BCG vaccination in patients with severe combined immunodeficiency: Complications, risks, and vaccination policies


Por: Marciano B.E., Huang C.-Y., Joshi G., Rezaei N., Carvalho B.C., Allwood Z., Ikinciogullari A., Reda S.M., Gennery A., Thon V., Espinosa-Rosales F., Al-Herz W., Porras O., Shcherbina A., Szaflarska A., Kiliç S., Franco J.L., Gómez Raccio A.C., Roxo Jr. P., Esteves I., Galal N., Grumach A.S., Al-Tamemi S., Yildiran A., Orellana J.C., Yamada M., Morio T., Liberatore D., Ohtsuka Y., Lau Y.-L., Nishikomori R., Torres-Lozano C., Mazzucchelli J.T.L., Vilela M.M.S., Tavares F.S., Cunha L., Pinto J.A., Espinosa-Padilla S.E., Hernandez-Nieto L., Elfeky R.A., Ariga T., Toshio H., Dogu F., Cipe F., Formankova R., Nuñez-Nuñez M.E., Bezrodnik L., Marques J.G., Pereira M.I., Listello V., Slatter M.A., Nademi Z., Kowalczyk D., Fleisher T.A., Davies G., Neven B., Rosenzweig S.D.

Publicada: 1 ene 2014
Resumen:
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 (=1 month) showed an increased prevalence of complications (P =.006) and death caused by BCG-associated complications (P <.0001). The odds of experiencing complications among patients with T-cell numbers of 250/µL 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/µL. 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. © 2013 American Academy of Allergy, Asthma & Immunology.

Filiaciones:
Marciano B.E.:
 Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States

Huang C.-Y.:
 Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States

Joshi G.:
 Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States

Rezaei N.:
 Pediatric Center of Excellence, Children's Medical Center Hospital, Tehran University of Medical Sciences, Tehran, Iran

Carvalho B.C.:
 Department of Pediatrics, Federal University of São Paulo, São Paulo, Brazil

Allwood Z.:
 Immunology Department, Great Ormond Street Hospital for Children, London, United Kingdom

Ikinciogullari A.:
 Department of Pediatric Immunology and Allergy, Ankara University Medical School, Ankara, Turkey

Reda S.M.:
 Department of Pediatric Allergy and Immunology, Children's Hospital, Ain Shams University, Cairo, Egypt

Gennery A.:
 Paediatric Immunology Department, Great North Children's Hospital, Newcastle upon Tyne, United Kingdom

Thon V.:
 Department of Clinical Immunology and Allergy, Medical Faculty of Masaryk University, St Anne's University Hospital, Brno, Czech Republic

Espinosa-Rosales F.:
 National Institute of Pediatrics, Mexico City Federal District, Mexico City, Mexico

Al-Herz W.:
 Department of Pediatrics, Kuwait University, Al-Sabah Hospital, Kuwait City, Kuwait

Porras O.:
 Department of Immunology and Rheumatology, National Children's Hospital dr. Carlos Sáenz Herrera, San Jose, Costa Rica

Shcherbina A.:
 Department of Clinical Immunology, Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russian Federation

Szaflarska A.:
 Department of Clinical Immunology and Transplantology, Children's University Hospital, Krakow, Poland

Kiliç S.:
 Pediatric Immunology Division, Uludag University Medical Faculty, Bursa, Turkey

Franco J.L.:
 Primary Immunodeficiency Group, University of Antioquia, Medellin, Colombia

Gómez Raccio A.C.:
 Immunology Unit, Children's Hospital Ricardo Gutierrez, Buenos Aires, Argentina

Roxo Jr. P.:
 Faculty of Medicine of Ribeirão Preto, University of São Paulo, São Paulo, Brazil

Esteves I.:
 Primary Immunodeficiency Center, Lisbon Academic Center, Santa María Hospital, Lisbon, Portugal

Galal N.:
 Cairo University, Cairo, Egypt

Grumach A.S.:
 Faculty of Medicine of ABC, Santo André, São Paulo, Brazil

Al-Tamemi S.:
 Department of Child Health, Sultan Qaboos University Hospital, Muscat, Oman

Yildiran A.:
 Department of Pediatric Immunology-Allergy, Ondokuz Mayis University, Atakum-Samsun, Turkey

Orellana J.C.:
 Division of Allergy and Clinical Immunology, Santísima Trinidad Children's Hospital, Córdoba, Argentina

Yamada M.:
 Department of Pediatrics, Hokkaido University Graduate School of Medicine, Sapporo, Japan

Morio T.:
 Tokyo Medical and Dental University, Tokyo, Japan

Liberatore D.:
 Pediatric Immunology, Italian Hospital, Buenos Aires, Argentina

Ohtsuka Y.:
 Hyogo College of Medicine, Hyogo, Japan

Lau Y.-L.:
 Department of Pediatrics and Adolescent Medicine, LKS Faculty of Medicine, University of Hong Kong, Hong Kong, Hong Kong

Nishikomori R.:
 Department of Pediatrics, Kyoto University Hospital, Kyoto, Japan

Torres-Lozano C.:
 Department of Clinical Immunology and Allergology, Western National Medical Center, Guadalajara, Mexico

Mazzucchelli J.T.L.:
 Department of Pediatrics, Federal University of São Paulo, São Paulo, Brazil

Vilela M.M.S.:
 Department of Pediatrics, Federal University of São Paulo, São Paulo, Brazil

Tavares F.S.:
 Department of Pediatrics, Federal University of São Paulo, São Paulo, Brazil

Cunha L.:
 Federal University of Minas Gerais, Minas Gerais, Brazil

Pinto J.A.:
 Federal University of Minas Gerais, Minas Gerais, Brazil

Espinosa-Padilla S.E.:
 National Institute of Pediatrics, Mexico City Federal District, Mexico City, Mexico

Hernandez-Nieto L.:
 National Institute of Pediatrics, Mexico City Federal District, Mexico City, Mexico

Elfeky R.A.:
 Department of Pediatric Allergy and Immunology, Children's Hospital, Ain Shams University, Cairo, Egypt

Ariga T.:
 Department of Pediatrics, Hokkaido University Graduate School of Medicine, Sapporo, Japan

Toshio H.:
 Department of Pediatrics, Kyoto University Hospital, Kyoto, Japan

Dogu F.:
 Department of Pediatric Immunology and Allergy, Ankara University Medical School, Ankara, Turkey

Cipe F.:
 Department of Pediatric Immunology and Allergy, Ankara University Medical School, Ankara, Turkey

Formankova R.:
 Charles University, University Hospital Motol, Prague, Czech Republic

Nuñez-Nuñez M.E.:
 Department of Clinical Immunology and Allergology, Western National Medical Center, Guadalajara, Mexico

Bezrodnik L.:
 Immunology Unit, Children's Hospital Ricardo Gutierrez, Buenos Aires, Argentina

Marques J.G.:
 Primary Immunodeficiency Center, Lisbon Academic Center, Santa María Hospital, Lisbon, Portugal

Pereira M.I.:
 Division of Allergy and Clinical Immunology, Santísima Trinidad Children's Hospital, Córdoba, Argentina

Listello V.:
 Division of Allergy and Clinical Immunology, Santísima Trinidad Children's Hospital, Córdoba, Argentina

Slatter M.A.:
 Paediatric Immunology Department, Great North Children's Hospital, Newcastle upon Tyne, United Kingdom

Nademi Z.:
 Paediatric Immunology Department, Great North Children's Hospital, Newcastle upon Tyne, United Kingdom

Kowalczyk D.:
 Department of Clinical Immunology and Transplantology, Children's University Hospital, Krakow, Poland

Fleisher T.A.:
 Immunology Service, DLM, National Institutes of Health, Bethesda, MD, United States

Davies G.:
 Immunology Department, Great Ormond Street Hospital for Children, London, United Kingdom

Neven B.:
 Immunology-Hematology and Rheumatology Service, Necker Hospital, Paris, France

Rosenzweig S.D.:
 Primary Immunodeficiency Clinic and Infectious Diseases Susceptibility Unit, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States
ISSN: 00916749
Editorial
Mosby Inc., 360 PARK AVENUE SOUTH, NEW YORK, NY 10010-1710 USA, Estados Unidos America
Tipo de documento: Article
Volumen: 133 Número: 4
Páginas: 1134-1141
WOS Id: 000333531700025
ID de PubMed: 24679470
imagen All Open Access, Bronze

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