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Table 1 Objectives for immunological sub-studies

From: Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial

Sub-study

Primary objectives

Secondary objectives

Cytokine sub-study

Cross-sectional comparison of IL-1β, IL-6, TNF-α and IFN-γ cytokine levels following overnight in-vitro stimulation with S. aureus, S. pneumoniae, E. coli, C. albicans and Poly I:C/CpG between the two intervention groups:

Longitudinal analysis of within-infant changes in innate cytokine production following in-vitro stimulation with S. aureus, S. pneumoniae, E. coli, C. albicans and Poly I:C/CpG.

1. Shortly after birth intervention (BCG vaccination/no vaccination): Aim 1

2. Six weeks post-birth intervention (immediately prior to first dose of primary vaccination): Aim 2

3. Shortly after 6-week intervention (BCG vaccination/no vaccination): Aim 3

4. Three weeks post-6-week intervention (immediately prior to second dose of primary vaccinations): Aim 3

Iron sub-study

Cross-sectional comparison of transferrin saturation and hepcidin levels between the two intervention groups:

Cross-sectional comparison of serum iron, total iron binding capacity, ferritin, transferrin, haemoglobin and red cell parameters at the above time-points.

1. Shortly after birth intervention (BCG vaccination/no vaccination): Aim 1

Longitudinal analysis of within-infant changes to iron status following in-vivo non- specific stimulation (provided by primary vaccinations)

2. Six weeks post-birth intervention (shortly after first dose of primary vaccination): Aim 2

3. Shortly after 6-week intervention (BCG vaccination/no vaccination): Aim 3

4. Three weeks post-6-weeks intervention (shortly after second dose of primary vaccination): Aim 3

Epigenetic sub-study

Cross-sectional comparison of monocyte histone-3 lysine 4 trimethylation (H3K4me3) at the promoter region of pro-inflammatory cytokines between the 2 intervention groups:

Longitudinal analysis of within-infant changes in monocyte epigenetic modification.

1. Shortly after birth intervention (BCG vaccination/no vaccination): Aim 1

2. Six weeks post-birth intervention (immediately prior to first dose of primary vaccination): Aim 2