The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
NCT ID: NCT05351216
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
174 participants
OBSERVATIONAL
2021-03-01
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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）
No intervention
Controls
Healthy children with no immunodeficiency disease, vaccinated according to the National Immunization Program. Particpants should be age-matched with the case group.
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
Yes
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Kai Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Kai Li, Doctor
Role: primary
References
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Zignol M, Peracchi M, Tridello G, Pillon M, Fregonese F, D'Elia R, Zanesco L, Cesaro S. Assessment of humoral immunity to poliomyelitis, tetanus, hepatitis B, measles, rubella, and mumps in children after chemotherapy. Cancer. 2004 Aug 1;101(3):635-41. doi: 10.1002/cncr.20384.
Kwon HJ, Lee JW, Chung NG, Cho B, Kim HK, Kang JH. Assessment of serologic immunity to diphtheria-tetanus-pertussis after treatment of Korean pediatric hematology and oncology patients. J Korean Med Sci. 2012 Jan;27(1):78-83. doi: 10.3346/jkms.2012.27.1.78. Epub 2011 Dec 19.
Zhang J, Xie F, Delzell E, Chen L, Winthrop KL, Lewis JD, Saag KG, Baddley JW, Curtis JR. Association between vaccination for herpes zoster and risk of herpes zoster infection among older patients with selected immune-mediated diseases. JAMA. 2012 Jul 4;308(1):43-9. doi: 10.1001/jama.2012.7304.
Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine. 2015 Mar 17;33(12):1440-5. doi: 10.1016/j.vaccine.2015.01.075. Epub 2015 Feb 7.
Inoue T, Moran I, Shinnakasu R, Phan TG, Kurosaki T. Generation of memory B cells and their reactivation. Immunol Rev. 2018 May;283(1):138-149. doi: 10.1111/imr.12640.
Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernandez Rodriguez AM, Rebollo Rodrigo H, Campins Marti M, Perez R, Gonzalez Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers L, Aguera Morales ML, Rodriguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Z-041 Study Group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177.
Saghafian-Hedengren S, Soderstrom I, Sverremark-Ekstrom E, Nilsson A. Insights into defective serological memory after acute lymphoblastic leukaemia treatment: The role of the plasma cell survival niche, memory B-cells and gut microbiota in vaccine responses. Blood Rev. 2018 Jan;32(1):71-80. doi: 10.1016/j.blre.2017.08.009. Epub 2017 Aug 26.
Horns F, Dekker CL, Quake SR. Memory B Cell Activation, Broad Anti-influenza Antibodies, and Bystander Activation Revealed by Single-Cell Transcriptomics. Cell Rep. 2020 Jan 21;30(3):905-913.e6. doi: 10.1016/j.celrep.2019.12.063.
Dini G, Toletone A, Barberis I, Debarbieri N, Massa E, Paganino C, Bersi F, Montecucco A, Alicino C, Durando P. Persistence of protective anti-HBs antibody levels and anamnestic response to HBV booster vaccination: A cross-sectional study among healthcare students 20 years following the universal immunization campaign in Italy. Hum Vaccin Immunother. 2017 Feb;13(2):440-444. doi: 10.1080/21645515.2017.1264788.
Zhang L, Thornton CP, Ruble K, Cooper SL. Post-Chemotherapy Titer Status and Need for Revaccination After Treatment for Childhood Cancer. Clin Pediatr (Phila). 2020 Jun;59(6):606-613. doi: 10.1177/0009922820915884.
Other Identifiers
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LK220323
Identifier Type: -
Identifier Source: org_study_id
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