A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Human Papillomavirus Antibody Titers
研究概览
简要总结
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
详细描述
We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.
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
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receipt of 3 doses of QHPV vaccine
- •participated in primary immunogenicity study
- •consent/assent with parental consent for participants age <18 years
- •willing to continue extended follow up for 36 months
排除标准
- •decline consent
结局指标
主要结局
Human Papillomavirus Antibody Titers
时间窗: 48 months
Geometric mean titers for HPV type -6, -11, -16 and -18
次要结局
- HIV RNA viral load(48 months)
- CD 4 cell count(48 months)
研究者
Nelly Rwamba Mugo
Senior Principal Clinical Research Scientist
Kenya Medical Research Institute