Global GAS Vaccine Based On The M-Protein
Global GAS Vaccine Based On The M-Protein
批准号:
6803876
负责人:
Michael F Good
金额:
$53.8万
依托单位国家:
美国
项目类别:
财政年份:
2004
资助国家:
美国
项目状态:
已结题
起止时间:
2004-09-15 至 2009-08-31
关键词:
AustraliaPacific IslandsStreptococcus pyogenesanimal genetic material tagantibody formationbacterial antigensbacterial vaccinesbiotechnologyclinical researchclinical trial phase Icommunicable disease controlcooperative studydrug quality /standardechocardiographyenzyme linked immunosorbent assayepidemiologyfield studyhuman subjecthuman therapy evaluationimmune responseinhalation drug administrationlaboratory mousemiddle childhood (6-11)patient oriented researchpediatric pharmacologypermeasepharyngitisrheumatic feverrheumatic heart diseaseserology /serodiagnosisvaccine developmentvaccine evaluationwestern blottings
中文摘要
描述(由申请人提供):
化脓性链球菌(Streptococcus pyogenes),也称为A组链球菌(Group A Streptococcus,GAS),是革兰氏阳性细菌病原体,其引起许多疾病,包括相对良性的咽炎和皮肤感染,严重的侵袭性疾病包括坏死性筋膜炎和感染后后遗症风湿热、风湿性心脏病和肾小球肾炎。目前,还没有在欠发达国家证明有效的初级预防战略,因此显然需要疫苗。正在制定的一些疫苗战略在欠发达国家可能无效。我们的长期目标是开发广谱全球疫苗,预防GAS感染及其相关疾病,包括风湿热。我们的GAS候选疫苗是基于来自M蛋白保守区的肽抗原。 我们有四种使用这种抗原的潜在疫苗构建体,每一种都在临床前研究中显示出良好的免疫原性、安全性和保护性。
当前应用程序中的工作有三个总体目标:
(1)我们最先进的结构进展到临床试验。 在这项工作结束时,我们预计将完成:
(a)在澳大利亚成人志愿者中进行的初步I期试验。
(b)一项在澳大利亚成年志愿者和
发展中国家。
(c)在发展中国家的儿童志愿者中进行的小型I期试验。
(2)保守区肽作为鼻内疫苗的进一步开发。
(3)在发展中国家进行实地研究,以确定可分阶段使用的保护相关因素 II和III的保守区肽的临床试验,并建立一个领域的网站,这些后期阶段的试验。
英文摘要
DESCRIPTION (provided by applicant):
Streptococcus pyogenes which is also known as Group A Streptococcus (GAS) is a Gram positive bacterial pathogen that is responsible for numerous diseases including relatively benign pharyngitis and skin infections to serious invasive diseases including necrotizing fasciitis and the post-infectious sequelae rheumatic fever, rheumatic heart disease and glomerulonephritis. Presently, there is no strategy for primary prevention that is proven to work in less-developed countries, so a vaccine is clearly needed. Some vaccine strategies under development may not be effective in less developed countries. Our long-term goal is the development of broad-spectrum global vaccine that prevents GAS infection and its associated diseases, including rheumatic fever. Our GAS vaccine candidate is based on a peptide antigen from the conserved region of the M-protein. We have four potential vaccine constructs that use this antigen, each of which has shown good immunogenicity, safety and protection in pre-clinical studies.
There are three overall objectives for the work in the current application:
(1) Progression of the most advanced of our constructs to clinical trials. At the conclusion of this work, we expect to have completed:
(a) An initial phase I trial in adult volunteers in Australia.
(b) A larger multicentre phase I trial in adult volunteers in Australia and adult volunteers in a
developing country.
(c) A small phase I trial in child volunteers in a developing country.
(2) Further development of the conserved region peptide as an intranasal vaccine.
(3) Field studies in a developing country to establish correlates of protection that may be used in phase II and III clinical trials of the conserved region peptide, and to establish a field site for these later-phase trials.
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Global GAS Vaccine Based On The M-Protein
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批准号:7286011
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项目类别:
-
资助金额:$59.13万
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财政年份:2004
-
负责人:Michael F Good
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依托单位:
Global GAS Vaccine Based On The M-Protein
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批准号:6946934
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项目类别:
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资助金额:$53.97万
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财政年份:2004
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负责人:Michael F Good
-
依托单位:
Global GAS Vaccine Based On The M-Protein
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批准号:7112333
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项目类别:
-
资助金额:$59.96万
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财政年份:2004
-
负责人:Michael F Good
-
依托单位:
Global GAS Vaccine Based On The M-Protein
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批准号:7493529
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项目类别:
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资助金额:$51.29万
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财政年份:2004
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负责人:Michael F Good
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依托单位:
海外基金