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。 艾滋病毒感染者的寿命更长，非艾滋病定义的条件可能会影响越来越多的人。HPV感染在感染艾滋病毒的妇女中更为普遍和持久，患病率为64%，而艾滋病毒阴性妇女为28%。然而，在一项对146名初次接受HAART治疗的女性进行的研究中，基线时HPV 16型和18型的患病率分别为16%和11%（个人交流，Kenneth Fife，印第安纳州大学医学中心，2007年9月）。此外，在HER研究中，评估了767名HIV感染和390名未感染女性，HPV 6、11、16和18型中一种或多种的DNA患病率为15.9%;具体而言，6型为3.1%，11型为0.9%，16型为5.7%，18型为6.1%（HIV阴性女性为6.7%）。因此，尽管感染艾滋病毒的妇女这四种类型的流行率比艾滋病毒阴性妇女高得多，但其中大多数（84-89%）没有疫苗中所含的类型。预防四种HPV疫苗类型的感染可以减少HPV感染对HIV感染者的影响。迄今为止，尚未研究HPV疫苗在HIV感染成人中的免疫原性和安全性。这项研究是评估成年HIV感染女性HPV疫苗的第一步。 主要目的 确定四价HPV重组疫苗系列接种后，各CD 4+细胞计数分层中HPV 6、11、16和18抗体的滴度是否高于型特异性血清阳性水平。

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.