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Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.

2022年5月25日 更新者：Novavax

A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.

This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1330

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Redding、California、美国、96001
        • Nothern California Clinical Research
    • Georgia
      • Stockbridge、Georgia、美国、30281
        • Clinical Research Atlanta
    • Kansas
      • Lenexa、Kansas、美国、66219
        • Johnson County Clin-Trials
    • Ohio
      • Cleveland、Ohio、美国、44122
        • Rapid Medical Research
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • Clinical Research Associates
    • Texas
      • Dallas、Texas、美国、75234
        • Research Across America
      • San Antonio、Texas、美国、78229
        • Clinical Trials of Texas
    • Utah
      • West Jordan、Utah、美国、84088
        • Advanced Clinical Research
    • Washington
      • Seattle、Washington、美国、98101
        • Group Health Research Institute
    • Wisconsin
      • Wausau、Wisconsin、美国、54401
        • Marshfield Clinical Research Foundation

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and who are ambulatory and live in the community or in residential facilities which provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:

    • Absence of changes in medical therapy within one month due to treatment failure or toxicity,
    • Absence of medical events qualifying as SAEs within two months, and
    • Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion unlikely.
  2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
  3. Able to comply with study requirements, including access to transportation for study visits. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
  4. Access to inbound and outbound communication by telephone with caregivers and study staff.

Exclusion Criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
  2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
  3. Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
  4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  5. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  7. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration).
  8. Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
  9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment Group A
RSV-F Vaccine ( 0.5mL Injection)
生物：RSV-F疫苗
安慰剂比较：治疗组B
磷酸盐缓冲液安慰剂（0.5mL 注射液）
生物：磷酸盐缓冲剂安慰剂

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
大体时间：Day 0 to Day 364

Derived/calculated endpoints based on these data will include:

  • Geometric mean concentration as EU (GMEU)
  • Geometric mean ratio (GMR)
  • Seroresponse rate (SRR)
  • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 364
Numbers and percentages of subjects with solicited local and systemic AEs
大体时间：Day 0 to Day 364
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
Day 0 to Day 364

次要结果测量

结果测量
措施说明
大体时间
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
大体时间：Day 0 to Day 182

Summarized by:

  • Geometric mean concentrations (GMC)
  • Geometric mean ratio (GMR)
  • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 182
Neutralizing antibody titer to at least one RSV/A and one RSV/B strain.
大体时间：Day 0 to Day 182

Summarized by:

  • Geometric mean titer (GMT)
  • Geometric mean ratio (GMR)
  • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Day 0 to Day 182

其他结果措施

结果测量
大体时间
Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups.
大体时间：Day 0 to Day 182
Day 0 to Day 182
Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR.
大体时间：Day 0 to Day 182
Day 0 to Day 182

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novavax

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年10月1日

初级完成 (实际的)

2016年11月1日

研究完成 (实际的)

2016年11月1日

研究注册日期

首次提交

2015年10月22日

首先提交符合 QC 标准的

2015年10月29日

首次发布 (估计)

2015年10月30日

研究记录更新

最后更新发布 (实际的)

2022年5月27日

上次提交的符合 QC 标准的更新

2022年5月25日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • RSV-E-202

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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