NCT05995275已完成1 期
A Randomised, Placebo-Controlled, Dose-Ranging, Observer-Blind Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of mRNA-1769 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 12
- 主要终点
- Number of Participants with Adverse Events of Special Interest (AESIs)
研究概览
简要总结
The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) between ≥18 kilogram per square meter (kg/m^2) to ≤39 kg/m^
- •For female participants of childbearing potential: must have a negative highly sensitive pregnancy test with 28 days before the first dose of study drug, uses approved contraception during the study intervention period and for at least 3 months after the last dose of study drug, and not currently breastfeeding.
排除标准
- •History of smallpox vaccination, vaccination with any poxvirus-based vaccine, history of of/or recent exposure to Mpox (MPX) (defined as close contact with a confirmed case of MPX within the past 14 days).
- •Participant should not have any significant, progressive, unstable, or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures per Investigator judgement.
- •Participant is undergoing investigations for a potential chronic medical disorder.
- •Bleeding disorder considered a contraindication to IM injection or phlebotomy.
- •Dermatologic conditions that could affect local solicited AR assessments.
- •History of anaphylactic reaction or allergic reactions that required medical intervention following any vaccine.
- •Known or suspected allergy to any component of mRNA-
- •History of malignancy within previous 10 years (excluding non-melanoma skin cancer).
- •Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- •Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrolment. Participants may be rescheduled for enrolment if they no longer meet this criterion within the Screening Period. Inhaled, nasal, and topical steroids are allowed.
- •Receipt or planned receipt of: Any vaccine(s), authorised or approved by local health agency, including mRNA vaccine, ≤28 days prior to the first injection through 28 days after the last dose of investigational (IMP).
- •Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to the first injection up to the end of the study.
- •Participated in an interventional study/received an investigational product within 28 days prior to the Screening Period or plans to do so while enroled in this study.
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
mRNA-1769 Dose A
Experimental
Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
干预措施: mRNA-1769 (Biological)
mRNA-1769 Dose B
Experimental
Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
干预措施: mRNA-1769 (Biological)
mRNA-1769 Dose C
Experimental
Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
干预措施: mRNA-1769 (Biological)
Placebo
Placebo Comparator
Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Day 1 up to Day 395
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
时间窗: Day 1 up to Day 395
Number of Participants with Medically-Attended AEs (MAAEs)
时间窗: Day 1 up to Day 395
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Day 1 up to Day 395
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
时间窗: Up to Day 35
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
时间窗: Up to Day 57
次要结局
- Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)(Days 1 and 43)
- Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV(Days 1 and 43)
- Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV(Days 1, 29, 43, and 57)
- Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus(Days 1, 29, 43, and 57)
- Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay(Days 1, 29, 43, and 57)
- Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)(Days 1 and 43)
- Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus(Days 1 and 43)
- Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay(Days 1, 29, 43, and 57)
研究者
研究点 (12)
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