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

该子项目是利用 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。列出的机构是 中心，不一定是研究者的机构。 PACTG P1047是四价HPV疫苗（QHPV疫苗）在HIV感染儿童中的安全性和免疫原性初步研究。 这项研究代表了评估预防性疫苗的第一步，该疫苗可能会保护HIV感染的女孩和男孩免受最常见的HPV类型的感染，这些HPV类型会导致肛门生殖器发育不良和外生殖器病变。 在成功完成本研究后，长期目标是在HIV感染儿童中使用QHPV疫苗进行有效性试验，以预防疫苗中所含HPV类型引起的感染和疾病。 随访疗效试验很可能严重依赖国际研究中心。 该方案将在> 7至< 12岁的儿童中进行，因为这种预防性疫苗可能会在儿童性活跃之前使用。 就安全性而言，QHPV疫苗在> 7至< 12岁的HIV感染儿童中的耐受性通常良好。 在免疫原性方面，预期QHPV疫苗的3剂方案的施用在&gt; 7至7至7至&lt; 12岁的HIV感染儿童的至少一个免疫层中具有免疫原性< 12 years of age. QHPV Vaccine will be generally well-tolerated in HIV-infected children ><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 >。 预计在一个免疫分层中，每种疫苗HPV类型血清转化的HIV感染受试者的真实比例至少为80%。 血清转换定义为在基线时未感染过相关HPV类型的受试者中，在第三剂给药后第4周，每种HPV类型的抗体水平高于确定的血清阳性临界值。 如果受试者的基线抗体水平低于血清转换临界值，则认为受试者未经治疗。 将根据检查已知HPV阴性和低阳性血清的确认计划，确定每种HPV类型的血清临界值。 成功的统计学标准要求血清转化受试者比例的95% CI下限大于50%。1. 确定QHPV疫苗在&gt; 7至&lt; 12岁的HIV感染儿童中的安全性和耐受性。 2.确定&gt; 7至&lt; 12岁的HIV感染儿童接种QHPV疫苗后的血清转换。

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.