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Kim, Lee, Kim, Kim, Lee, Lee, Cho, Kwon, Lee, Jo, Ha, Lee, Seung, and BCG Lymphadenitis Survey Committee: The Incidence Rate of Lymphadenitis after Bacille Calmette—Guérin (BCG) Vaccination
Original Article

Pediatr Infect Vaccine 2016;23(1):54-61.

Published online: 21 January 2016

DOI: https://doi.org/10.14776/piv.2016.23.1.54

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

Jaehong Kim1, Kyujin Lee1, Jong-Hyun Kim1, Seong Joon Kim1, Soo Young Lee1, Hye Jin Lee1, Kyung Soon Cho1, Young Joo Kwon2, Byoung Chan Lee2, Sang Min Jo2, Jeong Hun Ha3, Yoon Kyung Lee4, So Jin Seung4; 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

Received 27 October 201529 October 2015       Accepted 29 October 2015

Copyright © 2016 The Korean Society of Pediatric Infectious Diseases

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

Bacille Calmette-Guérin (BCG) lymphadenitis is a relatively frequent local adverse reactions after BCG vaccination. Its incidence rate is usually <1°/o. 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

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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.
piv-23-54f1.tif
Table 1.
Demographic Findings of study Population
  Tokyo strain percutaneous Dannish strain intradermal P value
Number 2,501 721  
Sex
  Male 1.261 (50.4%) 426 (59.1%) <0.001
  Female 1 240 (49.6%) 295(40.9%) <0 001
Age     0.001
  Mean±S.D. 581±232 days 19.2 months 550±231 days 18.1 months  
  Median 573 days 18.9 months 531 days 17.5 months  
Table 2.
Characteristics of Cases with BCG Lymphadenitis
No BCG strain Sex Age at survey Region Size (diameter) Suppuration Treatment Prognosis
1 Tokyo M 8m axilla 0.5 cm No Observation spontaneous resolution
2 Tokyo M 15m axilla 1.5 cm No Observation spontaneous resolution
3 Tokyo M 26m axilla 2.0 cm No Surgerv  
4 Tokyo M 26m axilla 2.0 cm N0 Observation spontaneous resolution
5 Tokyo M 31m axilla 2.0 cm Yes Surgery  
6 Danish M 15m axilla 3.0 cm No Surqerv  
7 Danish F 16m axilla 3.0 cm Yes Surgery  
8 Danish M 25m supra-clavicular 2.0 cm Yes Compression & Drain  
9 Danish F 26M axilla 1.0 cm N0 Surgery  
10 Danisn F 27M axilla 1.0 cm NO Surgery  
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