PMID- 33111199 OWN - NLM STAT- MEDLINE DCOM- 20220114 LR - 20220114 IS - 1573-2592 (Electronic) IS - 0271-9142 (Print) IS - 0271-9142 (Linking) VI - 41 IP - 1 DP - 2021 Jan TI - Bacillus Calmette-Guerin (BCG) Vaccine-associated Complications in Immunodeficient Patients Following Stem Cell Transplantation. PG - 147-162 LID - 10.1007/s10875-020-00892-6 [doi] AB - PURPOSE: Bacillus Calmette-Guerin (BCG) is a live attenuated vaccine with the potential of causing severe iatrogenic complications in patients with primary immunodeficiency diseases (PID) before and after hematopoietic stem cell transplantation (HSCT). We aim to investigate risk factors of post-HSCT BCG-related complications in PID patients. METHODS: A retrospective analysis of pediatric PID patients who had received the BCG vaccine and underwent HSCT at Hadassah-Hebrew University Medical Center, between 2007 and 2019. RESULTS: We found 15/36 (41.67%) patients who developed post-HSCT BCG-related complications. The most significant risk factor for developing BCG-related complications was T cell deficiency (47.6% of the non-complicated vs 83.3% of the BCGitis and 100% of the BCGosis groups had T cell lymphopenia, p = 0.013). None of the chronic granulomatous patients developed BCG-related manifestation post-transplant. Among T cell-deficient patients, lower NK (127 vs 698 cells/mul, p = 0.04) cell counts and NK-SCID were risk factors for ongoing post-HSCT BCGosis, as was pretransplant disseminated BCGosis (33.3% of patients with BCGosis vs none of the non-BCGosis patients, p = 0.04). Immune reconstitution inflammatory syndrome (IRIS) was observed in 3/5 patients with Omenn syndrome. Prophylactic antimycobacterial treatment was not proven effective. CONCLUSION: BCG vaccination can cause significant morbidity and mortality in the post-transplant T cell-deficient patient, especially in the presence of pre-transplant disease. Taking a detailed medical history prior to administering, the BCG vaccine is crucial for prevention of this complication. FAU - NaserEddin, Adeeb AU - NaserEddin A AD - Bone Marrow Transplantation Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. adeeb@hadassah.org.il. AD - Hadassah Medical Organization, POB 12000, Kiryat Hadassah, 91120, Jerusalem, Israel. adeeb@hadassah.org.il. FAU - Dinur-Schejter, Yael AU - Dinur-Schejter Y AUID- ORCID: 0000-0003-3332-2391 AD - Bone Marrow Transplantation Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. AD - Allergy & Clinical Immunology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Shadur, Bella AU - Shadur B AD - Garvan Institute of Medical Research, Sydney, Australia. AD - Graduate Research School, University of New South Wales, Kensington, Australia. FAU - Zaidman, Irina AU - Zaidman I AD - Bone Marrow Transplantation Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Even-Or, Ehud AU - Even-Or E AD - Bone Marrow Transplantation Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Averbuch, Diana AU - Averbuch D AD - Pediatric Infectious Diseases Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Shamriz, Oded AU - Shamriz O AD - Allergy & Clinical Immunology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Tal, Yuval AU - Tal Y AD - Allergy & Clinical Immunology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Shaag, Avraham AU - Shaag A AD - Monique and Jacques Roboh Department of Genetic Research, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Warnatz, Klaus AU - Warnatz K AD - Department for Rheumatology and Clinical Immunology and Center for Chronic Immunodeficiency (CCI), Medical Center, University of Freiburg, Faculty of Medicine, Freiburg im Breisgau, Germany. AD - Center for Chronic Immunodeficiency (CCI), Medical Center, University of Freiburg, Faculty of Medicine, Freiburg im Breisgau, Germany. FAU - Elpeleg, Orly AU - Elpeleg O AD - Monique and Jacques Roboh Department of Genetic Research, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. FAU - Stepensky, Polina AU - Stepensky P AD - Bone Marrow Transplantation Department, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201027 PL - Netherlands TA - J Clin Immunol JT - Journal of clinical immunology JID - 8102137 RN - 0 (BCG Vaccine) RN - 0 (Biomarkers) SB - IM MH - BCG Vaccine/*adverse effects/immunology MH - Biomarkers MH - Child, Preschool MH - Diagnosis, Differential MH - Disease Susceptibility MH - Female MH - Graft vs Host Disease/diagnosis/etiology MH - Hematopoietic Stem Cell Transplantation/*adverse effects/methods MH - Humans MH - *Immunocompromised Host MH - Infant MH - Infant, Newborn MH - Male MH - Patient Outcome Assessment MH - Primary Immunodeficiency Diseases/*complications/diagnosis/*immunology/therapy MH - Retrospective Studies MH - Vaccination/adverse effects PMC - PMC7591244 OTO - NOTNLM OT - BCG vaccination OT - hematopoietic stem cell transplantation OT - immune reconstitution inflammatory syndrome OT - primary immune deficiency OT - severe combined immunodeficiency COIS- The authors declare that they have no conflict of interest. EDAT- 2020/10/29 06:00 MHDA- 2022/01/15 06:00 PMCR- 2020/10/27 CRDT- 2020/10/28 05:43 PHST- 2020/06/25 00:00 [received] PHST- 2020/10/07 00:00 [accepted] PHST- 2020/10/29 06:00 [pubmed] PHST- 2022/01/15 06:00 [medline] PHST- 2020/10/28 05:43 [entrez] PHST- 2020/10/27 00:00 [pmc-release] AID - 10.1007/s10875-020-00892-6 [pii] AID - 892 [pii] AID - 10.1007/s10875-020-00892-6 [doi] PST - ppublish SO - J Clin Immunol. 2021 Jan;41(1):147-162. doi: 10.1007/s10875-020-00892-6. Epub 2020 Oct 27.