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

Sanofi

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acne

Treatments: Biological: Acne mRNA vaccine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07013747

U1111-1315-4645 (Registry Identifier)

2025-520677-39 (Registry Identifier)

VBE00009

Details and patient eligibility

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 Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 (eg, polyethylene glycol [PEG], polysorbate); 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Sentinel Cohort Arm 1

Experimental group

Description:

Participants will receive 2 Acne mRNA Vaccine injections

Treatment:

Biological: Acne mRNA vaccine

Sentinel Cohort Arm 2

Placebo Comparator group

Description:

Participants will receive 2 Placebo injections

Treatment:

Other: Placebo

Main Cohort Arm 1

Experimental group

Description:

Participants will receive 2 Acne mRNA Vaccine injections

Treatment:

Biological: Acne mRNA vaccine

Main Cohort Arm 2

Placebo Comparator group

Description:

Participants will receive 2 Placebo injections

Treatment:

Other: Placebo