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

Официальное название

A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne

Обзор

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.

Вмешательства

• Биопрепарат Acne mRNA vaccine
  Pharmaceutical form: suspension for injection Route of administration: intramuscular
• Другое Placebo
  Pharmaceutical form: liquid solution for injection Route of administration: intramuscular

Первичные конечные точки

• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) [Срок оценки: In 30 minutes after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions [Срок оценки: Up to 7 days after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported [Срок оценки: Up to 28 days after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results [Срок оценки: Through 7 days after administration (Day 08)]
• Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face [Срок оценки: At 2 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face [Срок оценки: At 2 months post last administration]
• Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs) [Срок оценки: Up to 38 months after first administration]

Вторичные конечные точки (12)

• Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers [Срок оценки: From baseline (Day 01) to 6 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face [Срок оценки: At 1 month post first administration to 6 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face [Срок оценки: At 1 month post first administration to 6 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face [Срок оценки: At 1 month post first administration to 6 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face [Срок оценки: At 1 month post first administration to 6 months post last administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) [Срок оценки: In 30 minutes after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions [Срок оценки: Up to 7 days after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported [Срок оценки: Up to 28 days after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs) [Срок оценки: Up to 6 months after each administration]
• Core Study - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results [Срок оценки: Through 7 days after administration (Day 08)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Encino Research Center- Site Number : 8400008 — Encino
• Moore Clinical Research - Brandon- Site Number : 8400007 — Brandon
• Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006 — Jacksonville
• DelRicht Research- Site Number : 8400003 — New Orleans

Идентификаторы

NCT: NCT07013747 · VBE00009 · 2025-520677-39 · U1111-1315-4645

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗