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临床试验/NCT04920526
NCT04920526Unknown不适用

Effectiveness of the QHPV Among Kenyan HIV Infected Girls and Boys 9 Years Post Vaccination

Kenya Medical Research Institute0 个研究点目标入组 135 人开始时间: 2021年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
135
主要终点
B-memory cell elicitation in the participants given a booster vaccine

研究概览

简要总结

In 2013, the Investigators enrolled a cohort of 180 HIV-1 infected adolescent girls and boys ages 9-14 years and administered three doses of the QHPV vaccine (NCT04711265). For this study, the Investigators shall evaluate vaccine effectiveness 9 years post first vaccination.

Participants will be evaluated for HPV type specific antibody, genital HPV infection, genital warts and a subset of 30 participants will be evaluated for memory B and T cell responses.

详细描述

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 participles (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 doses for the HIV-infected adolescent.

The 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • received three doses of the quadrivalent HPV vaccine and enrolled in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
  • participant consent or parental/guardian consent and participant assent for participants still <18 years of age
  • participants and guardians who consented to be contacted for further evaluation and participation in research and
  • are willing to continue longer-term follow up.

排除标准

  • Did not participate in the quadrivalent HPV vaccine safety and immunogenicity study (MISP 38406)
  • Not willing or able to provide written informed consent/assent to participate in the study

研究组 & 干预措施

QHPV Vaccine

all participants have received QHPV

干预措施: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine (Drug)

结局指标

主要结局

B-memory cell elicitation in the participants given a booster vaccine

时间窗: This will be measured at 12 months after receiving a booster vaccine

Elicited from Peripheral Blood Mononuclear Cell (PBMC)

Changes in persistent Genital HPV infection

时间窗: The changes will be measured at baseline (enrolment), month 6 and 12

Type specific HPV serotype: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes 31,33,35,39,45,51,52,56,58,59,66, 68,73 as per International Agency for Research on Cancer (IARC) monographs.

Changes in geometric titers for HPV-specific Antibodies

时间窗: This outcome will be measured at Month 12

Vaccine type specific HPV antibody Geometric Mean Titers: HPV- 6, 11, 16 \& 18

次要结局

未报告次要终点

研究者

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

Nelly Rwamba Mugo

Principal Investigator

Kenya Medical Research Institute

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