Bivalent rLP2086 Vaccine (Trumenba®): A Review in Active Immunization Against Invasive Meningococcal Group B Disease in Individuals Aged 10–25 Years

Abstract

Bivalent rLP2086 vaccine (Trumenba(®)) [hereafter referred to as rLP2086] is a Neisseria meningitidis serogroup B (MenB) vaccine recently licensed in the USA for active immunization to prevent invasive disease caused by MenB in individuals 10-25 years of age. rLP2086, which contains two variants of the meningococcal surface protein factor H-binding protein (fHBP), was approved by the FDA under the accelerated approval pathway after the immunogenicity of the vaccine was demonstrated in several phase II trials. This article reviews the immunogenicity and reactogenicity of rLP2086 as demonstrated in the trials with a focus on the US setting and on use of the vaccine as per FDA-approved labeling. rLP2086 is approved in the USA as a three-dose series administered in a 0-, 2-, and 6-month schedule. In the phase II trials, rLP2086 elicited a robust immune response against a panel of MenB test strains. A strong immune response was evident in a marked proportion of subjects after two vaccine doses, with a further increase after a third dose. The four primary test strains used were selected to be representative of MenB strains prevalent in the USA, with each expressing an fHBP variant heterologous to the vaccine antigens. rLP2086 was generally well tolerated in the trials, with most adverse reactions being mild to moderate in severity. Although some questions remain, including the duration of the protective response, rLP2086 vaccine has the potential to be a valuable tool for the prevention of invasive MenB disease.

The Global Meningococcal Initiative: global epidemiology, the impact of vaccines on meningococcal disease and the importance of herd protection

“…The vaccine is reactogenic, with transient fever seen in infants peaking~6 h after vaccination and resolving within 2-3 days, particularly after the primary dose; the reaction can be increased by concomitant administration with other routine infant vaccinations, but is manageable with paracetamol, with only 2-3% of patients requiring additional medical attention [94]. A second subcapsular vaccine, Trumenba ® , contains two fHbp variants [29,97], and was approved by the FDA in 2014 for use in adolescents and young adults aged 10-25 years [98].…”

Novel approaches for the design, delivery and administration of vaccine technologies

“…This gives them inherent immunostimulatory properties, as they naturally contain several pathogen-associated molecular patterns on their surface, which makes them an adjuvanting particle. To date, two outer membrane vesicle vaccines for meningitis B (Bexsero and Trumenba) have been licensed for use in humans [132,133]. Antigens within the lumen of the vesicles were believed to be hidden from B cell recognition.…”

“…One of the difficulties of using outer membrane vesicles to target an antigen non-native to the producing bacteria is that the vesicles naturally contain many immunogenic components, which could lead to an immune response dominantly targeting the vesicle instead of the antigen of interest. To date, two outer membrane vesicle vaccines for meningitis B (Bexsero and Trumenba) have been licensed for use in humans [132,133].…”

Characterisation of carried and invasive Neisseria meningitidis isolates in Shanghai, China from 1950 to 2016: implications for serogroup B vaccine implementation

“…Prevention of MenB IMD is challenging due to the poorly immunogenic polysaccharide capsule and concerns about autoimmunity due to its structural similarity to human tissue. To address this deficit, two protein-based vaccines, Bexsero® (4CMenB) and Trumenba® (bivalent rLP2086), were developed and licensed in Europe and the USA [10, 11]. Bexsero® is composed of factor H binding protein (fHbp), Neisserial heparin-binding antigen (NHBA), Neisseria adhesin A (NadA), and PorA, while Trumenba® contains two fHbp-subfamily variants [12].…”