此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Preparedness Study - HPV Vaccine

2015年1月21日 更新者：H. Lee Moffitt Cancer Center and Research Institute

Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection

Moffitt Cancer Center is the Coordinating Center for this study.

The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.

The specific aims of this study are to:

  1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 [Gardasil]) or placebo vaccine.
  2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
  3. Assess the rate of compliance through the 3-dose vaccination series

研究概览

地位

完全的

条件

干预/治疗

详细说明

The study vaccine will be blindly administered as supplied on Day 1, Month 2, and Month 6. Both HPV and placebo vaccines will be in identical bottles, and all treatment codes will be kept under lock and key. All vaccines will be injected intramuscularly into the deltoid muscle by a member of the clinical staff. Each participant will be monitored for systemic and local reactions for 30 minutes postvaccination after each study vaccination for any adverse effects, including allergic reactions. Vaccine adverse events will continue to be monitored throughout the duration of the study period. Vaccine will be shipped to a central pharmacy at Stellenbosch University and stored in a refrigerator monitored and maintained at 2-8 C prior to distribution and local storage at participating clinical centers.

研究类型

介入性

注册 (实际的)

406

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 南非
      • Parow、南非、7505
        • Stellenbosch University
  • 美国
    • Florida
      • Tampa、Florida、美国、33612
        • H. Lee Moffitt Cancer Center and Research Institute

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 24年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
  • HIV negative
  • has ever had vaginal intercourse
  • has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
  • fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
  • agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
  • agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
  • agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
  • Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.

Exclusion Criteria:

  • have a history of severe allergic reaction
  • have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
  • are currently immuno-compromised
  • have received a marketed HPV vaccine, or are pregnant and lactating

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Gardasil Vaccine Administration
Gardasil Vaccine Administration. Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant could not be assigned more than 1 allocation number.
生物：Gardasil Vaccine
The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
其他名称：
  • 加德西
安慰剂比较：Placebo Administration
Placebo Administration. Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit. A single participant could not be assigned more than 1 allocation number.
其他：Placebo
The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Human Papillomavirus (HPV) Rate
大体时间：At Enrollment - 5 Month Enrollment Period
HPV type distribution and prevalence of each HPV type at enrollment.
At Enrollment - 5 Month Enrollment Period

次要结果测量

结果测量
措施说明
大体时间
Study Compliance Rate
大体时间：18 Months
Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
18 Months
Percentage of Participants Who Were Seropositive by HPV Type
大体时间：At Enrollment - 5 Month Enrollment Period
Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
At Enrollment - 5 Month Enrollment Period
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
大体时间：18 Months
Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
18 Months
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
大体时间：18 Months
The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.
18 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

H. Lee Moffitt Cancer Center and Research Institute

合作者

Merck Sharp & Dohme LLC

调查人员

  • 首席研究员：Anna Giuliano, Ph.D.、H. Lee Moffitt Cancer Center and Research Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年9月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2011年12月8日

首先提交符合 QC 标准的

2011年12月8日

首次发布 (估计)

2011年12月9日

研究记录更新

最后更新发布 (估计)

2015年2月6日

上次提交的符合 QC 标准的更新

2015年1月21日

最后验证

2015年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MCC-16685
  • IISP ID 39582 (其他赠款/资助编号：Merck)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Gardasil Vaccine的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Equatorial Guinea

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅