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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 25
- 主要终点
- Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
研究概览
简要总结
Core Study – Sentinel Cohorts A and B • To assess the safety profile of the Acne mRNA vaccine Core Study – Main Cohorts A and B • To evaluate the efficacy of the Acne mRNA vaccine Long-Term Extension – Sentinel Cohorts A, B and Main Cohort A • To assess the long-term safety profile of the Acne mRNA vaccine
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Diluent : 0,9% sodium chloride solution
干预措施: Diluent : 0,9% sodium chloride solution (Drug)
Acne mRNA vaccine
干预措施: Acne mRNA vaccine (Drug)
结局指标
主要结局
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Core Study - Sentinel Cohorts A and B: Number of patients with SAEs
Core Study - Sentinel Cohorts A and B: Number of patients with SAEs
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Core Study – Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Core Study – Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Long-Term Extension – Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Long-Term Extension – Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
次要结局
- Core Study - Main Cohorts A and B: Number of participants with MAAEs
- Core Study - Main Cohorts A and B: Number of participants with SAEs
- Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of vaccine-antigen-specific serum antibody titers
- Core Study - Main Cohort A and B: Absolute and percentage change from baseline (Day 1) in the total number of acne lesions on face
- Core Study - Main Cohorts A and B: Absolute and percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
- Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
- Core Study - Main Cohorts: Absolute change from baseline in IGA score
- Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs
- Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions
- Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs
- Core Study - Main Cohorts A and B: Number of participants with AESIs
- Cores Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
研究者
Clinical Sciences and Operations
Scientific
Sanofi Pasteur Inc.