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

Kaposiform Hemangioendothelioma Clinical Trial

Official title:

The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351216
• Other study ID #: LK220323
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: Children's Hospital of Fudan University
• Contact: Kai Li, PhD
• Phone: 02164931114
• Email: likai2727[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: March 2028
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemangioendothelioma
• Kaposiform Hemangioendothelioma
• Kasabach-Merritt Syndrome
• Sarcoma, Kaposi

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (10)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Titers of Hepatitis B virus surface antibody	Titers of Hepatitis B virus surface antibody,indicating whether there is persistent	The 7th month after admission
Primary	Titers of Hepatitis B virus surface antibody	Titers of Hepatitis B virus surface antibody,indicating whether there is persistent	The 12th month after admission
Primary	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	Levels of measles antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Levels of mumps antibodies	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Levels of rubella antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Levels of measles antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Levels of mumps antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Levels of rubella antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Levels of measles antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Levels of mumps antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Levels of rubella antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Levels of measles antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission
Secondary	Levels of mumps antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission
Secondary	Levels of rubella antibodies.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission
Secondary	Level of Japanese encephalitis antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Level of Japanese encephalitis antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Level of Japanese encephalitis antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Level of Japanese encephalitis antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission
Secondary	Level of varicella antibody	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Level of varicella antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Level of varicella antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Level of varicella antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission
Secondary	Level of COVID-19 antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	Admission within 1 day
Secondary	Level of COVID-19 antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 7th month after admission
Secondary	Level of COVID-19 antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 12th month after admission
Secondary	Level of COVID-19 antibody.	This outcome indicates whether there is persistent protective antibodies after vaccination.	The 18th month after admission