COMPAre
Research type
Research Study
Full title
Sources of COmplement in Meningococcal and Pertussis serum bactericidal antibody Assays
IRAS ID
266052
Contact name
Kirsty LeDoare
Contact email
Sponsor organisation
St George's, University of London
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Newborn infants, particularly those who are born preterm, are vulnerable to infection because of their immature immune systems. Group B meningococcal disease (Men B) and pertussis both represent significant risks to the newborn infant.
Infants in the UK are vaccinated against Men B at 2, 4 and 12 months with Bexsero® and against pertussis at 2,3 and 4 months as part of the 6-in-1 vaccine Infanrix hexa®. Additionally, since 2012 pregnant women in the UK have been routinely offered pertussis vaccination during pregnancy to protect the infant in the first few months of life prior to them receiving their own vaccinations.
Serum bactericidal antibody (SBA) assays are important in the assessment of immunity following vaccination and are used in the production, release and licensure of some vaccines and the evaluation of the function of others. SBA assays for pertussis and meningococcal B typically use adult complement from a healthy adult donor pool. There is some concern that using adult complement may not allow an adequate assessment of neonatal immunity because of differences between adult and infant complement. These differences are more pronounced in preterm infants and this raises questions about whether an SBA assay using adult complement sources allows an accurate assessment of neonatal immunity.
In this study we will create a pooled complement source for three different gestational ages, ≥37 gestational weeks, 32-36+6 gestational weeks and less than 32 gestational weeks, which will allow us to compare the results of the pertussis and meningococcal SBA assays when using both standard adult complement and a gestational age appropriate complement source. To do this we will collect cord blood samples from deliveries within the three gestational age groups.
REC name
West of Scotland REC 4
REC reference
19/WS/0105
Date of REC Opinion
10 Jul 2019
REC opinion
Favourable Opinion