FLUZONE? IM INTRAMUSCULAR VACCINATION WITH FLUZONEIN HEALTHY ADULTS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。流感可在所有年龄组中引起急性呼吸道疾病，但对慢性疾病患者、免疫功能低下患者和老年患者尤其有害。接种流感疫苗是一项重要的公共卫生措施，有助于预防与流感有关的发病率和死亡率，但在2004-2005年流感季节，由于生产问题，美国几乎损失了一半的流感疫苗供应。因此，迫切需要能够扩大流感疫苗供应的方法。以往的动物和人类研究经验表明，通过皮内（ID）途径递送抗原可以启动有效的免疫反应。与肌内途径（IM）相比，需要较少的抗原来引起相似水平的免疫反应。目前的研究旨在评估三价灭活流感疫苗的免疫原性和安全性，当通过ID途径给药时，与IM给药相比。这是一项II期研究，涉及多达10个研究点，将招募多达1528名18-64岁的健康成年人。斯坦福大学医学中心将招募大约150名志愿者。受试者将被随机分配，通过ID途径接种一剂三价灭活流感疫苗（TIV）[每种菌株的6克或9克血凝素（HA）由Becton-Dickenson (BD) ID系统接种，或3克Fluzone由Mantoux技术接种]。这些组将与通过标准IM途径接受15克（HA/株）剂量的Fluzone¿的个体进行比较。研究疫苗将采用2004-2005年的配方。免疫原性研究将在免疫接种前和免疫接种后三周抽取血液样本进行免疫原性分析。与IM相比，TIV管理ID的安全性概况和受试者可接受性也将进行评估。在研究结束后，所有受试者都将获得一剂2005-2006年Fluzone¿IM。

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.