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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以出现在其他 CRISP 条目中 列出的机构是。 中心，不一定是研究者的机构。 本研究旨在评估针对人乳头瘤病毒 (HPV) 的研究疫苗的安全性和效果。该研究疫苗称为人乳头瘤病毒（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默克研究实验室提供。该研究将研究两种疫苗。事物。 首先，这项研究将检查 QHPV 疫苗的安全性和耐受性。这将通过询问每次注射疫苗后出现的不良（不良）反应来完成。 这项研究要检查的第二件事是，QHPV 疫苗在分 3 剂单独注射时是否可以刺激身体的防御系统形成抗体（身体针对感染或疫苗接种而产生的物质，以帮助抵抗疾病）。这项研究还将检查疫苗中包含的 HPV 类型，看看这些抗体能持续多久。 HPV 感染是美国和全世界最常见的性传播感染 (STI)，HPV 感染会导致生殖器疣和直肠疣，还会导致女性宫颈癌（子宫口癌）。 HPV 感染在感染 HIV 的青少年女孩和男孩中很常见，而 HIV 感染者的 HPV 感染可能更严重且更难治疗。 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，因为该疫苗仅由部分成分制成。病毒，它不会引起 HPV 疾病。