Live attenuated vaccines for pandemic preparedness

申请者摘要：流感大流行，可能更具破坏性 比许多其他公认的传染病威胁更大的威胁 时间到了。正因为如此，国际和美国政府 制定预防大流行的计划，以便能够应对、控制传播 控制病毒，减少疾病。实现这些目标的一种方法是 通过使用疫苗。这项研究将评估 开发、制造和分发一种活的、减毒的疫苗 来自禽源的流感毒株(S)，最终可能是 在人类身上进行了测试，以备在流感大流行期间使用。这项研究 将开始评估用活的、减毒的疫苗接种的假设 基于大流行病毒株的疫苗可能成为可行和实用的 控制大流行性流感传播的方法。以冷适应为基础 和基因工程技术，Aviron正在开发一种活的、减毒的 一般用于预防流感的鼻腔疫苗。施药 这些技术通过开发疫苗来预防大流行 候选人，以及增强相关技术能力以支持 广泛接种疫苗的可行性，标志着NIH的潜在价值 格兰特。具体地说，计划是： -生产两种主要病毒种子 -描述重组剂的特征并评估其安全性 -制造候选疫苗，以确保适合人体测试 -确定疫苗生产时间的改进 -为快速、高效的分发和 大规模免疫规划中的管理； -起草临床试验方案，以确定安全性和免疫原性。

APPLICANT'S ABSTRACT: An influenza pandemic, which could be more devastating than many other recognized infectious disease threats, could strike at any time. Because of this fact, international and United States governments are creating Pandemic Preparedness plans to be able to respond, control the spread of the virus, and reduce illness. One way of achieving these goals would be through the use of vaccines. This research will evaluate the feasibility of developing, manufacturing, and distributing a live, attenuated vaccine for strain(s) of influenza derived from avian sources, which could ultimately be tested in humans for potential use during an influenza pandemic. The research will begin to evaluate the hypothesis that vaccination with a live, attenuated vaccine based on a pandemic virus strain could become a feasible and practical way of controlling the spread of pandemic influenza. Based on cold-adaptation and genetic engineering technologies, Aviron is developing a live, attenuated intranasal vaccine for general use in the prevention of influenza. Applying these technologies to pandemic preparedness efforts by developing a vaccine candidate, along with augmenting related technical capabilities to support the feasibility of widespread vaccination, signify the potential worth of the NIH grant. Specifically, the plan is to: - Produce two Master Virus Seeds - Characterize the reassortants and evaluating them for safety - Manufacture the vaccine candidate to ensure suitability for human testing - Identify improvements to vaccine production timing - Model the methods required for rapid, efficient distribution and administration in mass immunization programs; - Draft a clinical trial protocol to establish the safety and immunogenicity.