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Evaluating an mRNA vaccine for treating moderate to severe acne

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

Phase1; Phase2 Interventional Sanofi · NCT06316297

This study is testing a new mRNA vaccine to see if it can safely help adults aged 18 to 45 with moderate to severe acne.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years to 45 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionschemotherapy, radiation, prednisone
Locations93 sites (Scottsdale, Arizona and 92 other locations)
Trial IDNCT06316297 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 45 with a clinical diagnosis of moderate to severe acne.

Not a fit: Patients with known immunodeficiencies or those on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could offer a novel and effective treatment for individuals suffering from moderate to severe acne.

How similar studies have performed: While the use of mRNA technology is relatively novel in the context of acne treatment, similar approaches in other diseases have shown promising results.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Scottsdale, Arizona and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acne
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.