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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acne

In brief

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.

Key facts

Study ID

NCT06316297

Run by

Sanofi Pasteur, a Sanofi Company

People needed

800

Starts

2024-04-05

Expected to finish

2028-11-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Private Practice - Dr. Francisco Badar- Site Number : 8400067 — Cerritos, California, United States (enrolling)
• Encino Research Center- Site Number : 8400033 — Encino, California, United States (enrolling)
• Paradigm Clinical Research Centers- Site Number : 8400064 — La Mesa, California, United States (enrolling)
• Sunwise Clinical Research- Site Number : 8400108 — Lafayette, California, United States (enrolling)
• Chemidox Clinical Trials- Site Number : 8400075 — Lancaster, California, United States (enrolling)
• Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058 — Los Angeles, California, United States (enrolling)
• LA Universal Research Center- Site Number : 8400059 — Los Angeles, California, United States (enrolling)
• Alliance Clinical - West Hills- Site Number : 8400131 — Los Angeles, California, United States (enrolling)
• Carbon Health - North Hollywood - NoHo West- Site Number : 8400076 — North Hollywood, California, United States (enrolling)
• Northridge Clinical Trials - Northridge- Site Number : 8400053 — Northridge, California, United States (enrolling)
• Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099 — Oceanside, California, United States (enrolling)
• Cura Clinical Research - Oxnard- Site Number : 8400062 — Oxnard, California, United States (enrolling)
• Amicis Research Center, LLC- Site Number : 8400110 — Palmdale, California, United States (enrolling)
• Empire Clinical Research - Pomona- Site Number : 8400055 — Pomona, California, United States (enrolling)
• Peninsula Research Associates- Site Number : 8400102 — Rolling Hills Estates, California, United States (enrolling)
• Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103 — San Diego, California, United States (enrolling)
• California Research Foundation- Site Number : 8400095 — San Diego, California, United States (enrolling)
• NorthBay Clinical Research- Site Number : 8400066 — Santa Rosa, California, United States (enrolling)
• Encore Medical Research of Boynton Beach- Site Number : 8400116 — Boynton Beach, Florida, United States (enrolling)
• Driven Research- Site Number : 8400135 — Coral Gables, Florida, United States (enrolling)
• HealthMed Clinical Center- Site Number : 8400071 — Coral Gables, Florida, United States (enrolling)
• Universal Medical Research - Coral Gables- Site Number : 8400081 — Coral Gables, Florida, United States (enrolling)
• Genomics Medical Research- Site Number : 8400120 — Cutler Bay, Florida, United States (enrolling)
• Direct Helpers Research Center- Site Number : 8400118 — Hialeah, Florida, United States (enrolling)
• Center for Dermatology and Plastic Surgery- Site Number : 8400111 — Scottsdale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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