Innate Immune Response Clinical Trial
Official title:
A Randomised, Controlled Trial Investigating the Influence of BCG (Bacillus Calmette-Guérin) and Hepatitis B Immunisation at Birth on Neonatal Immune Responses
Neonatal morbidity and mortality from infectious diseases is of global concern. Childhood
disease-specific immunisation is irrefutably linked to the decline in deaths from these
targeted infections over the last century. However, neonatal immunisation is limited, in
part, by the impaired adaptive immune function in this age group.
There is now an expanding body of evidence for heterologous ('non-specific') effects of
various vaccines used in childhood. This refers to the immunomodulatory capabilities of
vaccines to influence immune outcomes beyond the vaccine's specific targeted disease. The
underlying immunological mechanisms responsible for these effects are incompletely
understood, but evidence is mounting that the innate immune system is central to these
observed effects.
This study is a randomised controlled trial designed to determine the influence of two
commonly administered neonatal immunisations, BCG and Hepatitis B vaccine, given at birth, on
the neonatal immune responses to non-specific antigens.
The investigators will recruit 200 newborns at the Mercy Hospital for Women in Melbourne,
Australia over a 1-year period. These babies will be allocated randomly to one of 4 groups,
receiving these 2 vaccines in different combinations, at 2 set time points. (at birth and 1
week post randomisation) A blood sample will be taken at 1-week post randomisation for in
vitro immunological analyses.
This study will improve current understanding of the influence of vaccines on neonatal
immunity and will help develop strategies exploiting beneficial heterologous ('non-specific')
effects to improve protection against infection in the very young.
n/a
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