Table 2.
Recent studies on BCG NSEs following the SAGE working group's systematic review on vaccine NSEs to associate the reduction in all-cause mortality with immunological outcomes.
Country (study period) | Type of study | Subject follow-up period | % Reduction in all-cause mortality or morbidity (95% CI) | Testing for NSEs | References |
---|---|---|---|---|---|
Denmark (2012-2015) |
Randomized | 15 months | No significant reduction | Potentiating effect of BCG on cytokine production (TNF-α, IL-6, IL-10) | (55, 56) |
Uganda (2015-) |
Randomized | 10 weeks | Unpublished | IL-1β, IL-6, IL-10, TNF-α, and IFN-γ cytokine levels after secondary stimulation. H3K4me3 on cytokine genes in peripheral blood monocytes. |
(57) (results on mortality unpublished) |
Guinea-Bissau (2008-2013) |
Randomized | 12 months | 30% (−4; 53) | Measure increases in responses to heterologous stimulation (elevated IL-1β, IL-6, TNF-α, and IFN-γ response) |
(20, 58) |
Spain (2015) |
Retrospective cohort | N/A | 41.4% (40.3; 42.5) | None | (59) |