Systems Biological Analysis of Immune Responses to RSV Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Antibody Titers
研究概览
简要总结
The purpose of this study is to characterize the immune response to the FDA-approved mRNA-based RSV vaccine in adults ≥60 years of age, using a systems biology approach. The study aims to generate high-resolution immunologic and systems biology data following vaccination to identify early biomarkers of response and gain mechanistic insight into host immunity.
详细描述
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract disease (LRTD) in older adults and individuals with chronic comorbidities. In response to this burden, several RSV vaccines have recently been licensed for use in adults ≥60 years of age, including products developed by Pfizer, GlaxoSmithKline (GSK), and Moderna. These vaccines represent distinct technological platforms - recombinant protein with adjuvant, bivalent prefusion F (preF) subunit, and messenger RNA (mRNA), respectively - each with demonstrated efficacy in large-scale clinical trials.
Understanding the immunological mechanisms and durability of protection across these platforms remains a major research priority, particularly given the increased use of next-generation vaccine technologies such as mRNA. Systems biology approaches, including transcriptomics, proteomics, metabolomics and advanced immune profiling, provide a powerful means to identify early biomarkers of immunogenicity and long-term antibody persistence. Such approaches have successfully revealed predictive immune signatures in response to a variety of vaccines.
In parallel studies, the researchers have collected samples from individuals who received the Pfizer and GSK RSV vaccines at retail pharmacies under routine clinical use. However, the mRNA-based RSV vaccine (MRESVIA, developed by Moderna) has been less widely deployed to date in community settings, limiting opportunities to collect samples prospectively under real-world conditions. As a result, the researchers are establishing this dedicated protocol to characterize the immune response to MRESVIA using a systems biology approach. Through comprehensive sampling at early and late timepoints post-vaccination, the researchers aim to define molecular and cellular features unique to the mRNA platform and identify early predictors of immune response magnitude and durability. These data will also support future cross-platform comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥60 years of age at the time of enrollment.
- •Able and willing to provide written informed consent.
- •Eligible for receipt of an FDA-approved RSV vaccine (MRESVIA) per Advisory Committee on Immunization Practices (ACIP)/Centers for Disease Control and Prevention (CDC) guidelines.
- •Available for all study visits and procedures, including follow-up through Day
- •Willing to allow access to prior RSV vaccination history (if applicable) for eligibility verification
排除标准
- •History of severe allergic reaction (e.g., anaphylaxis) to any prior vaccines or any component of the MRESVIA vaccine, including polyethylene glycol (PEG), the amino lipid SM-102 (SM-102), or other listed excipients.
- •Acute illness or fever (temperature ≥100.4°F) at the time of vaccination (participant may be rescheduled).
- •Immunocompromising conditions, including:
- •Current cancer chemotherapy or immunosuppressive therapy.
- •History of hematologic malignancies or other immune-mediated diseases that would interfere with vaccine response.
- •Known or suspected HIV infection with cluster of differentiation 4 (CD4) count <200 or uncontrolled viremia.
- •Clinically significant cardiac, pulmonary, renal, hepatic, or neurological disease that, in the opinion of the investigator, would preclude participation or confound interpretation of immune data.
- •Uncontrolled autoimmune disorder.
- •Current use of systemic corticosteroids equivalent to ≥20 mg prednisone daily for more than 14 consecutive days in the past month.
- •History of Guillain-Barré Syndrome or other demyelinating neurological disorders.
- •History of myocarditis, pericarditis, or myopericarditis within the last 2 months.
- •Any bleeding disorder that poses a risk for venipuncture or vaccination complications.
- •Participation in another clinical trial involving an investigational agent within 30 days of enrollment.
- •Receipt or plan receipt of vaccines in the past an upcoming 28 days.
- •Prior receipt of any RSV vaccine.
- •Receipt of blood products or immune globulin within the prior 3 months.
- •History of excessive alcohol consumption or drug use, or psychiatric/social/occupational conditions that may interfere with study compliance.
- •Any other condition that, in the opinion of the investigator, may interfere with study conduct or participant safety.
研究组 & 干预措施
Moderna RSV vaccine (MRESVIA)
Adults who are ≥60 years of age and are eligible to receive FDA-approved RSV vaccines under standard clinical recommendations receive a single dose of the Moderna RSV vaccine (MRESVIA).
干预措施: Moderna RSV vaccine (Biological)
结局指标
主要结局
Antibody Titers
时间窗: Days 28 and 365 post-vaccination
The magnitude of RSV-specific antibody responses following vaccination with an mRNA RSV vaccine (MRESVIA) is assessed as antibody titers at Days 28 and 365 post-vaccination.
Antibody Titers
时间窗: Days 28 and 180 post-vaccination
The magnitude of RSV-specific antibody responses following vaccination with an mRNA RSV vaccine (MRESVIA) is assessed as antibody titers at Days 28 and 180 post-vaccination.
次要结局
- Occurrence of Serious Adverse Events(Up to Day 365 post-vaccination)
- Occurrence of Adverse Events Meeting VAERS Reporting Criteria(Up to Day 365 post-vaccination)
- Frequency of Grade 2 or Higher Adverse Events(Day 28 post-vaccination)
- Severity of Grade 2 or Higher Adverse Events(Day 28 post-vaccination)
- Occurrence of Serious Adverse Events(Up to Day 180 post-vaccination)
- Occurrence of Adverse Events Meeting VAERS Reporting Criteria(Up to Day 180 post-vaccination)