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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05351216
Study type Observational
Source Children's Hospital of Fudan University
Contact Kai Li, PhD
Phone 02164931114
Email likai2727@163.com
Status Recruiting
Phase
Start date March 1, 2021
Completion date March 2028

See also
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Completed NCT04775173 - Efficacy and Safety of Different Concentrations of Sirolimus in the Treatment of Kaposiform Hemangioendothelioma. Phase 2
Recruiting NCT03001180 - Identification of Biomarkers for Patients With Vascular Anomalies