BCG adverse events: clinical outcome and rate of associated immunodeficiency

• Grant number: 11/21754-8
• Support Opportunities: Regular Research Grants
• Start date: April 01, 2012
• End date: September 30, 2014
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Maria Isabel de Moraes Pinto
• Grantee: Maria Isabel de Moraes Pinto
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• City of the host institution: São Paulo
• Associated researchers: Anete Sevciovic Grumach ; Antonio Condino Neto ; Beatriz Tavares Costa Carvalho ; Lily Yin Weckx ; Thais das Neves Fraga Moreira

Abstract

BCG vaccine is a major strategy of WHO for the control of mortality by severe forms of tuberculosis. Although adverse events after the vaccine are considered rare, the dissemination of M. bovis is potentially fatal and occurs almost exclusively in immunodeficient individuals. The relationship between localized adverse event and immunodeficiency is not well established in the literature. It is believed that localized events occur mostly due to a wrong application technique or high reactogenicity of BCG strain used. However, it is possible that some of these events are the initial manifestation of an undiagnosed immunodeficiency. This study aims to evaluate clinical aspects and immunological responses of patients with adverse events after BCG. We propose a follow-up prospective study of patients reported in São Paulo with BCG adverse events from 2011 to 2013. The clinical data of patients will be collected and treatment will be established according to the type of event and in agreement with the Brazilian Ministry of Health guidelines. Patients with localized events who need specific drug treatment or those who present with BCG dissemination will be evaluated immunologically. The laboratorial investigation will consist of: complete blood count, HIV testing, evaluation of chronic granulomatous disease by testing dihydro-rhodamine (DHR), investigation of severe combined immunodeficiency (SCID) by evaluating the phenotypic profile of lymphocytes and assessment of IFN³-IL12/IL-23 defects. The data will be analyzed in order to determine the population characteristics and BCG adverse events, the clinical outcomes of patients with the treatment proposed by the Ministry of Health, the rate of immunodeficiency and the correlation between clinical data and risk of immunodeficiency. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

FRAGA MOREIRA, THAIS DAS NEVES; DE MORAES-PINTO, MARIA ISABEL; COSTA-CARVALHO, BEATRIZ TAVARES; GRUMACH, ANETE SEVCIOVIC; WECKX, LILY YIN. CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN. Revista do Instituto de Medicina Tropical de São Paulo, v. 58, 2016. (11/21754-8)