Development of an Ad14 Vaccine

描述(由申请人提供)：最近的报告表明，一种新的腺病毒血清14型(AD14)株正在导致频繁的急性呼吸道疾病(ARD)和其他健康人的死亡。这项SBIR的总体目标是生产一种能够预防AD14感染和疾病的疫苗。我们的假设是，通过删除E1区Ad14nr而使AD14载体颗粒不能复制的Ad14nr将是一种有效和安全的疫苗。已经获得了支持这一战略的初步数据。在这项应用的第一阶段，我们将通过生产Ad14nr原型疫苗、测试其产量和生产质量、评估免疫原性和初步安全性测试来测试我们策略的可行性。在SBIR的第二阶段，我们将根据良好的制造规范进行IND支持的生产和质量测试，并完成所需的安全和生物分布研究。公共卫生相关性：最近的报告表明，一种新的14型腺病毒(AD14)株正在导致频繁的急性呼吸道疾病(ARD)和其他健康人群的死亡。这项SBIR的总体目标是生产一种能够预防AD14感染和疾病的疫苗。

DESCRIPTION (provided by applicant): Recent reports indicate that a new strain of adenovirus serotype 14 (Ad14) is causing frequent acute respiratory disease (ARD) and deaths in otherwise health people. The overall goal of this SBIR is to generate a vaccine that can protect against Ad14 infection and disease. Our hypothesis is that an Ad14 vector particle that is made non-replicating by means of a deletion in the E1 region, Ad14nr, will be an effective and safe vaccine. Preliminary data supporting this strategy has been obtained. In the phase I portion of this application we will test the feasibility of our strategy by generating an Ad14nr prototype vaccine, testing its yield and quality of production, evaluating immunogenicity and initial testing for safety. In the phase II portion of this SBIR we will conduct IND enabling production and quality testing under Good Manufacturing Practice and complete required safety and biodistribution studies. PUBLIC HEALTH RELEVANCE: Recent reports indicate that a new strain of adenovirus serotype 14 (Ad14) is causing frequent acute respiratory disease (ARD) and deaths in otherwise healthy people. The overall goal of this SBIR is to generate a vaccine that can protect against Ad14 infection and disease.