Abstract
Background and rationaleThe four-component capsular group B meningococcal vaccine (4CMenB) was introduced into the national immunisation schedule in the UK in September 2015 for infants in a 2 + 1 schedule at two, four and 12 months of age. A two-dose immunisation schedule for adolescents was also considered but was not found to be cost-effective in view of the relatively low rates of disease in this age group. Uncertainty about the longevity of protection induced by the vaccine and lack of certainty about an anamnestic response in primed individuals contributed to this decision.Methods/DesignThis study is an open-label, descriptive immunogenicity analysis. Up to 113 participants will be recruited, including up to 83 children who are now aged 11 years and took part in previous trials involving the administration of 4CMenB to infants, plus a group of 30 naïve age-matched controls. All previously immunised participants will receive one booster dose of 4CMenB. The 30 naïve participants will be randomised to receive two doses of 4CMenB either at 0 and 28 days or 0 and 365 days. Blood samples will be collected from all participants at 0, 28, 180 and 365 days. The primary endpoint will explore immunogenicity at day 0 and 180 in previously immunised and naïve participants. Secondary outcomes will include investigating the persistence of antibody protection in previously immunised participants at the beginning of the study, describing the characteristics of the memory B-cell responses in previously immunised participants, and measuring reactogenicity in all participants following 4CMenB doses.DiscussionThis study aims to describe whether or not a single booster dose of 4CMenB given to those who have received an infant course of 4CMenB induces a recall immune response, while concurrently describing immune responses in naïve children of the same age. If an anamnestic response is proven, a single dose adolescent booster could be envisaged as an addition to the current UK vaccination schedule.Trial registrationEudraCT, 2017–004732-11. ISRCTN, ISRCTN16774163. Registered on 10 May 2018 (retrospectively registered).
Highlights
Background and rationaleThe four-component capsular group B meningococcal vaccine (4CMenB) was introduced into the national immunisation schedule in the UK in September 2015 for infants in a 2 + 1 schedule at two, four and 12 months of age
This study aims to describe whether or not a single booster dose of Four component meningococcal B vaccine (4CMenB) given to those who have received an infant course of 4CMenB induces a recall immune response, while concurrently describing immune responses in naïve children of the same age
B-cell responses will be analysed by the ability of 4CMenB to stimulate a detectable increase in IgG, IgA and IgM-producing antigen-specific memory B-cells enumerated by Enzyme-linked immunosorbent spot assay (ELISPOT) using plates coated with vaccine antigens (OMVs, factor H binding protein (fHbp), neisserial heparin binding antigen (NHBA), neisserial adhesin A (NadA) and/or PorA)
Summary
The four-component capsular group B meningococcal vaccine (4CMenB) was introduced into the national immunisation schedule in the UK in September 2015 for infants in a 2 + 1 schedule at two, four and 12 months of age. Concerns about a capsular group B meningococcal vaccine based on the polysaccharide capsule inducing poor immunogenicity and possibly eliciting a harmful autoimmune response [2] led to the development of an alternative approach using subcapsular proteins. Adolescents are responsible for the majority of nasopharyngeal carriage of meningococcus [5] and the majority of transmission. They suffer from the second highest incidence rate of invasive meningococcal disease (IMD) of any age group [6]. Investing in an adolescent MenB booster programme could further reduce incident cases and may interrupt transmission of hyperinvasive MenB strains, reducing overall disease burden
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