Exploring the effects of sirolimus on vaccinations in children with Kaposiform Hemangioendothelioma
Official title: The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
Run by Children's Hospital of Fudan University · NCT05351216 · Data updated 2026-11-12
This study is testing how the medication sirolimus affects the ability of children with Kaposiform Hemangioendothelioma to respond to vaccines and whether different vaccination methods might work better for them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 12 Years |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 1, 2021 |
| Main results expected | March 2026 |
| Study ends | March 2028 |
| Registry record updated | June 27, 2025 |
| Trial ID | NCT05351216 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children diagnosed with Kaposiform Hemangioendothelioma who are currently being treated with sirolimus.
✕Probably not a fit
Patients with active infectious diseases, autoimmune disorders, or those who have previously shown immunodeficiency may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how sirolimus treatment affects antibody protection and immune memory in children with Kaposiform Hemangioendothelioma (KHE) during vaccination. It aims to assess the safety and efficacy of administering vaccines while these children are on sirolimus, which is known to suppress the immune system. The research will also explore alternative vaccination strategies for KHE patients who do not respond to standard vaccination protocols. By evaluating both case and control groups, the study seeks to provide insights into the immunization needs of this vulnerable population.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies for children with KHE, ensuring they receive necessary immunizations despite immunosuppressive treatment.
How similar studies have gone: While there is limited data on this specific approach, similar studies have indicated challenges in vaccination efficacy among immunocompromised patients, suggesting this area requires further exploration.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Kai Li, PhD — Children's Hospital of Fudan University
- Study coordinator: Kai Li, PhD
- Email: likai2727@163.com
- Phone: 02164931114
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sirolimus Withdrawal Strategies for Kaposiform Hemangioendothelioma
This study tests how to safely stop sirolimus in people with Kaposiform Hemangioendothelioma to see if disease stays controlled after withdrawal.
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Identifying biomarkers for vascular anomalies
This study is trying to find simple blood tests that can help doctors better diagnose and treat patients with rare blood vessel problems like Generalized Lymphatic Anomaly and Gorham-Stout Disease.
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Registry for patients with lymphatic anomalies
This study is collecting information from people with lymphatic anomalies to see how these conditions affect their health and treatment over time.
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Low- vs High-Dose Sirolimus With Prednisolone for KHE/KMP in Children
This trial tests whether a lower dose of sirolimus with prednisolone works as well as a higher dose with prednisolone for kids with Kaposiform Hemangioendothelioma and Kasabach-Merritt phenomenon.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.