NCT06067230已完成3 期
A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,153
- 试验地点
- 88
- 主要终点
- Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
研究概览
简要总结
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part A: double-blind Part B: open-label (no masking)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 to <60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- •Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
- •Coronary artery disease and/or congestive heart failure.
- •Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
- •Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day
- •Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- •Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
- •Parts A and B:
- •- Able to comply with study requirements.
排除标准
- •Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day
- •Participation in an RSV trial at any time prior to Day 1 is exclusionary.
- •History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- •Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
- •Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day
- •History of myocarditis, pericarditis, or myopericarditis.
- •Previous treatment with alemtuzumab or rituximab within 2 years prior to Day
- •Previous treatment with plasmapheresis within 30 days prior to Day
- •A history of complications of immunosuppression.
- •A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: mRNA-1345 Dose 2
Experimental
Single injection of mRNA-1345 administered IM on Day 1.
干预措施: mRNA-1345 (Biological)
Part A: mRNA-1345 Dose 1
Experimental
Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1.
干预措施: mRNA-1345 (Biological)
Part B: mRNA-1345 Dose 2
Experimental
Two injections of mRNA-1345 administered IM on Day 1 and Day 57.
干预措施: mRNA-1345 (Biological)
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
时间窗: Day 1 through End of Study (Day 730)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
时间窗: Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
时间窗: Day 85
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B
Number of Participants with Unsolicited Adverse Events (AEs)
时间窗: Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B
Number of Participants With Medically Attended AEs (MAAEs)
时间窗: Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
次要结局
- Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29(Day 29)
- Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs(Up to End of Study (Day 730))
- Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels(Baseline up to Day 730)
- Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29(Day 29)
- Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs(Baseline up to Day 730)
- Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs(Baseline up to Day 730)
- Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers(Up to End of Study (Day 730))
- Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29(Day 29)
- Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29(Day 29)
- Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85(Day 85)
- Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels(Baseline up to Day 730)
- Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part B: GMC of Serum RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part B: GMFR of Serum RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels(Baseline up to End of Study (Day 730))
- Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29(Day 29)
- Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs(Up to End of Study (Day 730))
- Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs(Up to End of Study (Day 730))
- Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels(Baseline up to Day 730)
- Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs(Baseline up to Day 730)
- Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers(Up to End of Study (Day 730))
- Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85(Day 85)
- Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs(Up to End of Study (Day 730))
- Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels(Baseline up to End of Study (Day 730))
研究者
研究点 (88)
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