PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS

四价人乳头病毒的二期安全性和免疫原性研究

• 批准号: 7607923
• 负责人: Sharon A Nachman
• 金额: $ 0.57万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-23 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607923
• 关键词: Adult; Antibodies; Cancer Etiology; Child; Computer Retrieval of Information on Scientific Projects Database; Disease; Dose; Female Adolescents; Funding; Gardasil; Genital system; Grant; HIV Infections; Human; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 6; Infection; Institution; Laboratory Research; Malignant neoplasm of cervix uteri; Papillomavirus; Phase; Placebos; Rectum; Research; Research Personnel; Resources; Safety; Sexually Transmitted Diseases; Source; System; Testing; United States; United States Food and Drug Administration; United States National Institutes of Health; Uterus; Vaccination; Vaccines; Virus; Virus Diseases; Virus-like particle; Woman; boys; experience; fighting; girls; immunogenicity; penis; rectal; response

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.

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。 这项研究是为了评估一种针对人乳头瘤病毒（HPV）的研究性疫苗的安全性和有效性。 研究疫苗被称为人乳头瘤病毒（6、11、16、18型）L1病毒样颗粒[VLP]疫苗（QHPV疫苗，也称为GARDASIL？）。 本研究中使用的疫苗和安慰剂均由Merck Research Laboratories提供。 这项研究将关注两件事。 首先，本研究将检查QHPV疫苗的安全性和耐受性。 这将通过询问每次接种疫苗后经历的不良（坏）影响来完成。 这项研究将检查的第二件事是，QHPV疫苗在3次单独给药时，是否可以刺激身体的防御系统形成抗体（身体对感染或疫苗接种做出反应以帮助抵抗疾病的物质）疫苗中包含的每种HPV类型。 这项研究还将检查这些抗体将持续多久。 HPV感染是美国和全世界最常见的性传播感染（STI）。 HPV感染会导致生殖器和直肠疣。 它也会导致女性宫颈癌（子宫开口），也会导致直肠和阴茎周围的癌症。 HPV感染在感染艾滋病毒的青春期女孩和男孩中很常见。 HPV感染在HIV感染者中可能更严重，更难治疗。 这项研究是评估一种疫苗的第一步，这种疫苗可能会保护艾滋病毒感染的女孩和男孩免受HPV感染。 QHPV疫苗尚未获得FDA批准，但已在健康成人中进行了安全测试。 它还在没有感染艾滋病毒的儿童中进行了测试。 由于疫苗只含有部分病毒，因此不会引起HPV疾病。