A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of an Acne mRNA Vaccine Candidate in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Sanofi
- 入组人数
- 410
- 主要终点
- Unsolicited systemic AEs (Adverse Events)
研究概览
简要总结
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne.
An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population.
Study details are as follows:
- Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements.
- Once the screening period has been completed, the study duration will be up to 13 months for each participant
- Participants will be invited to a long-term extension study through a separate protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12 to 17 years on the day of the first study intervention administration
- •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 study intervention components or history of life-threatening reaction to study intervention(s) or products with the same substances
- •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 wash-out period
- •Any vaccine given in the 4 weeks before or after any injection of study intervention
- •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.
研究组 & 干预措施
Dose 1 sub-cohort - Group 1
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Dose 3 main cohort - Group 9
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Main cohort - Group 10
3 injections
干预措施: Placebo (Biological)
Dose 1 main cohort - Group 7
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Dose 2 main cohort - Group 8
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Dose 1 sub-cohort - Group 2
3 injections
干预措施: Placebo (Biological)
Dose 2 sub-cohort - Group 3
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Dose 2 sub-cohort - Group 4
3 injections
干预措施: Placebo (Biological)
Dose 3 sub-cohort - Group 5
3 injections
干预措施: Acne mRNA (messenger ribonucleic acid) vaccine (Biological)
Dose 3 sub-cohort - Group 6
3 injections
干预措施: Placebo (Biological)
结局指标
主要结局
Unsolicited systemic AEs (Adverse Events)
时间窗: 30 minutes after each injection
Presence of unsolicited systemic adverse events (AEs) reported
Solicited injection site and systemic adverse reactions
时间窗: 8 days, including the day of each injection
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\])
Unsolicited AEs
时间窗: 28 days, including the day of each injection
Presence of unsolicited adverse events (AEs) reported
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
时间窗: Up to 2 months after last injection
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Out-of-range biological test results (including shift from baseline values)
时间窗: Within 8 days after each injection, including the day of injection
次要结局
- Percentage change from baseline in total number of acne lesions on the face(At 2 months after last injection)
- SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation(Up to 13 months)
- Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face(At 1 month after first injection until 9 months after last injection)
- Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face(At 1 month after first injection until 9 months after last injection)
- Absolute and percentage change from baseline in total number of acne lesions on the face(At 1 month after first injection until 9 months after last injection)