A5240 (VERSION 10) A PHASE II STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 感染艾滋病毒的人寿命更长，而非艾滋病定义的疾病可能会越来越多地影响这一人群。人乳头瘤病毒感染在感染艾滋病毒的妇女中更为普遍和持久，其患病率为%，而在艾滋病毒阴性的妇女中为28%。然而，在一项对146名接受HAART治疗的未接受治疗的妇女的研究中，16型和18型HPV的患病率在基线时分别为16%和11%(私人交流，Kenneth Fife，印第安纳大学医学中心，2007年9月)。此外，在HER的研究中，评估了767名艾滋病毒感染者和390名非感染者，其中一种或多种HPV 6型、11型、16型和18型的DNA流行率为15.9%；具体地说，6型为3.1%，11型为0.9%，16型为5.7%，18型为6.1%(HIV阴性妇女为6.7%)。因此，尽管艾滋病毒感染妇女的这四种类型的流行率比艾滋病毒阴性妇女高得多，但她们中的大多数(84-89%)没有疫苗中包含的类型。预防感染四种HPV疫苗可以减少HPV感染对艾滋病毒感染者的影响。到目前为止，人类乳头瘤病毒疫苗在感染艾滋病毒的成年人中的免疫原性和安全性尚未得到研究。这项研究是在成年感染艾滋病毒的女性中评估HPV疫苗的第一步。 首要目标 目的：确定在四价HPV重组疫苗系列接种后，HPV6、11、16和18型特异性血清阳性水平以上的每个CD4+细胞计数层中抗体滴度的发展。

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. HIV-infected individuals are living longer, and non-AIDS-defining conditions are likely to affect this population in increasing numbers. HPV infections are more prevalent and persistent in HIV-infected women, with a prevalence of 64% compared to 28% in HIV-negative women. However, in a study of 146 treatment na¿ve women initiating HAART, the prevalence of HPV types 16 and 18 was 16% and 11%, respectively, at baseline (personal communication, Kenneth Fife, Indiana University Medical Center, September 2007). Additionally, in the HER study, evaluating 767 HIV-infected and 390 non-infected women, the DNA prevalence of one or more of HPV types 6, 11, 16, and 18 was 15.9%; specifically, type 6 was 3.1%, 11 was 0.9%, 16 was 5.7%, and 18 was 6.1% (6.7% in HIV-negative women). Thus, although HIV-infected women have a much higher prevalence of these four types than HIV-negative women, the majority of them (84-89%) did not have the types contained in the vaccine. Preventing infection of the four vaccine HPV types could decrease the impact of HPV infection among HIV-infected individuals. To date, the immunogenicity and safety of an HPV vaccine in HIV-infected adults has not been studied. This study is an initial step in evaluating an HPV vaccine in adult HIV-infected females. Primary Objective To determine the development of titers in each CD4+ cell count stratum of antibodies to HPV 6, 11, 16, and 18 above a level of type-specific seropositivity after the quadrivalent HPV recombinant vaccine series.