Evaluating an mRNA vaccine for treating moderate to severe acne

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to assess the safety, efficacy, and immunogenicity of an mRNA vaccine designed for adults aged 18 to 45 with moderate to severe acne. Participants will receive up to three intramuscular injections of the vaccine at varying dose levels. The study is structured as a first-in-human trial, which will help determine the optimal dose for future Phase III trials. The goal is to provide a new treatment option for a condition that has seen little innovation in recent decades.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center for Dermatology and Plastic Surgery- Site Number : 8400111
  Scottsdale, Arizona, United States Recruiting
• Private Practice - Dr. Francisco Badar- Site Number : 8400067
  Cerritos, California, United States Recruiting
• Encino Research Center- Site Number : 8400033
  Encino, California, United States Recruiting
• Paradigm Clinical Research Centers- Site Number : 8400064
  La Mesa, California, United States Recruiting
• Sunwise Clinical Research- Site Number : 8400108
  Lafayette, California, United States Recruiting
• Chemidox Clinical Trials- Site Number : 8400075
  Lancaster, California, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adapalene/Clindamycin Gel in Vietnamese Acne Patients

  This study tests how safe and tolerable and how well Klenzit-C works when used in routine care by Vietnamese patients aged 12 and up with mild to moderate acne.

  Recruiting at 2 sites Phase 4 Ir Innovate Research Private Limited · Hanoi and 2 other locations · NCT07918001

• Skincare regimen for mild to moderate acne in people with sensitive skin

  A 4-week test will check if a skincare regimen helps with mild to moderate acne in adults with sensitive skin.

  Recruiting USMARI Research & Innovation Centre · Petaling Jaya, Selangor · NCT07749469

• Engineered Lactobacillus reuteri cream with zinc sulfate–tannic acid MPN coating for acne

  This trial will test whether a topical cream containing engineered Lactobacillus reuteri with a zinc sulfate–tannic acid coating can reduce inflammatory acne in adults aged 18–33.

  Recruiting Phase 2 Shenzhen People's Hospital · Shenzhen, Guangdong · NCT07366229

• Probiotic drink for skin inflammation during the menopausal transition

  This study will test whether a daily Lactobacillus casei Shirota probiotic drink can reduce inflammation and improve immune and skin health in women aged 40–60 going through the menopausal transition with inflammatory facial skin conditions.

  Recruiting King's College London · London, London · NCT07341087

• Acne mRNA vaccine for adults with mild facial acne

  This trial will test two injections of an acne mRNA vaccine versus placebo in adults 18–45 with mild facial acne to see if it's safe, triggers an immune response, and improves acne.

  Recruiting at 4 sites Phase 1/2 Sanofi · Encino, California and 3 other locations · NCT07013747

• Evaluating the safety and effects of TVB-3567 in healthy individuals and those with acne

  This study is testing a new drug called TVB-3567 to see how safe it is and how it works in healthy people and those with acne.

  Recruiting at 3 sites Phase 1 Sagimet Biosciences Inc. · Tempe, Arizona and 5 other locations · NCT06989840

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.