CLINICAL TRIAL: A DOUBLE-BLIND, RANDOMIZED, CONTROLLED PHASE III STUDY TO ASSESS

临床试验：双盲、随机、对照 III 期研究进行评估

• 批准号: 7716566
• 负责人: Gregory James Mertz
• 金额: $ 17.4万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716566
• 关键词: Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Double-Blind Method; Frequencies; Funding; Genital system; Grant; Herpesvirus 1; Human Herpesvirus 2; Immune; Infection; Institution; Phase; Randomized; Recurrence; Research; Research Personnel; Resources; Simplexvirus; Source; United States National Institutes of Health; Vaccines; Woman; aluminum sulfate; genital herpes; prevent

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 primary objective of this study is to determine whether gDt-alum-MPL vaccine protects women who are HSV-1 (herpes simplex virus) and HSV-2 negative against genital herpes caused disease caused by either HSV1 or HSV2. The secondary objectives are to (a) determine whether gDt-alum-MPL vaccine prevents HSV-1 and HSV-2 negative women from acquiring HSV1 or HSV2 infection, reduces HSV shedding following HSV-2 seroconversion, reduces the frequency of recurrent genital herpes disease, or prevents oro-labial disease, and (b) to assess potential correlates of immune protection for HSV-2 genital disease and HSV-2 infection.

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。子项目和 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。 本研究的主要目的是确定gDt-alum-MPL疫苗是否可保护HSV-1（单纯疱疹病毒）和HSV-2阴性的女性免受HSV 1或HSV 2引起的生殖器疱疹引起的疾病。次要目的是（a）确定gDt-alum-MPL疫苗是否可预防HSV-1和HSV-2阴性女性获得HSV-1或HSV-2感染，减少HSV-2血清转换后的HSV脱落，降低复发性生殖器疱疹疾病的频率，或预防口唇疾病，以及（B）评估HSV-2生殖器疾病和HSV-2感染的免疫保护的潜在相关性。