : 8400054, Chicago
AMR Chicago- Site Number : 8400019, Oak Brook
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031, Skokie
IndianaDawes Fretzin Clinical Research- Site Number : 8400022, Indianapolis
IowaAccellacare - McFarland Clinic- Site Number : 8400045, Ames
The Iowa Clinic West Des Moines Campus- Site Number : 8400084, West Des Moines
KentuckyEquity Medical - Bowling Green- Site Number : 8400093, Bowling Green
LouisianaLouisiana Dermatology Associates- Site Number : 8400043, Baton Rouge
Clinical Trials Management - Metairie- Site Number : 8400072, Metairie
DelRicht Research - New Orleans 308- Site Number : 8400013, New Orleans
MarylandPrivate Practice - Dr. Lawrence J. Green- Site Number : 8400024, Rockville
MassachusettsMetroBoston Clinical Partners - Brighton- Site Number : 8400008, Brighton
Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096, Marlborough
MichiganMichigan Institute of Research- Site Number : 8400092, Allen Park
Vida Clinical Studies - Dearborn Heights- Site Number : 8400074, Dearborn Heights
MinnesotaClinical Research Institute - Minneapolis- Site Number : 8400080, Minneapolis
MissouriMediSearch Clinical Trials- Site Number : 8400035, Saint Joseph
MontanaBoeson Research - Missoula- Site Number : 8400069, Missoula
NevadaLas Vegas Clinical Trials- Site Number : 8400056, Las Vegas
North CarolinaTrial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104, Wilmington
OklahomaLynn Institute of Oklahoma City- Site Number : 8400004, Oklahoma City
PennsylvaniaBest Skin Research - Camp Hill- Site Number : 8400017, Camp Hill
South CarolinaDelricht Research - Mt Pleasant Dermatology- Site Number : 8400047, Mt. Pleasant
TennesseeDelRicht Research - Thompson's Station- Site Number : 8400041, Smyrna
TexasInquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115, Baytown
DFW Clinical Trials- Site Number : 8400057, Carrollton
Modern Research Associates- Site Number : 8400094, Dallas
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002, Houston
Lone Star Clinical Research - Katy- Site Number : 8400049, Katy
DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046, Prosper
UtahCope Family Medicine - Ogden Clinic- Site Number : 8400112, Bountiful
Alpine Research Association- Site Number : 8400050, Layton
CenExel JRB - Salth Lake City- Site Number : 8400128, Salt Lake City
Springville Dermatology - Springville- Site Number : 8400113, Springville
VirginiaThe Education & Research Foundation- Site Number : 8400036, Lynchburg
WashingtonSeattle Clinical Research Center- Site Number : 8400038, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.