NCT05351216

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 174 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Kaposiform Hemangioendothelioma

Interventions

Type	Name	Description
OTHER	—	No intervention

Timeline

• Start date: 2021-03-01
• Primary completion: 2026-03-01
• Completion: 2028-03-01
• First posted: 2022-04-28
• Last updated: 2025-06-27

Locations

1 site across 1 country: China