Neonatal Bacille Calmette-Guérin vaccination and tuberculin skin test reactions at 2- and 6-months: Effects on mortality up to 1 year of age.

Bacille Calmette-Guérin (BCG) Heterologous effects of vaccines Infant mortality Mantoux reaction Non-specific effects of vaccines Purified Protein Derivative (PPD) Tuberculin Skin Test (TST)

Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
08 12 2021
Historique:
received: 14 04 2021
revised: 10 06 2021
accepted: 25 06 2021
pubmed: 7 7 2021
medline: 27 1 2022
entrez: 6 7 2021
Statut: ppublish

Résumé

In randomized trials, Bacille Calmette-Guérin (BCG) vaccine has been associated with reduced all-cause mortality. BCG-induced Tuberculin Skin Test (TST) reactions have also been associated with reduced all-cause mortality. We aimed to assess the association between TST responses and subsequent mortality in three birth cohorts and conducted a meta-analysis of existing studies. Observational study within three Guinea-Bissau BCG trial birth cohorts (conducted 2002-04, 2009-2013 and 2014-18) that encompassed children who were BCG-vaccinated within 28 days with TSTs performed at 2- (n = 1389) and 6-months (n = 2635) of age. We evaluated TST reaction determinants by binomial regression and assessed the association between TSTs > 1 mm (reactors) vs. ≤ 1 mm (non-reactors) and subsequent mortality risk up to age 12 months in Cox-models providing Mortality Rate Ratios (MRRs). We searched PubMed for studies to calculate meta-estimates of the association between TST reactivity by age 2- and 6-months and all-cause mortality. Large post-vaccination wheal size was associated with 6-month TST positivity and so was receiving BCG-Denmark or BCG-Japan, compared with BCG-Russia. By age 2 months, 22% (302/1389) of infants were TST reactors with a 2-12-month mortality risk of 1.7% (5/302) vs. 3.3% (36/1087) for non-reactors, the corresponding reactor/non-reactor MRR = 0.49 (0.19-1.26). By age 6 months, 44% (1149/2635) of infants were reactors and the 6-12-month mortality risk was 0.4% (4/1149) vs. 0.6% (9/1486) for non-reactors, the MRR = 0.87 (0.27-2.86). The literature search provided 3 studies. The meta-analysis revealed a uniform pattern of reduced mortality associated with TST reactivity, a TST response by 2 months being associated with an MRR of 0.59 (0.39-0.90); for 6-month TST responses the MRR was 0.65 (0.43-1.00). Among BCG-vaccinated infants, TST reactions were associated with markedly reduced mortality. Improved vaccination technique and using certain BCG strains could lead to a higher TST reaction prevalence, which would enhance BCG's beneficial non-specific effects.

Sections du résumé

BACKGROUND
In randomized trials, Bacille Calmette-Guérin (BCG) vaccine has been associated with reduced all-cause mortality. BCG-induced Tuberculin Skin Test (TST) reactions have also been associated with reduced all-cause mortality. We aimed to assess the association between TST responses and subsequent mortality in three birth cohorts and conducted a meta-analysis of existing studies.
METHODS
Observational study within three Guinea-Bissau BCG trial birth cohorts (conducted 2002-04, 2009-2013 and 2014-18) that encompassed children who were BCG-vaccinated within 28 days with TSTs performed at 2- (n = 1389) and 6-months (n = 2635) of age. We evaluated TST reaction determinants by binomial regression and assessed the association between TSTs > 1 mm (reactors) vs. ≤ 1 mm (non-reactors) and subsequent mortality risk up to age 12 months in Cox-models providing Mortality Rate Ratios (MRRs). We searched PubMed for studies to calculate meta-estimates of the association between TST reactivity by age 2- and 6-months and all-cause mortality.
RESULTS
Large post-vaccination wheal size was associated with 6-month TST positivity and so was receiving BCG-Denmark or BCG-Japan, compared with BCG-Russia. By age 2 months, 22% (302/1389) of infants were TST reactors with a 2-12-month mortality risk of 1.7% (5/302) vs. 3.3% (36/1087) for non-reactors, the corresponding reactor/non-reactor MRR = 0.49 (0.19-1.26). By age 6 months, 44% (1149/2635) of infants were reactors and the 6-12-month mortality risk was 0.4% (4/1149) vs. 0.6% (9/1486) for non-reactors, the MRR = 0.87 (0.27-2.86). The literature search provided 3 studies. The meta-analysis revealed a uniform pattern of reduced mortality associated with TST reactivity, a TST response by 2 months being associated with an MRR of 0.59 (0.39-0.90); for 6-month TST responses the MRR was 0.65 (0.43-1.00).
CONCLUSION
Among BCG-vaccinated infants, TST reactions were associated with markedly reduced mortality. Improved vaccination technique and using certain BCG strains could lead to a higher TST reaction prevalence, which would enhance BCG's beneficial non-specific effects.

Identifiants

pubmed: 34226104
pii: S0264-410X(21)00839-2
doi: 10.1016/j.vaccine.2021.06.077
pii:
doi:

Substances chimiques

BCG Vaccine 0
Tuberculin 0

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

7286-7294

Informations de copyright

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Frederik Schaltz-Buchholzer (F)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, OPEN, Department of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark. Electronic address: buchholzer@gmail.com.

Adam Roth (A)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Public Health Agency of Sweden, Solna, Sweden; Institution for Translation Medicine, Lund University, Malmö, Sweden.

L Charlotte J de Bree (LCJ)

Bandim Health Project, OPEN, Department of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark; Department of Internal Medicine, Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.

Sofie Biering-Sørensen (S)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.

Clara Amalie Gade Timmermann (CAG)

Research Unit of Clinical Pharmacology, Pharmacy and Environmental Medicine, Uni. Southern Denmark, Odense, Denmark; Department of Public Health, University of Copenhagen, Copenhagen, Denmark.

Ivan Monteiro (I)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.

Peter Aaby (P)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau.

Christine Stabell Benn (CS)

Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau; Bandim Health Project, OPEN, Department of Clinical Research, Uni. Southern Denmark and Odense University Hospital, Odense, Denmark; Danish Institute of Advanced Science, Uni. Southern Denmark, Odense, Denmark.

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