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

NCT05351216 | Recruiting

• 1 other identifier: LK220323
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Kaposiform Hemangioendothelioma

Keywords

Following National Vaccination Program; Sirolimus

Outcome Measures

Primary Outcomes (4)

• Titers of Hepatitis B virus surface antibody

  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

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

  The 7th month after admission

• Titers of Hepatitis B virus surface antibody

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

  The 12th month after admission

• Titers of Hepatitis B virus surface antibody

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

  The 18th month after admission

Secondary Outcomes (24)

• Levels of measles antibodies.

  Admission within 1 day

• Levels of mumps antibodies

  Admission within 1 day

• Levels of rubella antibodies.

  Admission within 1 day

• Levels of measles antibodies.

  The 7th month after admission

• Levels of mumps antibodies.

  The 7th month after admission

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (10)

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• 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.

  PMID: 22219618 BACKGROUND

• 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.

  PMID: 22760290 BACKGROUND

• 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.

  PMID: 25665961 BACKGROUND

• 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.

  PMID: 29664566 BACKGROUND

• 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.

  PMID: 30843046 BACKGROUND

• 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.

  PMID: 28886882 BACKGROUND

• 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.

  PMID: 31968262 BACKGROUND

• 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.

  PMID: 27925503 BACKGROUND

• 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.

  PMID: 32423345 BACKGROUND

MeSH Terms

Conditions

Kaposiform Hemangioendothelioma

Study Officials

• Kai Li, PhD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Li, PhD

CONTACT

02164931114; likai2727@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 28, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)