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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 12
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Kai Li, PhD
likai2727@163.com
02164931114
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 174
Treatments
Cases
Individuals diagnosed with KHE and 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. (Sirolimus Rapamycin 0.8mg/m2 bid po)
Controls
Healthy children with no immunodeficiency disease, vaccinated according to the National Immunization Program. Particpants should be age-matched with the case group.
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov

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