Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Location status: Recruiting
Location contact
Kai Li, Doctor
CONTACT
Recruiting
NCT Number: NCT05351216
The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 12 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Titers of Hepatitis B virus surface antibody
Time frame: Admission within 1 day
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent protective antibodies after vaccination.
-
Titers of Hepatitis B virus surface antibody
Time frame: The 7th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
-
Titers of Hepatitis B virus surface antibody
Time frame: The 12th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
-
Titers of Hepatitis B virus surface antibody
Time frame: The 18th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Secondary outcomes
-
Levels of measles antibodies.
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of mumps antibodies
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of rubella antibodies.
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of measles antibodies.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of mumps antibodies.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of rubella antibodies.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of measles antibodies.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of mumps antibodies.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of rubella antibodies.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of measles antibodies.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of mumps antibodies.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Levels of rubella antibodies.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of Japanese encephalitis antibody.
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of Japanese encephalitis antibody.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of Japanese encephalitis antibody.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of Japanese encephalitis antibody.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of varicella antibody
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of varicella antibody.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of varicella antibody.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of varicella antibody.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of COVID-19 antibody.
Time frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of COVID-19 antibody.
Time frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of COVID-19 antibody.
Time frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
-
Level of COVID-19 antibody.
Time frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Children's Hospital of Fudan University
Other
Registry information
Official study title
The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
Important dates
- Study start
- 2021
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- Apr 28, 2022
- Registry last updated
- Jun 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
Identification of Biomarkers for Patients with Vascular Anomalies
NCT03001180
Angiomatosis, Bone Diseases
Boston, Massachusetts, United States
View Trial Details
Not Yet Recruiting
Sirolimus Discontinuation Strategies in Kaposiform Hemangioendothelioma
NCT07131644
Kaposiform Hemangioendothelioma
Chengdu, Sichuan, China
View Trial Details
Completed
Efficacy and Safety of Different Concentrations of Sirolimus in the Treatment of Kaposiform Hemangioendothelioma.
NCT04775173
Kaposiform Hemangioendothelioma
Chengdu, Sichuan, China
View Trial Details
Completed
Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma
NCT04448873
Blood Platelet Disorders, Cytopenia
Shanghai, Shanghai Municipality, China
View Trial Details