The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma

June 24, 2025 updated by: Children's Hospital of Fudan University

The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:
          • Kai Li, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The calculation of the sample size came from the previous pre-experiment. Investigator take HBsAb protection rate as the main outcome indicator. The sample size of this study, calculated using a non-inferiority test, was 156 (78 per group). In addition, 10% was required to make up for loss to follow-up, withdrawal, etc. So a total of 174 subjects (87 per group) are anticipated.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cases
Individuals diagnosed with KHE and 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. （Sirolimus Rapamycin 0.8mg/m2 bid po）
Controls
Healthy children with no immunodeficiency disease, vaccinated according to the National Immunization Program. Particpants should be age-matched with the case group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Admission within 1 day
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
The 7th month after admission
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
The 12th month after admission
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
The 18th month after admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Levels of measles antibodies.
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Levels of mumps antibodies
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Levels of rubella antibodies.
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Levels of measles antibodies.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Levels of mumps antibodies.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Levels of rubella antibodies.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Levels of measles antibodies.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Levels of mumps antibodies.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Levels of rubella antibodies.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Levels of measles antibodies.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission
Levels of mumps antibodies.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission
Levels of rubella antibodies.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission
Level of Japanese encephalitis antibody.
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Level of Japanese encephalitis antibody.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Level of Japanese encephalitis antibody.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Level of Japanese encephalitis antibody.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission
Level of varicella antibody
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Level of varicella antibody.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Level of varicella antibody.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Level of varicella antibody.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission
Level of COVID-19 antibody.
Time Frame: Admission within 1 day
This outcome indicates whether there is persistent protective antibodies after vaccination.
Admission within 1 day
Level of COVID-19 antibody.
Time Frame: The 7th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 7th month after admission
Level of COVID-19 antibody.
Time Frame: The 12th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 12th month after admission
Level of COVID-19 antibody.
Time Frame: The 18th month after admission
This outcome indicates whether there is persistent protective antibodies after vaccination.
The 18th month after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kai Li, PhD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LK220323

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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