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RecruitingPhase 1/Phase 2

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne

Sanofi Pasteur, a Sanofi Company · NCT07013747

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
228
US sites recruiting
4
Study start
July 3, 2025
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.

Being studied: Acne mRNA vaccine; Placebo

Conditions: Acne

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 mild facial acne vulgaris with:
  • IGA score of mild (grade 2 on the 5-grade IGA scale) AND
  • between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
  • between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
  • no 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
  • Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
  • Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
  • Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
  • 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 patient's potential participation in a clinical trial.

Recruiting US locations

  • Encino Research Center- Site Number : 8400008

    Encino, CA 91436

  • Moore Clinical Research - Brandon- Site Number : 8400007

    Brandon, FL 33511

  • Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006

    Jacksonville, FL 32216

  • DelRicht Research- Site Number : 8400003

    New Orleans, LA 70115

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
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Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA… (NCT07013747) | Bored Studies