RecruitingNCT05351216

The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma

The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study


Sponsor

Children's Hospital of Fudan University

Enrollment

174 participants

Start Date

Mar 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Max Age: 12 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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.

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Interventions

OTHER

No intervention


Locations(1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT05351216


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