CLINICAL TRIAL: PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN P

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。 PACTG P1047是一项针对HIV感染儿童的四价HPV疫苗(qHPV疫苗)的安全性和免疫原性的初步研究。这项研究是评估预防性疫苗的第一步，该疫苗可能会保护感染艾滋病毒的女孩和男孩免受最常见的HPV类型的感染，这些类型会导致肛门生殖发育不良和外生殖器损伤。在这项研究成功完成后，长期目标是在感染艾滋病毒的儿童中进行一项疗效试验，使用qHPV疫苗，以防止疫苗中包含的HPV类型引起的感染和疾病。很可能后续的疗效试验将严重依赖于国际站点。 该方案将在7岁至12岁的儿童中实施，因为这种预防性疫苗很可能会在儿童性行为活跃之前使用。预计，就安全性而言，qHPV疫苗将在7岁至12岁的艾滋病毒感染儿童中普遍耐受性良好。在免疫原性方面，预计在7岁至12岁的艾滋病毒感染儿童的至少一个免疫层中，接种3剂qHPV疫苗方案将具有免疫原性。QHPV疫苗将在7岁至12岁的艾滋病毒感染儿童中普遍耐受性良好。接种3剂qHPV疫苗将在7岁至12岁的HIV感染儿童的至少一个免疫层中具有免疫原性。预计在一个免疫层级中，对每种疫苗HPV类型进行血清转换的艾滋病毒感染者的真实比例将至少为80%。血清转换的定义是，在接种第三剂疫苗后第4周，在基线为相关HPV型阴性的受试者中，每种HPV型的抗体水平高于既定的血清阳性截止值。如果受试者的基线抗体水平低于血清转换截止值，则被认为是未感染。将根据检查已知HPV阴性和低阳性血清的资格计划，为每种HPV类型建立血清分界值。成功的统计学标准要求血清转换受试者比例的95%可信区间下限大于50%。1.了解7岁至12岁HIV感染者接种qHPV疫苗的安全性和耐受性。 2.了解7岁至12岁HIV感染者接种qHPV疫苗后的血清转阴率。

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. PACTG P1047 is a safety and immunogenicity pilot study of quadrivalent HPV vaccine (QHPV Vaccine) in HIV-infected children. This study represents the initial step in evaluating a prophylactic vaccine, which might protect HIV-infected girls and boys from infection with the most common HPV types that cause anogenital dysplasia and external genital lesions. The long-term goal, following successful completion of this study, is to undertake an efficacy trial in HIV-infected children using QHPV Vaccine, in order to prevent infection and disease caused by the HPV types contained in the vaccine. It is likely that a follow-up efficacy trial will rely heavily on international sites. This protocol will be undertaken in children > 7 to < 12 years of age because it is likely that this preventative vaccine will be used before children become sexually active. It is expected that, in terms of safety, QHPV Vaccine will be generally well-tolerated in HIV-infected children > 7 to < 12 years of age. In terms of immunogenicity, administration of a 3-dose regimen of QHPV Vaccine is expected to be immunogenic in at least one immune stratum of HIV-infected children > 7 to < 12 years of age. QHPV Vaccine will be generally well-tolerated in HIV-infected children >7 to <12 years of age. Administration of a 3-dose regimen of QHPV Vaccine will be immunogenic in at least one immune stratum of HIV-infected children > 7 to < 12 years of age. It is anticipated that the true proportion of HIV-infected subjects who will seroconvert for each vaccine HPV type will be at least 80% in one immune strata. Seroconversion is defined as the development of antibody levels above the established seropositivity cutoff for each HPV type at Week 4 post-administration of the third dose, in subjects who were na¿¿ve at baseline to the relevant HPV type. Subjects were considered na¿¿ve if their baseline antibody level was less than the seroconversion cutoff. Sero-cutoff values will be established for each HPV type based on a qualification plan examining known HPV-negative and low positive sera. The statistical criterion for success requires that the lower bound of 95% CI for the proportion of subjects who seroconvert be greater than 50%. 1. To determine the safety and tolerability of QHPV Vaccine in HIV-infected children ages > 7 to < 12 years. 2. To determine seroconversion after vaccination with QHPV Vaccine in HIV-infected children ages > 7 to < 12 years.