PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS

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。 这项研究是为了评估人乳头瘤病毒(HPV)研究疫苗的安全性和效果。研究中的疫苗被称为人乳头状瘤病毒(6型、11型、16型、18型)L1病毒样颗粒[VLP]疫苗(qHPV疫苗，也称为Gardasil)。这项研究中使用的疫苗和安慰剂都将由默克研究实验室提供。这项研究将着眼于两件事。 首先，这项研究将检查qHPV疫苗的安全性和耐受性。这将通过询问每次接种疫苗后所经历的不良(不良)影响来实现。 这项研究将检查的第二件事是，当qHPV疫苗分三次接种时，是否可以刺激人体的防御系统，以形成针对疫苗中包含的每一种HPV类型的抗体(身体为应对感染或接种疫苗而产生的物质)。这项研究还将检查这些抗体能持续多久。 HPV感染是美国和世界范围内最常见的性传播感染(STI)。HPV感染会导致生殖器和直肠尖锐湿疣。它还会导致女性的子宫颈癌(子宫开口)，也可能导致直肠和阴茎周围的癌症。HPV感染在感染艾滋病毒的青少年女孩和男孩中很常见。在艾滋病毒感染者中，HPV感染可能更严重，更难治疗。这项研究是评估一种可能保护感染艾滋病毒的女孩和男孩免受HPV感染的疫苗的第一步。QHPV疫苗尚未获得FDA的批准，但已在健康成年人身上进行了安全测试。它也已经在没有感染艾滋病毒的儿童身上进行了测试。由于疫苗只用部分病毒制成，它不会导致HPV疾病。

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 study is being done to evaluate the safety and effect of an investigational vaccine against human papilloma virus (HPV). The investigational vaccine is called Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle [VLP] Vaccine (QHPV Vaccine, also known as GARDASIL¿). Both the vaccine and placebo used in this study will be provided by Merck Research Laboratories. The study will look at two things. First, this study will examine the safety and tolerability of the QHPV Vaccine. This will be done by asking about adverse (bad) effects experienced after each shot of the vaccine. The second thing that this study will examine is whether the QHPV vaccine, when given in 3 separate doses, can stimulate the body's defense system to form antibodies (substances the body make in response to an infection or vaccination to help fight off disease) to each HPV type contained in the vaccine. This study will also check to see how long these antibodies will last. HPV infection is the most common sexually transmitted infection (STI) in the United States and worldwide. HPV infection causes genital and rectal warts. It also causes cancer of the cervix (opening of the uterus) in women, and can also cause cancer around the rectum and penis. HPV infection is common in HIV-infected adolescent girls and boys. HPV infection can be more severe and harder to treat in HIV-infected people. This study is the first step in evaluating a vaccine that might protect HIV-infected girls and boys from infection with HPV. The QHPV Vaccine has not been approved by the FDA, but has been safely tested in healthy adults. It has also been tested in children without HIV infection. Since the vaccine is made with only part of a virus, it cannot cause the HPV disease.