A PHASE I STUDY OF INACTIVATED VERO CELL-CULTURE INFLUENZA A/H5N1 GIVEN ALONE

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是评估一种新型Vero细胞培养物衍生的全病毒（WV）A/H5 N1流感疫苗在不同剂量水平（含或不含氢氧化铝佐剂）下经肌肉（IM）注射给药至健康成人时的安全性、反应原性和免疫原性。我们假设剂量水平在7.5 mg至15 mg范围内的含佐剂WV甲型流感/H5 N1疫苗或剂量水平在7.5 mg至45 mg范围内的无佐剂WV甲型流感/H5 N1疫苗将具有良好的耐受性，并且当以2剂方案施用时将产生可接受的免疫原性。此外，我们假设当比较相似剂量水平的含佐剂和无佐剂疫苗（基于HA含量）时，添加氢氧化铝佐剂将显著增强疫苗的免疫原性。

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. The goals of this study are to assess the safety, reactogenicity, and immunogenicity of a novel Vero cell culture-derived whole virus (WV) influenza A/H5N1 vaccine at various dosage levels with or without aluminum hydroxide adjuvant when administered by intramuscular (IM) injection to healthy adults. We hypothesize that a dosage level in the range of 7.5 mg to 15 mg of adjuvanted WV influenza A/H5N1 vaccine, or a dosage level on the range of 7.5 mg to 45 mg of nonadjuvanted WV influenza A/H5N1 vaccine will be well tolerated and will result in acceptable immunogenicity when administered in a 2-dose regimen. Further, we hypothesize that addition of aluminum hydroxide adjuvant will significantly enhance the immunogenicity of the vaccine when similar dosage levels of adjuvanted and nonadjuvanted vaccine (based on HA content) are compared.