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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorChildren's Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Healthy children with no immune deficiencies.

Participants are vaccinated according to the National Immunization Program in a timely manner.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Other intervention

    No intervention

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: Cases0 interventions
Group B: Controls0 interventions

Trial outcomes

Primary outcomes

1

Titers of Hepatitis B virus surface antibody

Titers of Hepatitis B virus surface antibody,indicating whether there is persistent protective antibodies after vaccination.

Time frame
Admission within 1 day
2

Titers of Hepatitis B virus surface antibody

Titers of Hepatitis B virus surface antibody,indicating whether there is persistent

Time frame
The 7th month after admission
3

Titers of Hepatitis B virus surface antibody

Titers of Hepatitis B virus surface antibody,indicating whether there is persistent

Time frame
The 12th month after admission
4

Titers of Hepatitis B virus surface antibody

Titers of Hepatitis B virus surface antibody,indicating whether there is persistent

Time frame
The 18th month after admission

Secondary outcomes

1

Levels of measles antibodies.

This outcome indicates whether there is persistent protective antibodies after vaccination.

Time frame
Admission within 1 day
2

Levels of mumps antibodies

This outcome indicates whether there is persistent protective antibodies after vaccination.

Time frame
Admission within 1 day
3

Levels of rubella antibodies.

This outcome indicates whether there is persistent protective antibodies after vaccination.

Time frame
Admission within 1 day
4

Levels of measles antibodies.

This outcome indicates whether there is persistent protective antibodies after vaccination.

Time frame
The 7th month after admission

Other outcomes

Sponsors and contacts

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