Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
研究概览
简要总结
Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients.
Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children or adolescents 9 to <18 years of age
- •Willing to sign consent/assent form
- •If HIV positive, under ART and undetectable viral load and CD4 cell count >200/mm3 (at least 6 months)
- •If the patient has received chemotherapy or is a SOT/HSCT recipient, referred for immunizations after adequate immune reconstitution according to routine clinical practice
排除标准
- •Previous history of warts and/or anal cancer.
- •Previous immunization with any HPV vaccine.
- •Age below
- •Patients who for any reason should not be included in the study according to the evaluation of the research team.
结局指标
主要结局
Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
时间窗: From baseline to month 18
Percentage of subjects maintaining antibody titers 18 months after immunization.
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
时间窗: From baseline to month 7
Percentage of subjects seroconverting from baseline to month 7
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
时间窗: From baseline to month 12
Percentage of subjects maintaining antibody titers 12 months after immunization.
次要结局
- Ratio of geometric mean serum antibody titers (GMTs)(From baseline to month 7)
- Delta of geometric mean serum antibody titers(From 1 to 12 months)
- Percentage of subjects seroconverting from baseline to month 7(From baseline to month 7)
研究者
Talia Sainz Costa
Principal Investigator
Instituto de Investigación Hospital Universitario La Paz