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 volunteersQualifiers
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
Case-control
Prospective
Treatments tested in this trial
- Other intervention
No intervention
Treatment groups
Trial outcomes
Primary outcomes
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody,indicating whether there is persistent protective antibodies after vaccination.
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody,indicating whether there is persistent
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody,indicating whether there is persistent
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody,indicating whether there is persistent
Secondary outcomes
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Levels of mumps antibodies
This outcome indicates whether there is persistent protective antibodies after vaccination.
Levels of rubella antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Sponsors and contacts
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