Product review on the IMD serogroup B vaccine Bexsero®

Abstract

Bexsero® is a multicomponent vaccine composed of four major proteins of Neisseria meningitidis : the fHbp, NHBA, NadA and PorA. This vaccine was licensed against invasive meningococcal disease (IMD) due to serogroup B isolates. When administered alone, Bexsero® showed a safety profile similar to other childhood vaccines. It provides an excellent immunogenicity but that requires booster doses in infants and young children. Although the vaccine does not seem to impact on acquisition of carriage of serogroup B isolates, it confers protection against isolates of serogroup B harboring distinct but cross-reactive variants of fHbp, NadA and NHBA. Primary vaccination schemes in infancy underwent a rapid increase after a toddler booster suggesting an anamnestic response and the establishment of a memory response. As Bexsero® targets sub-capsular proteins that can be conserved regardless the capsule, the vaccine can be effective against non-B isolates such as isolates of serogroups W and X.

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

“…Licensure of 4CMenB followed an extensive clinical trial programme evaluating immunogenicity and safety/reactogenicity in more than 7000 infants, toddlers, adolescents and adults [ 44 , 81 , 96 ]. Most studies have focused on those age groups at greatest risk (infants, toddlers, and adolescents) with studies demonstrating robust immune responses to each of the three subcapsular target antigens, NadA, fHbp and NHBA, and also towards the OMV PorA1.4 protein [ 44 , 81 , 96 ].…”

“…Licensure of 4CMenB followed an extensive clinical trial programme evaluating immunogenicity and safety/reactogenicity in more than 7000 infants, toddlers, adolescents and adults [ 44 , 81 , 96 ]. Most studies have focused on those age groups at greatest risk (infants, toddlers, and adolescents) with studies demonstrating robust immune responses to each of the three subcapsular target antigens, NadA, fHbp and NHBA, and also towards the OMV PorA1.4 protein [ 44 , 81 , 96 ]. As in other meningococcal vaccine development, as IMD is relatively uncommon, the initial licensure was on the basis of immunogenicity, with an accepted surrogate of protection (hSBA ≥ 1:4), with subsequent post-licensure studies required to demonstrate effectiveness in targeted populations [ 81 ].…”

“…Licensure of 4CMenB followed an extensive clinical trial programme evaluating immunogenicity and safety/reactogenicity in more than 7,000 infants, toddlers, adolescents and adults [ 44 , 81 , 96 ]. While most studies focused on those age groups at greatest risk (infants, toddlers, and adolescents), a number of studies within the 4CMenB development programme specifically evaluated immunogenicity in healthy adults [ 81 , 96 , 100 , 102 – 104 ] (Table 2 and Fig. 4 ).…”

“…local pain, erythema, induration, were mild to moderate in intensity with onset within 3 days after vaccination (after either dose), and the majority resolved within 7 days. The most common solicited systemic AEs included fatigue, headache, myalgia, and malaise [ 81 , 96 , 100 , 102 – 104 , 139 ]. Unsolicited AEs were collected for 1 month after each vaccination.…”

Meningococcal factor H-binding protein: implications for disease susceptibility, virulence, and vaccines

“…, between v2 and 3 fHbps) which is not surprising given the relatedness of these proteins [ 1 , 2 , 53 ]. Consequently, Trumenba consists of two fHbps (belonging to families A and B) [ 54 , 55 ], while Bexsero has a different, single fHbp but with additional antigens [ 56 ].…”