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 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.

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