Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose

Abstract

A vaccine against serogroup B meningococcus has recently been licensed for use in Europe 1 and is being considered for licensure in Canada. This vaccine, known as multicomponent serogroup B men in gococcal (4CMenB) vaccine, consists of 3 recombinant proteins: factor H binding protein (fHbp), Neisseria ad he sin A (NadA) and Neisseria heparin binding antigen (NHBA) combined with detoxified outer membrane vesicles from the strain responsible for an epidemic of serogroup B meningococcal disease in New Zealand (NZ98/254). Clinical trials of 4CMenB have shown it to be immunogenic against reference strains selected to specifically express one of the vaccine antigens.2-6 On the basis of these trials, the approved schedule for infants aged 2 to 5 months is 3 doses given at least 1 month apart, with a booster dose given at 12 to 23 months of age. 7 The persistence of vaccineinduced antibodies throughout childhood following this booster dose is unknown, but it is particularly relevant because the incidence of invasive serogroup B meningococcal disease in children aged 1 to 4 years is second only to the incidence in children less than 1 year of age. 8In this study, we assessed the persistence of these bactericidal antibodies in children aged 40-44 months who had previously received either 4CMenB or a vaccine containing the recombinant proteins alone (recombinant protein serogroup B meningococcal [rMenB] vaccine) at 2, 4, 6 and 12 months of age. 3 We also assessed the immunogenicity and reactogenicity of a booster dose. This article has been peer reviewed. Methods Participants

Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months

“…9 Here, we present the secondary outcomes of antibody persistence at 60 months of age and the immunogenicity, safety and tolerability of a 2-dose catch-up regimen of 4CMenB vaccine administered at 60 and 62 months.…”

“…Of these 147 infants, 70 participated in the 40-month extension study, 9 in which those who originally received 4 doses received 1 additional dose (at 40 mo) and those who originally received 1 dose received 2 additional doses (at 40 and 42 mo) of the vaccine originally received. These groups are referred to here as follows: 4CMenB 2,4,6,12,40; rMenB 2,4,6,12,40; 4CMenB 12,40,42; and rMenB 12,40,42.…”

“…Details of the rMenB vaccine received by some groups in the earlier studies can be found elsewhere. 9 All vaccines were 0.5 mL in volume and were administered into the deltoid muscle of the nondominant arm.…”

“…These cards listed potential local and systemic reactions, based on previous vaccine studies 7,9 and graded from mild to severe according to interference with normal activities. Additional space was provided for parents to record any other symptoms.…”

“…Additional space was provided for parents to record any other symptoms. Adverse events Enrolled in original study 7 Enrolled in follow-on study (at 40 mo) 9 Included in MITT immunogenicity analysis of antibacterial persistence requiring medical attendance and all serious adverse events (such as admission to hospital) were recorded for the duration of the study.…”