FLUZONE? IM INTRAMUSCULAR VACCINATION WITH FLUZONEIN HEALTHY ADULTS

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来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。流感在所有年龄组中引起急性呼吸道疾病，但在患有慢性疾病的个体、免疫功能低下的患者和极端年龄的患者中尤其虚弱。接种流感疫苗是一项重要的公共卫生措施，以帮助预防与流感相关的发病率和死亡率，但在2004-2005年流感季节，由于生产问题，美国几乎一半的流感疫苗供应丢失。因此，迫切需要扩大流感疫苗供应的方法。先前的动物和人类研究经验表明，通过皮内（ID）途径递送抗原可引发有效的免疫应答。与肌内途径（IM）递送相比，引发类似水平的免疫应答需要较少的抗原。本研究旨在评价三价灭活流感疫苗通过ID途径接种与IM接种相比的免疫原性和安全性。这是一项II期研究，涉及多达10个研究中心，将入组多达1528名18-64岁的健康成人。斯坦福大学医学中心将招募大约150名志愿者。 受试者将随机接受一剂ID途径的三价灭活流感疫苗（TIV）[通过Becton-Dickenson（BD）ID系统给予每种毒株6 μ g或9 μ g血凝素（HA）或通过Mantoux技术给予3 μ g Fluzone]。将这些组与通过标准IM途径接受15 g（HA/菌株）剂量Fluzone的个体进行比较。研究疫苗为2004-2005年制剂。在免疫前和免疫后3周采集用于免疫原性研究的血样，用于免疫原性测定。还将评价与IM相比，TIV ID给药的安全性特征和受试者可接受性。研究完成后，将为所有受试者提供2005-2006 Fluzone？IM给药。

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 causes acute respiratory illnesses in all age group, but is particularly debilitating in individuals with chronic diseases, in immunocompromised patients and in those at extreme of age. Vaccination against influenza virus is an important public health measure to help protect against morbidity and mortality associated with influenza, but during the 2004-2005 flu season, almost half of the US supply of influenza vaccine was lost due to a manufacturing problem. Therefore, methods that can expand the flu vaccine supply are desperately needed. Previous experience with animal and human studies showed that delivery of antigens via the intradermal (ID) route can initiate an efficient immune response. As compared to the intramuscular route (IM) of delivery, less antigen would be required to elicit similar levels of immune response. The current study is designed to evaluate the immunogenicity and safety of a trivalent inactivated influenza vaccine when administered via the ID route as compared to IM administration. This is a Phase II study involving up to 10 study sites and will enroll up to 1528 healthy adults of age 18-64. Stanford University Medical Center will enroll approximately 150 volunteers. Subjects will be randomized to receive one dose of trivalent inactivated influenza vaccine (TIV) by ID route [either 6 ¿g or 9 ¿g hemagglutinin (HA) of each strain administered by the Becton-Dickenson (BD) ID system or 3 ¿g of Fluzone¿ administered by the Mantoux technique]. These groups will be compared to individuals receiving a 15 ¿g (HA/strain) dose of Fluzone¿ by the standard IM route. The study vaccines will be of the 2004-2005 formulation. Blood samples for immunogenicity studies will be drawn prior to immunizatin and three weeks post-immunization for immunogenicity assays. Safety profile and subject acceptability of the TIV adminstered ID as compared to IM will also be evaluated. All subjects will be offered a dose of 2005-2006 Fluzone¿ IM following the completion of the study.