EVALUATION OF A BOOSTER DOSE OF A/VIETNAM/1203/04 (H5N1) VACCINE ADMINISTERED

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。 本提案描述了一项在约400名18-65岁（含）健康成人中进行的A/H5 N1流感疫苗多中心、随机、双盲研究。参与者将已经参加了该疫苗的早期研究（项目10410-01[104]），并接受了两剂A/H5 N1疫苗，间隔一个月。在早期研究中接受安慰剂的受试者将不参加。研究10410-01（104）的最终访视将与本研究10410-01（108）的首次访视同时进行。 在该研究中心，预计最多140名成人将有资格参加本研究。受试者将接受一次上臂肌肉注射A/H5 N1流感疫苗的单次注射，剂量与先前研究中接受的剂量相同（7.5、15、45或90 μ g）。第三次注射将在先前接受第二次注射后约6个月。所有研究工作人员均将设盲，但未设盲的护士接种员除外。 参与者将接受疫苗注射，然后进行为期7天的安全性评估。 接种后15-30分钟在门诊评估症状和体征，受试者将保留日记卡（也称为记忆辅助工具），记录免疫后7天的口腔温度和全身和局部不良事件（AE）。 所有受试者将在接种后1-3天和1 - 3 -19天接受安全性电话随访，以收集AE信息。 接种后28天和180天将采集血样，以测量疫苗产生的抗体。（将采集接种前血样作为研究10410-01的最终研究活动[104]）。 抗体检测将在中心实验室进行。 主要结局指标将是每个剂量组中AE的频率和严重程度以及达到预定水平的A/H5 N1流感保护性抗体的受试者比例。

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. This proposal describes a multicenter randomized, double-blinded, study of A/H5N1 influenza vaccine in approximately 400 healthy adults 18-65 years of age, inclusive. Participants will have already taken part in an earlier study of this vaccine (Project 10410-01[104]) and received two doses of the A/H5N1 vaccine, one month apart. Participants who received placebo in the earlier study will not participate. The final visit for study 10410-01(104) will be conducted at the same time as the first visit for this study 10410-01(108). At this site, it is anticipated that up to 140 adults will be eligible to take part in the study. Participants will receive a single injection of the same dose of the A/H5N1 influenza vaccine that they received in the earlier study (either 7.5, 15, 45, or 90 ¿g) by intramuscular injection in the upper arm. This third dose will be approximately 6 months after the previously received second dose. All study staff will be blinded except the unblinded nurse vaccinator. Participants will receive the vaccine injection followed by a 7-day safety assessment period. Symptoms and signs will be assessed in the clinic for 15-30 minutes after inoculation, and the subjects will maintain a diary card (also called a memory aid) to record oral temperature and systemic and local adverse events (AE) for 7 days after the immunization. All subjects will receive a safety follow-up telephone call at 1-3 days and 13-19 days after vaccination to collect AE information. A blood sample will be obtained 28 days and 180 days after vaccination to measure the antibodies produced by the vaccine. (A pre-vaccination blood sample will have been collected as the final study activity for study 10410-01[104]). The antibody tests will be performed in a central laboratory. The primary outcome measures will be the frequency and severity of AEs in each dose group and the proportions of subjects who achieve a predefined level of protective antibody against A/H5N1 flu.