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 |