Immune Response Clinical Trial
Official title:
A Pilot Study of the Impact of BCG Administration on the Immunogenicity of Serogroup C Meningococcal Conjugate Vaccine in Healthy Infants
The Bacille Calmette-Guérin (BCG) vaccine is the only vaccine licenced to prevent
tuberculosis (TB). The stimulus it gives to the immune system allows it to respond more
effectively to a subsequent infection with TB.
Many studies have shown that BCG is effective in reducing deaths from TB disease,
particularly in children. However, there is also evidence that in countries with a relatively
high death rate, BCG reduces this death rate but by more than would be expected by its effect
on TB alone. This controversial but important finding warrants further and serious
consideration. One possibility is that BCG, in addition to stimulating the immune system
against TB, also has a positive effect on the way the immune system works more generally.
This might mean a more effective response to serious infections that are completely unrelated
to TB, or the ability to respond better to other routine childhood vaccines, or to maintain
such responses for longer. In these examples, the timing of BCG administration in relation to
other vaccines could be crucial.
This study will recruit 30 healthy babies who would not routinely be offered the BCG vaccine
in the UK within the first week of life. Babies will be assigned at random to one of three
groups of ten babies each. BCG will be given to one group of babies around birth, one at
three months old and the last group will not get BCG during the study. Babies will stay in
the study until 13 months old and have five blood tests over this period.
This preliminary study will look at the participants' blood to see if there are differences
in the immune system, or its response to the MenC childhood meningitis vaccine or the pattern
of genes activated after BCG has been given.
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