Open Access, Peer-reviewed
pISSN 2384-1079
eISSN 2384-1087
    Pediatr Infect Vaccine. 2016 Apr;23(1):54-61. Korean.
    Published online Apr 30, 2016.
    https://doi.org/10.14776/piv.2016.23.1.54
    Copyright © 2016 The Korean Society of Pediatric Infectious Diseases
    Original Article

    The Incidence Rate of Lymphadenitis after Bacille Calmette-Guérin (BCG) Vaccination

    Jaehong Kim,1 Kyujin Lee,1 Jong-Hyun Kim,1 Seong Joon Kim,1 Soo Young Lee,1 Hye Jin Lee,1 Kyung Soon Cho,1 Young Joo Kwon,2 Byoung Chan Lee,2 Sang Min Jo,2 Jeong Hun Ha,3 Yoon Kyung Lee,4 So Jin Seung,4 and BCG Lymphadenitis Survey Committee
      • 1Department of Pediatrics, School of Medicine, The Catholic University of Korea, Seoul, Korea.
      • 2Department of Pediatrics, Sungsae Hospital, Pyeongtaek, Korea.
      • 3Dr. Ha Jeong Hun's Pediatric Clinic, Seoul, Korea.
      • 4Hanmaeum Pediatric Clinic, Suwon, Korea.
    • Corresponding author (Email: jh00mn@catholic.ac.kr )
    Received October 27, 2015; Revised October 29, 2015; Accepted October 29, 2015.

    Abstract

    Purpose

    Bacille Calmette-Guérin (BCG) lymphadenitis is a relatively frequent local adverse reactions after BCG vaccination. Its incidence rate is usually <1%. However, this rate may be different according to BCG strain, vaccination method or skill, etc. In the Republic of Korea, two BCG strains are used: intradermal Danish-1331 or percutaneous Tokyo-172. We surveyed the incidence rates of BCG lymphadenitis.

    Methods

    This survey was performed in total 25 centers (5 general hospitals, 20 private pediatric clinics). Immunized type of BCG strain in study subjects was verified by directly observing the scar. The occurrence of BCG lymphadenitis was asked to their parent. In cases of BCG lymphadenitis, location, diameter size, progression of suppuration, and treatment method were investigated, as well.

    Results

    The total number of study subjects was 3,342. Among these, the subjects suitable for enrollment criteria (total 3,222; Tokyo strain 2,501, Danish strain 721) were analyzed. BCG lymphadenitis regardless of its size developed in each five of subjects per strains, therefore, its incidence rate was 0.20% in Tokyo and 0.69% in Danish strain, respectively (P=0.086). However, when applying the WHO criteria - the development of lymph node swelling with diameter 1.5 cm or more, the incidence rate of BCG lymphadenitis was 0.16% (4 cases) in Tokyo and 0.42% (3 cases) in Danish strain, respectively.

    Conclusions

    The incidence rate of lymphadenitis in two BCG types, percutaneous Tokyo and intradermal Danish strain BCG, is 0.20% and 0.69%, respectively. Both rates are acceptable.

    Keywords
    Bacille Calmette Guerin (BCG); lymphadenitis; adverse reaction; Dannish strain; Tokyo strain

    Figures

    Fig. 1
    The flow chart how to select the study population. Abbreviations: BCG, Bacille Calmette-Guérin; D, Dannish strain intradermal; N, number; T, Tokyo strain percutaneous.

    Tables

    Table 1
    Demographic Findings of Study Population

    Table 2
    Characteristics of Cases with BCG Lymphadenitis

    References

      1. World Health Organization. BCG vaccine: WHO position paper. Wkly Epidemiol Rec 2004;79:27–38.
      1. Milstien JB, Gibson JJ. Quality control of BCG vaccine by WHO: a review of factors that may influence vaccine effectiveness and safety. Bull World Health Organ 1990;68:93–108.
      1. Lee HJ, editor. The Korean Pediatric Society. Immunization guideline. 7th ed. Seoul: The Korean Pediatric Society; 2012. pp. 40-54.
      1. Lotte A, Wasz-Höckert O, Poisson N, Dumitrescu N, Verron M, Couvet E. A bibliography of the complications of BCG vaccination. A comprehensive list of the world literature since the introduction of BCG up to July 1982, supplemented by over 100 personal communications. Adv Tuberc Res 1984;21:194–245.
      1. World Health Organization. Guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization. Manila: Western Pacific Regional Office, WHO; 1999.
      1. Talbot EA, Perkins MD, Silva SF, Frothingham R. Disseminated bacille Calmette-Guérin disease after vaccination: case report and review. Clin Infect Dis 1997;24:1139–1146.
      1. Ustvedt HJ. Local reactions in BCG vaccination. Bull World Health Organ 1950;2:441–468.
      1. Goraya JS, Virdi VS. Bacille Calmette-Guérin lymphadenitis. Postgrad Med J 2002;78:327–329.
      1. Mori T, Yamauchi Y, Shiozawa K. Lymph node swelling due to bacille Camette-Guerin vaccination with multipuncture method. Tuber Lung Dis 1996;77:269–273.
      1. Daoud W. Control of an outbreak of BCG complications in Gaza. Respirology 2003;8:376–378.
      1. Jeena PM, Chhagan MK, Topley J, Coovadia HM. Safety of the intradermal Copenhagen 1331 BCG vaccine in neonates in Durban, South Africa. Bull World Health Organ 2001;79:337–343.
      1. R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2015 [Assessed 26 October 2015].
        Available at: https://www.R-project.org/.
      1. Corbel MJ, Fruth U, Griffiths E, Knezevic I. Report on a WHO consultation on the characterisation of BCG strains, Imperial College, London 15–16 December 2003. Vaccine 2004;22:2675–2680.
      1. Smith KC, Orme IM, Starke JR. Tuberculosis vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia: Elsevier Inc; 2013. pp. 789-811.
      1. Fine PEM, Carneiro IAM, Milstien JB, Clements CJ. In: Issues relating to the use of BCG in immunization programmes: a discussion document. Geneva: WHO; 1999.
      1. Samileh N, Ahmad S, Farzaneh A, Shahnaz R, Lida F, Mohammad N. Immunity status in children with Bacille Calmette-Guerin adenitis. A prospective study in Tehran, Iran. Saudi Med J 2006;27:1719–1724.
      1. Serour F, Mizrahi A, Somekh E, Feinberg J, Picard C, Casanova JL, et al. Analysis of the interleukin-12/interferon-gamma pathway in children with non-tuberculous mycobacterial cervical lymphadenitis. Eur J Pediatr 2007;166:835–841.
      1. Yeganeh M, Heidarzade M, Pourpak Z, Parvaneh N, Rezaei N, Gharagozlou M, et al. Severe combined immunodeficiency: a cohort of 40 patients. Pediatr Allergy Immunol 2008;19:303–306.
      1. Lee PP, Chan KW, Jiang L, Chen T, Li C, Lee TL, et al. Susceptibility to mycobacterial infections in children with X-linked chronic granulomatous disease: a review of 17 patients living in a region endemic for tuberculosis. Pediatr Infect Dis J 2008;27:224–230.
      1. Nyerges G, Drinoczy M. Significance of the number of viable units in BCG vaccines. Dev Biol Stand 1986;58:331–336.
      1. Teulieres L, Diouf MA, Chaud P, Saint-Cyr A, Saliou P. Comparative trial of administration of half (0.05 mg) and quarter (0.025 mg) dose of intradermal Pasteur BCG on 291 infants from birth to 1 year in French Guyana. Vaccine 1991;9:521–524.
      1. Teo SS, Smeulders N, Shingadia DV. BCG vaccine-associated suppurative lymphadenitis. Vaccine 2005;23:2676–2679.
      1. Gheorghiu M. The present and future role of BCG vaccine in tuberculosis control. Biologicals 1990;18:135–141.
      1. Bolger T, O'Connell M, Menon A, Butler K. Complications associated with the bacille Calmette-Guerin vaccination in Ireland. Arch Dis Child 2006;91:594–597.
      1. World Health Organization. Expanded programme on immunization, biologicals unit: lymphadenitis associated with BCG immunization. Wkly Epidemiol Rec 1988;63:381–388.
      1. Baek HS, Chang JY, Moon SJ, Oh SH. Lymphadenitis following intradermal BCG vaccination. Korean J Pediatr 2006;49:46–50.
      1. Hwang JS, Choi YY, Ma JS, Hwang TJ. A clinical study on BCG lymphadenitis. Korean J Pediatr 1997;40:614–618.
      1. Lee JS, Sohn YM. Observation of response to PPD skin test and local side reactions at multiple inoculation sites after percutaneous inoculation with BCG Tokyo 172 strain. Korean J Pediatr Infect Dis 2000;7:201–210.
      1. Oh MH, Kim KH, Sim JG. The clinical study on conversion rate of Mantoux test, change of local lesion and complication after multipuncture BCG vaccination in neonates. Korean J Pediatr 1997;40:1120–1130.
      1. Kim HJ, Oh SY, Lee JB. In: Comparison of each strains (Pasteur, Danish, Tokyo) of BCG efficacy using tuberculin test and adverse reactions. Osong: Korea Center for Diseases Control and Prevention; 2008.
      1. Goraya JS, Virdi VS. Treatment of Calmette-Guerin Bacillus adenitis: a metaanalysis. Pediatr Infect Dis J 2001;20:632–634.
      1. Banani SA, Alborzi A. Neddle aspiration for suppurative post-BCG adenitis. Arch Dis Child 1994;71:446–447.
    Cited by
    Crossref 1
    Google Scholar 
    MeSH Terms
    Cicatrix
    Hospitals, General
    Humans
    Incidence*
    Lymph Nodes
    Lymphadenitis*
    Mycobacterium bovis
    Parents
    Republic of Korea
    Suppuration
    Vaccination*
    Metrics
    Share
    Figures
    slide

    1 / 1

    Tables
    slide
    slide

    1 / 2

    PERMALINK