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Title: BCG vaccination in patients with severe combined immunodeficiency: Complications, risks, and vaccination policies
Authors: Marciano, Beatriz E.
Huang, Chiung-Yu
Joshi, Gyan
Rezaei, Nima
Costa-Carvalho, Beatriz Tavares [UNIFESP]
Allwood, Zoe
Ikinciogullari, Aydan
Reda, Shereen M.
Gennery, Andrew
Thon, Vojtech
Espinosa-Rosales, Francisco
Al-Herz, Waleed
Porras, Oscar
Shcherbina, Anna
Szaflarska, Anna
Kilic, Sebnem
Franco, Jose L.
Gomez Raccio, Andrea C.
Roxo, Persio
Esteves, Isabel
Galal, Nermeen
Grumach, Anete Sevciovic
Al-Tamemi, Salem
Yildiran, Alisan
Orellana, Julio C.
Yamada, Masafumi
Morio, Tomohiro
Liberatore, Diana
Ohtsuka, Yoshitoshi
Lau, Yu-Lung
Nishikomori, Ryuta
Torres-Lozano, Carlos
Mazzucchelli, Juliana T. L. [UNIFESP]
Vilela, Maria M. S. [UNIFESP]
Tavares, Fabiola S. [UNIFESP]
Cunha, Luciana
Pinto, Jorge A.
Espinosa-Padilla, Sara E.
Hernandez-Nieto, Leticia
Elfeky, Reem A.
Ariga, Tadashi
Toshio, Heike
Dogu, Figen
Cipe, Funda
Formankova, Renata
Enriqueta Nunez-Nunez, M.
Bezrodnik, Liliana
Marques, Jose Goncalo
Pereira, Maria I.
Listello, Viviana
Slatter, Mary A.
Nademi, Zohreh
Kowalczyk, Danuta
Fleisher, Thomas A.
Davies, Graham
Neven, Benedicte
Rosenzweig, Sergio D.
Univ Tehran Med Sci
Universidade Federal de São Paulo (UNIFESP)
Great Ormond St Hosp Sick Children
Ankara Univ
Ain Shams Univ
Great North Childrens Hosp
Masaryk Univ
Natl Inst Pediat
Kuwait Univ
Natl Childrens Hosp Dr Carlos Saenz Herrera
Ctr Pediat Hematol Oncol & Immunol
Childrens Univ Hosp
Uludag Univ
Univ Antioquia
Childrens Hosp Ricardo Gutierrez
Universidade de São Paulo (USP)
Hosp Santa Maria
Cairo Univ
Sultan Qaboos Univ Hosp
Ondokuz Mayis Univ
Santisima Trinidad Childrens Hosp
Hokkaido Univ
Tokyo Med & Dent Univ
Italian Hosp
Hyogo Coll Med
Univ Hong Kong
Kyoto Univ Hosp
Western Natl Med Ctr
Universidade Federal de Minas Gerais (UFMG)
Charles Univ Prague
Univ Hosp Motol
Hop Necker Enfants Malad
Keywords: Primary immunodeficiency
severe combined immunodeficiency
newborn screening
hematopoietic stem cell transplant
immune reconstitution syndrome
Issue Date: 1-Apr-2014
Publisher: Elsevier B.V.
Citation: Journal of Allergy and Clinical Immunology. New York: Mosby-Elsevier, v. 133, n. 4, p. 1134-1141, 2014.
Abstract: Background: Severe combined immunodeficiency (SCID) is a syndrome characterized by profound T-cell deficiency. BCG vaccine is contraindicated in patients with SCID. Because most countries encourage BCG vaccination at birth, a high percentage of patients with SCID are vaccinated before their immune defect is detected.Objectives: We sought to describe the complications and risks associated with BCG vaccination in patients with SCID.Methods: An extensive standardized questionnaire evaluating complications, therapeutics, and outcomes regarding BCG vaccination in patients given a diagnosis of SCID was widely distributed. Summary statistics and association analysis was performed.Results: Data on 349 BCG-vaccinated patients with SCID from 28 centers in 17 countries were analyzed. Fifty-one percent of the patients had BCG-associated complications, 34% disseminated and 17% localized (a 33,000- and 400-fold increase, respectively, over the general population). Patients receiving early vaccination (<= 3 1 month) showed an increased prevalence of complications (P = 5.006) and death caused by BCG-associated complications (P < .0001). the odds of experiencing complications among patients with T-cell numbers of 250/mu L or less at diagnosis was 2.1 times higher (95% CI, 1.4-3.4 times higher; P = .001) than among those with T-cell numbers of greater than 250/mL. BCG-associated complications were reported in 2 of 78 patients who received antimycobacterial therapy while asymptomatic, and no deaths caused by BCG-associated complications occurred in this group. in contrast, 46 BCG-associated deaths were reported among 160 patients treated with antimycobacterial therapy for a symptomatic BCG infection (P < .0001).Conclusions: BCG vaccine has a very high rate of complications in patients with SCID, which increase morbidity and mortality rates. Until safer and more efficient antituberculosis vaccines become available, delay in BCG vaccination should be considered to protect highly vulnerable populations from preventable complications.
ISSN: 0091-6749
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