Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
Study of Investigational Vaccine for Mild Acne
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 Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Acne
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Age: 18 years - 45 years
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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 immune response of an investigational vaccine for individuals with mild acne. Acne is a common skin condition characterized by pimples, blackheads, and whiteheads. The study will assess the effects of two doses of the vaccine in adults aged 18 to 45 years.
Participants will be divided into a Sentinel Cohort and a Main Cohort. The Sentinel Cohort will first receive the vaccine to ensure safety before the Main Cohort. Procedures include medical evaluations, laboratory tests, and monitoring for any side effects.
- Who can participate: Eligible participants are healthy adults aged 18 to 45 with mild facial acne vulgaris. They must have 10 to 24 non-inflammatory lesions and 5 to 19 inflammatory lesions, with no nodulocystic lesions. Participants should not have any conditions that could interfere with the study or a history of severe allergic reactions.
- Study details: Participants will receive two administrations of the investigational vaccine. They will undergo medical evaluations and laboratory tests to monitor their health and any reactions to the vaccine.
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