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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое
  No intervention

Первичные конечные точки

• Titers of Hepatitis B virus surface antibody [Срок оценки: Admission within 1 day]
• Titers of Hepatitis B virus surface antibody [Срок оценки: The 7th month after admission]
• Titers of Hepatitis B virus surface antibody [Срок оценки: The 12th month after admission]
• Titers of Hepatitis B virus surface antibody [Срок оценки: The 18th month after admission]

Вторичные конечные точки (12)

• Levels of measles antibodies. [Срок оценки: Admission within 1 day]
• Levels of mumps antibodies [Срок оценки: Admission within 1 day]
• Levels of rubella antibodies. [Срок оценки: Admission within 1 day]
• Levels of measles antibodies. [Срок оценки: The 7th month after admission]
• Levels of mumps antibodies. [Срок оценки: The 7th month after admission]
• Levels of rubella antibodies. [Срок оценки: The 7th month after admission]
• Levels of measles antibodies. [Срок оценки: The 12th month after admission]
• Levels of mumps antibodies. [Срок оценки: The 12th month after admission]
• Levels of rubella antibodies. [Срок оценки: The 12th month after admission]
• Levels of measles antibodies. [Срок оценки: The 18th month after admission]
• Levels of mumps antibodies. [Срок оценки: The 18th month after admission]
• Levels of rubella antibodies. [Срок оценки: The 18th month after admission]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Публикации

• 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. PMID 15274078
• 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
• 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
• 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
• 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
• 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 St PMID 30843046
• 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
• 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

Идентификаторы

NCT: NCT05351216 · LK220323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗