Exploring the effects of sirolimus on vaccinations in children with Kaposiform Hemangioendothelioma
The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
Children's Hospital of Fudan University · NCT05351216
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 |
|---|---|
| Enrollment | 174 (estimated) |
| Ages | N/A to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05351216 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with Kaposiform Hemangioendothelioma who are currently being treated with sirolimus.
Not a fit: Patients with active infectious diseases, autoimmune disorders, or those who have previously shown immunodeficiency may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kaposiform Hemangioendothelioma, Following National Vaccination Program, Sirolimus