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

Last updated: May 14, 2025
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Recruiting

Phase

1/2

Condition

Rash

Scalp Disorders

Acne

Treatment

Placebo

Acne mRNA vaccine

Clinical Study ID

NCT06316297
VBE00001
2025-521740-38-00
U1111-1295-3154
2025-521740-38
  • Ages 18-45
  • All Genders

Study Summary

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 three dose levels in adult participants aged 18 to 45 years with moderate to severe acne.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical evaluation includingmedical history, physical examination, and laboratory tests as judged by theinvestigator

  • Clinical diagnosis of moderate or severe facial acne vulgaris with Investigator'sGlobal 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 nodulocysticlesions (ie, nodules and cysts)

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,within 6 months prior to the first study intervention administration; or long-termsystemic corticosteroid therapy (prednisone or equivalent for more than 2consecutive weeks within the past 3 months)

  • Known systemic hypersensitivity to any of the study intervention components (eg,polyethylene glycol [PEG], polysorbate); history of a life-threatening reaction tothe study interventions used in the study or to a product containing any of the samesubstances; any allergic reaction (eg, anaphylaxis) after administration of mRNAcoronavirus 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 anystudy intervention administration or planned receipt of any vaccine (other than thestudy 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.

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
April 05, 2024
Estimated Completion Date:
August 31, 2028

Study Description

Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no safe and effective treatment that can prevent and cure this disease.

The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at three different dose levels in adults aged 18 to 45 years with moderate to severe acne. The results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.

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