The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Outcome Measures
Primary Outcome Measures
- Titers of Hepatitis B virus surface antibody [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 [The 7th month after admission]
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
- Titers of Hepatitis B virus surface antibody [The 12th month after admission]
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
- Titers of Hepatitis B virus surface antibody [The 18th month after admission]
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Secondary Outcome Measures
- Levels of measles antibodies. [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of mumps antibodies [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of rubella antibodies. [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of measles antibodies. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of mumps antibodies. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of rubella antibodies. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of measles antibodies. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of mumps antibodies. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of rubella antibodies. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of measles antibodies. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of mumps antibodies. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Levels of rubella antibodies. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of Japanese encephalitis antibody. [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of Japanese encephalitis antibody. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of Japanese encephalitis antibody. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of Japanese encephalitis antibody. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of varicella antibody [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of varicella antibody. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of varicella antibody. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of varicella antibody. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of COVID-19 antibody. [Admission within 1 day]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of COVID-19 antibody. [The 7th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of COVID-19 antibody. [The 12th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
- Level of COVID-19 antibody. [The 18th month after admission]
This outcome indicates whether there is persistent protective antibodies after vaccination.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Case groups:
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KHE patients treated with sirolimus.
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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.
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Control groups:
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Healthy children with no immune deficiencies.
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Participants are vaccinated according to the National Immunization Program in a timely manner.
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Participants are matched to the case group according to age.
Exclusion Criteria:
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HBsAg, HBeAg positive, or other active infectious diseases;
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History of immunodeficiency or low immunoglobulin levels;
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Autoimmune disease or fever during blood collection;
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Use of other medication or surgery;
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Suffering from other bleeding disorders;
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Suffering from other solid tumors or hematological tumors, etc.;
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Withdraw informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Fudan University | Shanghai | Shanghai | China | 201102 |
Sponsors and Collaborators
- Children's Hospital of Fudan University
Investigators
- Principal Investigator: Kai Li, PhD, Children's Hospital of Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
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- LK220323