Complications of BCG vaccine SSI® recent story and risk management plan: the French experience.

Pharmacoepidemiol Drug Saf. 2012 Dec 5;

Authors: Chol C, Guy C, Jacquet A, Castot-Villepelet A, Kreft-Jais C, Cambazard F, Beyens MN, Mounier G, Marsille F, Mismetti P

Abstract
INTRODUCTION: As of January 2006, the BCG vaccine SSI® became the only BCG vaccine available for tuberculosis vaccination in France. The use of this vaccine led to significant changes in vaccination technique which were accompanied by a rapid increase in the number of adverse reactions (ADRs) reported. A national pharmacovigilance follow-up began in February 2006, and a risk management plan (RMP) was put in place in April 2006, made of three phases (carried out in June 2006, July 2006 and September 2006) with risk minimisation measures. The goal of this study was to evaluate the impact of the RMP on the amount of ADRs reported. METHODS: Based on data collected by the regional pharmacovigilance centres and the MSD laboratory, the cases of locoregional ADRs spontaneously reported were analysed retrospectively from January 2005 to February 2006, and then prospectively up to June 2008, the date at which the national follow-up ended. The locoregional ADRs were divided into three categories: abscesses, local reactions or lymphadenopathy of more than 1 cm and suppurative lymphadenopathy. A parallel was then drawn between these data and the different phases of the RMP. RESULTS: During the entire follow-up period, we note 1050 locoregional ADRs, of which 764 were abscesses (73% of all cases), 266 were local reactions and 20 involved suppurative lymphadenopathy.Locoregional ADRs increased rapidly from January 2006 onward, reaching a peak in August 006 and then falling and stabilising from December 2007 onward.The RMP was implemented when there was an increase in the number of ADRs reported. The drop in the number of these effects began 3 months after the first phase and 2 months after the second phase of the RMP. The third phase was not accompanied by a variation in the number of ADRs reported. CONCLUSION: The RMP appears to have positive effect on the evolution of the number of ADRs, their decrease occurring rapidly after the risk minimisation measures of the first two phases. Nonetheless, these data should be confirmed by other studies on the efficacy of RMPs. Copyright © 2012 John Wiley & Sons, Ltd.

PMID: 23213021 [PubMed - as supplied by publisher]

Roles of Mucosal Immunity against Mycobacterium tuberculosis Infection.

Tuberc Res Treat. 2012;2012:791728

Authors: Li W, Deng G, Li M, Liu X, Wang Y

Abstract
Mycobacterium tuberculosis (Mtb), the causative agent of tuberculosis (TB), is one of the world's leading infectious causes of morbidity and mortality. As a mucosal-transmitted pathogen, Mtb infects humans and animals mainly through the mucosal tissue of the respiratory tract. Apart from providing a physical barrier against the invasion of pathogen, the major function of the respiratory mucosa may be to serve as the inductive sites to initiate mucosal immune responses and sequentially provide the first line of defense for the host to defend against this pathogen. A large body of studies in the animals and humans have demonstrated that the mucosal immune system, rather than the systemic immune system, plays fundamental roles in the host's defense against Mtb infection. Therefore, the development of new vaccines and novel delivery routes capable of directly inducing respiratory mucosal immunity is emphasized for achieving enhanced protection from Mtb infection. In this paper, we outline the current state of knowledge regarding the mucosal immunity against Mtb infection, including the development of TB vaccines, and respiratory delivery routes to enhance mucosal immunity are discussed.

PMID: 23213508 [PubMed]

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Advances in pediatric asthma in 2012: Moving toward asthma prevention.

J Allergy Clin Immunol. 2012 Nov 27;

Authors: Szefler SJ

Abstract
Last year's "Advances in pediatric asthma: moving forward" concluded the following: "Now is also the time to utilize information recorded in electronic medical records to develop innovative disease management plans that will track asthma over time and enable timely decisions on interventions in order to maintain control that can lead to disease remission and prevention." This year's summary will focus on recent advances in pediatric asthma on modifying disease activity, preventing asthma exacerbations, managing severe asthma, and risk factors for predicting and managing early asthma, as indicated in Journal of Allergy and Clinical Immunology publications in 2012. Recent reports continue to shed light on methods to improve asthma management through steps to assess disease activity, tools to standardize outcome measures in asthma, genetic markers that predict risk for asthma and appropriate treatment, and interventions that alter the early presentation of asthma to prevent progression. We are well on our way to creating a pathway around wellness in asthma care and also to use new tools to predict the risk for asthma and take steps to not only prevent asthma exacerbations but also to prevent the early manifestations of the disease and thus prevent its evolution to severe asthma.

PMID: 23199603 [PubMed - as supplied by publisher]

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Association of Vitamin D Receptor Gene Polymorphisms with susceptibility to asthma in Tunisian children: a Case Control Study.

Hum Immunol. 2012 Nov 28;

Authors: Maalmi H, Sassi FH, Berrais A, Ammar J, Hamzaoui K, Hamzaoui A

Abstract
BACKGROUND: Vitamin D and its nuclear receptor (VDR) are linked to asthma in a genetic and immunologic basis. Polymorphisms in the VDR gene may alter the actions of vitamin D and then influence the development and the severity of asthma. AIMS: We aimed at elucidating the genetic association of VDR gene polymorphisms with susceptibility to asthma in Tunisian children and with serum vitamin D levels. METHODS: The study included 155 patients recruited from Abderrahmen MAMI hospital in Tunisia and Two hundred twenty five healthy individuals matched with patients in age and sex for comparison. VDR genotypes were determined by PCR-RFLP method using endonuclease FokI, BsmI, TaqI and ApaI and Vitamin D was assessed with a radioimmunoassay kit. RESULTS: The distribution of genotype frequencies differed significantly between asthmatics and controls (FokI: P=0.04; BsmI: P= 0.006; TaqI: P= 0.006). Haplotype analyses revealed a significant association between bAt and bat haplotypes and asthma (P=0.00076, P=0.016). When patients were stratified according to atopic status and stage of severity, no significant association was detected with VDR variants. No association was found between VDR SNPs and serum 25-hydroxyvitamin D levels. CONCLUSION: Our study shows a relation between VDR gene polymorphisms and susceptibility to asthma in children.

PMID: 23200756 [PubMed - as supplied by publisher]