Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)
2012年1月16日 更新者：Sanofi
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.
Subjects will be randomized according to a randomization scheme.
研究概览
地位
完全的
条件
详细说明
All subjects will be followed up for 60 days post-randomization and through the influenza season.
Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point.
The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.
研究类型
介入性
注册 (实际的)
87
阶段
- 阶段1
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
-
-
Florida
-
Miami、Florida、美国、33143
- Miami Research Associates
-
-
Kansas
-
Lenexa、Kansas、美国、66219
- Johnson County Clin-Trials
-
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Washington
-
Tacoma、Washington、美国、98418
- Northwest Kinetics
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-
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
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult males or females 18 - 40 years of age in good general health
Exclusion Criteria:
- Known allergies or severe reactions to any of the vaccine components including those to adjuvants
- History of severe allergic reactions, including angioedema;
- History of asthma or recurrent wheezing; (current or within past 2 years);
- History of neurological symptoms or signs following administration of any vaccine;
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：Study Group 1
ACAM-FLU-A low dose + Adjuvant 1
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
其他名称：
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
其他名称：
0.5 mL ACAM FLU-A low dose, Intramuscular
其他名称：
|
|
实验性的：Study Group 2
ACAM-FLU-A low dose + Adjuvant 2
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
其他名称：
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
其他名称：
0.5 mL ACAM FLU-A low dose, Intramuscular
其他名称：
|
|
实验性的：Study Group 3
ACAM-FLU-A low dose
|
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
其他名称：
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
其他名称：
0.5 mL ACAM FLU-A low dose, Intramuscular
其他名称：
|
|
安慰剂比较：Study Group 4
Saline placebo
|
0.5 mL, Intramuscular
其他名称：
|
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 |
|---|---|---|
|
Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
大体时间：Day 0 through Day 60 post-vaccination
|
Day 0 through Day 60 post-vaccination
|
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 through Day 7 post-vaccination
|
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash.
Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
|
Day 0 through Day 7 post-vaccination
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 through Day 60 post-vaccination 1
|
Day 0 through Day 60 post-vaccination 1
|
|
|
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
大体时间：Day 15 through Month 10 Post-vaccination 1
|
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
|
Day 15 through Month 10 Post-vaccination 1
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
大体时间：Day 15 through Month 10 Post-vaccination 1
|
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ) |
Day 15 through Month 10 Post-vaccination 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Month 4 through Month 10 post-vaccination 1
|
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines.
Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
|
Month 4 through Month 10 post-vaccination 1
|
|
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 and Day 60 Post-vaccination 1
|
Seroconversion was defined as an antibody Titer ≥ 100.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
|
Day 0 and Day 60 Post-vaccination 1
|
|
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 and Day 60 Post-vaccination 1
|
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ). |
Day 0 and Day 60 Post-vaccination 1
|
|
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 and Day 60 Post-vaccination 1
|
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
|
Day 0 and Day 60 Post-vaccination 1
|
|
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 and Day 15 through Month 10 post-vaccination 1
|
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
|
Day 0 and Day 15 through Month 10 post-vaccination 1
|
|
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
大体时间：Day 0 and Day 15 through Month 10 Post-vaccination 1
|
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods |
Day 0 and Day 15 through Month 10 Post-vaccination 1
|
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
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2007年7月1日
初级完成 (实际的)
2009年1月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2008年10月10日
首先提交符合 QC 标准的
2009年1月6日
首次发布 (估计)
2009年1月8日
研究记录更新
最后更新发布 (估计)
2012年1月19日
上次提交的符合 QC 标准的更新
2012年1月16日
最后验证
2012年1月1日
更多信息
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.