PMID- 27749923
OWN - NLM
STAT- MEDLINE
DCOM- 20170531
LR  - 20220408
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 11
IP  - 10
DP  - 2016
TI  - Differential Adverse Event Profiles Associated with BCG as a Preventive 
      Tuberculosis Vaccine or Therapeutic Bladder Cancer Vaccine Identified by 
      Comparative Ontology-Based VAERS and Literature Meta-Analysis.
PG  - e0164792
LID - 10.1371/journal.pone.0164792 [doi]
LID - e0164792
AB  - M. bovis strain Bacillus Calmette-Guerin (BCG) has been the only licensed live 
      attenuated vaccine against tuberculosis (TB) for nearly one century and has also 
      been approved as a therapeutic vaccine for bladder cancer treatment since 1990. 
      During its long time usage, different adverse events (AEs) have been reported. 
      However, the AEs associated with the BCG preventive TB vaccine and therapeutic 
      cancer vaccine have not been systematically compared. In this study, we 
      systematically collected various BCG AE data mined from the US VAERS database and 
      PubMed literature reports, identified statistically significant BCG-associated 
      AEs, and ontologically classified and compared these AEs related to these two 
      types of BCG vaccine. From 397 VAERS BCG AE case reports, we identified 64 AEs 
      statistically significantly associated with the BCG TB vaccine and 14 AEs with 
      the BCG cancer vaccine. Our meta-analysis of 41 peer-reviewed journal reports 
      identified 48 AEs associated with the BCG TB vaccine and 43 AEs associated with 
      the BCG cancer vaccine. Among all identified AEs from VAERS and literature 
      reports, 25 AEs belong to serious AEs. The Ontology of Adverse Events (OAE)-based 
      ontological hierarchical analysis indicated that the AEs associated with the BCG 
      TB vaccine were enriched in immune system (e.g., lymphadenopathy and 
      lymphadenitis), skin (e.g., skin ulceration and cyanosis), and respiratory system 
      (e.g., cough and pneumonia); in contrast, the AEs associated with the BCG cancer 
      vaccine mainly occurred in the urinary system (e.g., dysuria, pollakiuria, and 
      hematuria). With these distinct AE profiles detected, this study also discovered 
      three AEs (i.e., chills, pneumonia, and C-reactive protein increased) shared by 
      the BCG TB vaccine and bladder cancer vaccine. Furthermore, our deep 
      investigation of 24 BCG-associated death cases from VAERS identified the 
      important effects of age, vaccine co-administration, and immunosuppressive status 
      on the final BCG-associated death outcome.
FAU - Xie, Jiangan
AU  - Xie J
AD  - Key Laboratory of Dependable Service Computing in Cyber Physical Society, 
      Ministry of Education, College of Computer Science, Chongqing University, 
      Chongqing, China.
AD  - Unit for Laboratory Animal Medicine, Department of Microbiology and Immunology, 
      Center for Computational Medicine and Bioinformatics, University of Michigan 
      Medical School, Ann Arbor, Michigan, United States of America.
FAU - Codd, Christopher
AU  - Codd C
AD  - College of Literature, Science, and the Arts, University of Michigan, Ann Arbor, 
      Michigan, United States of America.
FAU - Mo, Kevin
AU  - Mo K
AD  - College of Literature, Science, and the Arts, University of Michigan, Ann Arbor, 
      Michigan, United States of America.
FAU - He, Yongqun
AU  - He Y
AD  - Unit for Laboratory Animal Medicine, Department of Microbiology and Immunology, 
      Center for Computational Medicine and Bioinformatics, University of Michigan 
      Medical School, Ann Arbor, Michigan, United States of America.
LA  - eng
GR  - R01 AI081062/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20161017
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (BCG Vaccine)
RN  - 0 (Cancer Vaccines)
RN  - 0 (Tuberculosis Vaccines)
RN  - 9007-41-4 (C-Reactive Protein)
SB  - IM
MH  - BCG Vaccine/*adverse effects/immunology/therapeutic use
MH  - C-Reactive Protein/analysis
MH  - Cancer Vaccines/*adverse effects/immunology/therapeutic use
MH  - Databases, Factual
MH  - Dysuria/etiology
MH  - Humans
MH  - Lymphadenopathy/etiology
MH  - Pneumonia/etiology
MH  - Skin Ulcer/etiology
MH  - Tuberculosis Vaccines/*adverse effects/immunology
MH  - Urinary Bladder Neoplasms/*therapy
PMC - PMC5066964
COIS- The authors have declared that no competing interests exist.
EDAT- 2016/10/18 06:00
MHDA- 2017/06/01 06:00
PMCR- 2016/10/17
CRDT- 2016/10/18 06:00
PHST- 2016/07/25 00:00 [received]
PHST- 2016/10/02 00:00 [accepted]
PHST- 2016/10/18 06:00 [pubmed]
PHST- 2017/06/01 06:00 [medline]
PHST- 2016/10/18 06:00 [entrez]
PHST- 2016/10/17 00:00 [pmc-release]
AID - PONE-D-16-29443 [pii]
AID - 10.1371/journal.pone.0164792 [doi]
PST - epublish
SO  - PLoS One. 2016 Oct 17;11(10):e0164792. doi: 10.1371/journal.pone.0164792. 
      eCollection 2016.