Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Официальное название

A Phase I/II, Randomized, Placebo-controlled, Multi-arm, Dose-finding Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Adults With Moderate to Severe Acne 18 to 45 Years of Age

Обзор

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up after completing their last planned Core Study visit to assess the long-term effects of the vaccine. Participants from Main Cohort B will be invited to another LTE study managed through a separate protocol.

Подробное описание

Acne vulgaris (acne) is a highly prevalent inflammatory skin disease, especially in adolescents and young adults. Acne is estimated to affect 231 million people worldwide, therefore being one of the most prevalent diseases globally. Acne is also one of the top causes of years lived with disability and nonfatal disease burden. Despite being one of the most prevalent diseases worldwide, the mainstays of acne treatment have remained largely unchanged over the past 30 years. To date there is still no safe and effective treatment that can prevent and cure this disease.

The aim of this first-in-human (FIH), Phase I/II trial is to evaluate the safety, efficacy and immunogenicity of the Acne mRNA vaccine candidate at four different dose levels in adults aged 18 to 45 years with moderate to severe acne. The results of this FIH and proof of concept study will allow selection of the vaccine dose level to be used in Phase III pivotal efficacy trial(s) and to generate preliminary data to further select the vaccine regimen.

Вмешательства

• Биопрепарат Acne mRNA vaccine
  Pharmaceutical form: Liquid 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 Cohorts A and B: Number of participants with unsolicited systemic AEs [Срок оценки: 30 minutes after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions [Срок оценки: Up to 7 days after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs [Срок оценки: Up to 28 days after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with SAEs [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with AESIs [Срок оценки: Up to 6 months after each administration]
• Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values) [Срок оценки: Through 7 days after administration (Day 8)]
• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face [Срок оценки: At 2 months post last administration]
• Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face [Срок оценки: At 2 months post last administration]
• Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at [Срок оценки: At 2 months post last administration]

Вторичные конечные точки (12)

• Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of accine-antigen-specific serum antibody titers [Срок оценки: From baseline (Day 1) to 6 months post last administration]
• Core Study - Main Cohort B: Absolute change from baseline (Day 1) in the total number of inflammatory acne lesions on face [Срок оценки: At 1 month post first administration until 9 months post last administration]
• Core Study - Main Cohorts A and B: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face [Срок оценки: At 1 month post first administration until 6 or 9 months post last administration]
• Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face [Срок оценки: At 1 month post first administration until 6 or 9 months post last administration]
• Core Study - Main Cohorts A and B: Absolute change from baseline in IGA score [Срок оценки: At 1 month post first administration until 6 or 9 months post last administration]
• Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs [Срок оценки: 30 minutes after each administration]
• Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions [Срок оценки: Up to 7 days after each administration]
• Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs [Срок оценки: Up to 28 days after each administration]
• Core Study - Main Cohorts A and B: Number of participants with MAAEs [Срок оценки: Up to 6 or 9 months after each administration]
• Core Study - Main Cohorts A and B: Number of participants with SAEs [Срок оценки: Up to 6 or 9 months after each administration]
• Core Study - Main Cohorts A and B: Number of participants with AESIs [Срок оценки: Up to 6 or 9 months after each administration]
• Core Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values) [Срок оценки: Up to 7 days after each administration]

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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 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
• Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
• Use of any acne-affecting treatment without an appropriate washout period
• Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration
• Previous vaccination against C. acnes with an investigational vaccine
• 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 participant'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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 79 центров

• Center for Dermatology and Plastic Surgery- Site Number : 8400111 — Scottsdale
• Private Practice - Dr. Francisco Badar- Site Number : 8400067 — Cerritos
• Encino Research Center- Site Number : 8400033 — Encino
• Paradigm Clinical Research Centers- Site Number : 8400064 — La Mesa
• Sunwise Clinical Research- Site Number : 8400108 — Lafayette
• Chemidox Clinical Trials- Site Number : 8400075 — Lancaster
• Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058 — Los Angeles
• LA Universal Research Center- Site Number : 8400059 — Los Angeles
• … и ещё 71 центр

Австралия · 8 центров

• Investigational Site Number : 0360001 — Phillip
• … и ещё 7 центров

Канада · 6 центров

Список центров уточняется — проверьте первичный протокол.

Пуэрто-Рико · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06316297 · VBE00001 · U1111-1295-3154 · 2025-521740-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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