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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 8
- 主要终点
- Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Core Study:
Sentinel Cohort: modified double-blind
- Investigators, participants, laboratory personnel will be blinded
- Clinical site staff preparing/administering the study vaccines will be unblinded
- Sponsor study staff involved in early safety data reviews (ESDRs) will be unblinded at the time of the ESDR Main Cohort: modified double-blind
- Investigators, participants, laboratory personnel and Sponsor study staff will be blinded
- Clinical site staff preparing/administering the study vaccines will be unblinded
- Sponsor staff involved in the Internal Firewall Committee will be unblinded at the time of the interim analysis
Long-term Extension:
Sentinel and Main Cohorts: double-blind
• Investigators, participants, laboratory personnel and Sponsor study staff will be blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 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 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)
排除标准
- •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.
研究组 & 干预措施
Sentinel Cohort Arm 2
Participants will receive 2 Placebo injections
干预措施: Placebo (Other)
Main Cohort Arm 2
Participants will receive 2 Placebo injections
干预措施: Placebo (Other)
Sentinel Cohort Arm 1
Participants will receive 2 Acne mRNA Vaccine injections
干预措施: Acne mRNA vaccine (Biological)
Main Cohort Arm 1
Participants will receive 2 Acne mRNA Vaccine injections
干预措施: Acne mRNA vaccine (Biological)
结局指标
主要结局
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
时间窗: In 30 minutes after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
时间窗: Up to 7 days after each administration
pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
时间窗: Up to 28 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
时间窗: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
时间窗: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
时间窗: Up to 6 months after each administration
Presence of all SAEs
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
时间窗: Through 7 days after administration (Day 08)
Presence of out-of-range biological test results (including shift from baseline values)
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
时间窗: 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
时间窗: 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)
时间窗: Up to 38 months after first administration
Presence of all SAEs and AESIs
次要结局
- Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face(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(At 1 month post first administration to 6 months post last administration)
- Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers(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(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(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 AEs reported(Up to 28 days after each administration)
- Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)(Up to 6 months after each administration)
- Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)(Up to 6 months after each administration)
- Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)(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(Through 7 days after administration (Day 08))
- Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)(In 30 minutes after each administration)
- Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions(Up to 7 days after each administration)