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EVALUATION OF A BOOSTER DOSE OF A/VIETNAM/1203/04 (H5N1) VACCINE ADMINISTERED

EVALUATION OF A BOOSTER DOSE OF A/VIETNAM/1203/04 (H5N1) VACCINE ADMINISTERED
A/VIETNAM/1203/04 (H5N1) 疫苗加强剂量的评估
批准号:
7376102
负责人:
Kenneth Mathew Zangwill
金额:
$1.12万
依托单位国家:
美国
项目类别:
财政年份:
2005
资助国家:
美国
项目状态:
已结题
起止时间:
2005-12-01 至 2006-11-30

项目摘要

项目成果

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中文摘要
翻译
该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者(PI)可能从另一个NIH来源获得了主要资金,因此可以在其他CRISP条目中表示。所列机构为中心,不一定是研究者所在机构。流行性感冒(流感)是由几种相关病毒引起的常见感染。在美国,每年有20,000 - 40,000人死亡。当一种新的流感病毒感染人类时,感染可以迅速蔓延到世界各地。一些新的人类流感病毒来自禽流感病毒。最近,一些禽流感病毒株感染了亚洲的人。其中一种流感病毒被称为A/H5 N1。 疫苗可以预防感染和疾病。疫苗通过使身体产生称为抗体的蛋白质来对抗感染。有时需要一剂以上的疫苗,以便身体产生足够的抗体来对抗感染。已经开发了一些疫苗来预防流感病毒感染。流感疫苗可以预防流感及其引起的健康问题。这些疫苗是由杀死的流感病毒的一部分制成的。这些疫苗是作为一种“注射剂”给你的。你以前参加过一项研究,测试一种针对A/H5 N1禽流感病毒的实验性疫苗。作为本研究的一部分,您接种了两剂A/H5 N1禽流感疫苗。A/H5 N1禽流感疫苗被认为是研究性的(或实验性的),这意味着它还没有被美国食品和药物管理局批准用于公众。疫苗由赛诺菲巴斯德公司生产。(以前称为Aventis Pasteur,Inc.)。 这项研究的目的是要找出是否给予第三剂A/H5 N1疫苗将提高人体的禽流感抗体(细菌战斗机)的水平。这项研究的信息将有助于研究人员和公共卫生官员确定需要多少剂量的A/H5 N1疫苗才能产生最佳的禽流感保护水平。 来自美国3个研究中心(洛杉矶)的约450名个体。生物医学研究所、罗切斯特大学和马里兰州大学)参加了早些时候的一项研究,以测试A/H 5 N 1禽流感疫苗。大约400名接受了两剂A/H5 N1禽流感疫苗(而不是安慰剂或非活性疫苗)并且目前健康的人将被要求参加这项研究。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Influenza (the flu) is a common infection caused by several related viruses. It is responsible for 20,000-40,000 deaths each year in the United States. When a new strain of flu infects people, the infection can spread around the world quickly. Some of the new human flu viruses come from bird flu viruses. Recently, some strains of bird flu viruses have infected people in Asia. One of these flu strains is called A/H5N1. Vaccines can prevent infection and disease. Vaccines work by causing the body to make proteins called antibodies that fight infection. Sometimes more than 1 dose of vaccine is needed so that the body will make enough antibodies to fight infection. Some vaccines have been developed to prevent infection with flu viruses. Flu vaccines protect against flu and the health problems it causes. These vaccines are made from parts of killed flu virus. These vaccines are given as a "shot" in the arm. Your have previously taken part in a research study to test an experimental vaccine against the A/H5N1 bird flu virus. As part of this study, you received two doses of the A/H5N1 bird flu vaccine. The A/H5N1 bird flu vaccine is considered investigational (or experimental) which means that it has not been approved by the U.S. Food and Drug Administration for use in the general public. The vaccine is made by sanofi pasteur, inc. (previously known as Aventis Pasteur, Inc.). The purpose of this study is to find out if giving a third dose of the A/H5N1 vaccine will boost the body's level of bird flu antibodies (germ fighters). Information from this study will help researchers and public health officials to determine how many doses of A/H5N1 vaccine will be needed to produce the best level of protection against bird flu. About 450 individuals from 3 study sites in the United States (L.A. Biomedical Research Institute, University of Rochester and University of Maryland) took part in a the earlier research study to test the A/H5N1 bird flu vaccine. About 400 individuals who received two doses of the A/H5N1 bird flu vaccine (not the placebo or inactive shot) and are currently healthy will be asked to take part in this study.
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A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, PHASE I/II, DOSE-RANGING STUDY
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