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BCG vaccination in patients with severe combined immunodeficiency: complications, risks, and vaccination policies. 2014
Beatriz E Marciano, and
Chiung-Yu Huang, and
Gyan Joshi, and
Nima Rezaei, and
Beatriz Costa Carvalho, and
Zoe Allwood, and
Aydan Ikinciogullari, and
Shereen M Reda, and
Andrew Gennery, and
Vojtech Thon, and
Francisco Espinosa-Rosales, and
Waleed Al-Herz, and
Oscar Porras, and
Anna Shcherbina, and
Anna Szaflarska, and
Şebnem Kiliç, and
Jose L Franco, and
Andrea C Gómez Raccio, and
Persio Roxo, and
Isabel Esteves, and
Nermeen Galal, and
Anete Sevciovic Grumach, and
Salem Al-Tamemi, and
Alisan Yildiran, and
Julio C Orellana, and
Masafumi Yamada, and
Tomohiro Morio, and
Diana Liberatore, and
Yoshitoshi Ohtsuka, and
Yu-Lung Lau, and
Ryuta Nishikomori, and
Carlos Torres-Lozano, and
Juliana T L Mazzucchelli, and
Maria M S Vilela, and
Fabiola S Tavares, and
Luciana Cunha, and
Jorge A Pinto, and
Sara E Espinosa-Padilla, and
Leticia Hernandez-Nieto, and
Reem A Elfeky, and
Tadashi Ariga, and
Heike Toshio, and
Figen Dogu, and
Funda Cipe, and
Renata Formankova, and
M Enriqueta Nuñez-Nuñez, and
Liliana Bezrodnik, and
Jose Gonçalo Marques, and
María I Pereira, and
Viviana Listello, and
Mary A Slatter, and
Zohreh Nademi, and
Danuta Kowalczyk, and
Thomas A Fleisher, and
Graham Davies, and
Bénédicte Neven, and
Sergio D Rosenzweig
Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
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. OBJECTIVE 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.
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