The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Titers of Hepatitis B virus surface antibody
研究概览
简要总结
To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccination in a timely manner during the administration of sirolimus in children with KHE. To search for back-up plans for vaccination regimens for KHE patients taking sirolimus in children who do not respond to primary vaccination.
详细描述
Children with KHE have an early onset. KHE usually occurs in infants and young children less than 1 year old, of which neonates account for about 38.5%-60% of all cases. Due to the immunosuppressive effect of sirolimus, the vaccination was usually suspended after taking it, and children would be in a state of no immune protection. These children are at greatly increased risk of exposure to microorganisms and consequent infection. Therefore, it is necessary to vaccinate them against infectious diseases. However, vaccination with live vaccines has the potential to cause severe infections through reversion of the vaccine strain to a pathogenic form. Moreover, studies have also shown that protective antibodies are severely affected in transplant patients taking immunosuppressive drugs and in patients with solid tumors after chemotherapy. Loss of immune memory is very common, and marked deficits in B cell function and humoral immunity can persist even for years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Case groups:
- •KHE patients treated with sirolimus.
- •After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice.
- •Control groups:
- •Healthy children with no immune deficiencies.
- •Participants are vaccinated according to the National Immunization Program in a timely manner.
- •Participants are matched to the case group according to age.
排除标准
- •HBsAg, HBeAg positive, or other active infectious diseases;
- •History of immunodeficiency or low immunoglobulin levels;
- •Autoimmune disease or fever during blood collection;
- •Use of other medication or surgery;
- •Suffering from other bleeding disorders;
- •Suffering from other solid tumors or hematological tumors, etc.;
- •Withdraw informed consent.
结局指标
主要结局
Titers of Hepatitis B virus surface antibody
时间窗: The 18th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
次要结局
- Levels of rubella antibodies.(The 18th month after admission)
- Level of varicella antibody.(The 18th month after admission)
- Levels of measles antibodies.(The 18th month after admission)
- Levels of mumps antibodies(Admission within 1 day)
- Levels of mumps antibodies.(The 18th month after admission)
- Level of Japanese encephalitis antibody.(The 18th month after admission)
- Level of varicella antibody(Admission within 1 day)
- Level of COVID-19 antibody.(The 18th month after admission)