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临床试验/NCT05435209
NCT05435209已完成4 期

A Longitudinal Cohort Study to Assess Effectiveness and B-memory Response to the Quadrivalent HPV Vaccine 9 Years Post-vaccination Among HIV-Infected Boys and Girls Ages 9-14 Years in Kenya

University of Washington1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2022年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
158
试验地点
1
主要终点
Persistent Genital HPV infection

研究概览

简要总结

The risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection.

Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection.

Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.

详细描述

Background: Genital Human Papilloma Virus (HPV) infections occur rapidly after sexual debut, and immunosuppressed individuals are at greater risk for incident and persistent infection. HPV vaccine contains virus-like particles (VLP), which are highly immunogenic and induce a robust humoral response that has been demonstrated to confer long term protection from HPV infection and associated disease among HIV-uninfected individuals. The magnitude of type-specific vaccine induced neutralizing HPV antibody responses are diminished among HIV-infected compared to uninfected individuals.

There is no established minimum level of antibody that predicts protection against HPV infection or associated disease, the impact of lower antibody titers among HIV infected individuals on vaccine efficacy is unknown. The risk of HPV exposure persists throughout a person's sexual life and the duration of protection, especially when the vaccine is given in the early adolescent period is critical to vaccine effectiveness. Long lasting memory is characterized by memory B cells and long-lived plasma cells and a QHPV booster dose has demonstrated an anamnestic response among HIV-infected adolescents.

HPV efficacy and effectiveness data for HIV-uninfected individuals has informed the current World Health Organization (WHO) two-dose vaccine schedule. The field lacks data on effectiveness of three dose or two-dose for the HIV-infected adolescents. The current on-going research for single dose schedules gives urgency to the determination of long-term efficacy of three HPV vaccine 231 doses for the HIV-infected adolescent.

Investigators shall recall HIV-infected girls and boys who were previously vaccinated at ages 9-14 years with three doses of the quadrivalent vaccine (QHPV) in 2014 and evaluated for vaccine immunogenicity.

Method: The participants will be assessed for genital warts and genital HPV infection. Type specific HPV DNA will be assessed using genital swabs and genital warts assessed through physical examination among sexually active participants at enrollment, month 6 &12.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HIV-infected
  • enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014

排除标准

  • Decline re-enrollment
  • unable to provide informed consent
  • minor without parent or guardian consent

研究组 & 干预措施

Quadrivalent HPV Vaccine

Experimental

Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh

干预措施: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine (Drug)

结局指标

主要结局

Persistent Genital HPV infection

时间窗: Nine years after primary vaccination

Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)

Sustained QHPV vaccine specific antibody titers

时间窗: Nine years after primary vaccination

Concentration of QHPV specific antibody titers (HPV -6, -11, -16 \& -18) nine years after primary vaccination

次要结局

  • Immune memory following three doses of QHPV(One month after booster vaccine)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelly Mugo

Associate Professor, School of Medicine: Global Health

University of Washington

研究点 (1)

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