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

Study on Safety and Effects of an Investigational Messenger RNA (mRNA) Vaccine for Mild Acne

Recruiting
18 years - 45 years
All
Phase 1/2
120 participants needed
4 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acne
  • Age: 18 years - 45 years
  • Gender: All

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

This study investigates the safety and effects of an investigational mRNA vaccine for individuals with mild acne. The study will include two groups, a Sentinel Cohort to initially assess safety, and a Main Cohort for broader evaluation.

Participants will receive two administrations of the investigational vaccine. The study will consist of a Core Study phase and an optional Long-Term Extension phase, where participants may be monitored for an additional 30 months to observe long-term effects. The procedures involve health evaluations and vaccine administrations.

  • Who can participate: Participants aged 18 to 45 years with mild facial acne vulgaris, characterized by specific non-inflammatory and inflammatory lesions, can join. They must be healthy based on medical evaluations and free from certain conditions, such as immunodeficiency or allergies to vaccine components.
  • Study details: Participants will receive two doses of the investigational vaccine. The study includes a Core Study and an optional Long-Term Extension phase for those who consent to further follow-up.
Updated on 05 Sep 2025. Study ID: NCT07013747

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