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.
Eligibility
Sex
ALL
Min age
—
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Titers of Hepatitis B virus surface antibody — Admission within 1 day Titers of Hepatitis B virus surface antibody，indicating whether there is persistent protective antibodies after vaccination.
Titers of Hepatitis B virus surface antibody — The 7th month after admission Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Titers of Hepatitis B virus surface antibody — The 12th month after admission Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Titers of Hepatitis B virus surface antibody — The 18th month after admission Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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