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

Last updated: February 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
U1111-1295-3154
  • 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.

Connect with a study center

  • Encino Research Center Site Number : 8400033

    Encino, California 91436
    United States

    Active - Recruiting

  • True Blue Clinical Research Site Number : 8400016

    Brandon, Florida 33511
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research Site Number : 8400006

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Jacksonville Center for Clinical Research- Site Number : 8400006

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • True Blue Clinical Research- Site Number : 8400016

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research Site Number : 8400019

    Oakbrook Terrace, Illinois 60181
    United States

    Active - Recruiting

  • Accellacare of McFarland Site Number : 8400045

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Louisiana Dermatology Associates LLC, DelRicht Research at LA Dermatology Associates Site Number : 8400043

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • DelRicht Research Site Number : 8400013

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Metro Boston Clinical Partners Site Number : 8400008

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • DermResearch Center of New York, Inc Site Number : 8400010

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Lynn Health Science Institute (LHSI) Site Number : 8400004

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Lynn Health Science Institute (LHSI)- Site Number : 8400004

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Best Skin Research, LLC Site Number : 8400017

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Vial Health @DermDox Dermatology Site Number : 8400017

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Dermresearch Site Number : 8400009

    Austin, Texas 78759
    United States

    Site Not Available

  • Center for Clinical Studies, LTD. LLP Site Number : 8400002

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Center for Clinical Studies, LTD. LLP- Site Number : 8400002

    Houston, Texas 77004
    United States

    Active - Recruiting

  • DelRicht Research at Lockhart Matter Dermatology Site Number : 8400046

    Prosper, Texas 75078
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.