A combined approach to assess the potential coverage of a multicomponent protein-based vaccine.
ABSTRACT Meningococcal disease caused by Neisseria meningitidis serogroup B is a public health concern even in developed countries. Despite glycoconjugate vaccines against the other invasive serogroups (A, C, W135, Y) are already available and successfully introduced in many countries, no vaccine is currently in use for prevention of serogroup B meningitis. A protein based, multicomponent vaccine (4CMenB) has been developed and proposed for prevention of invasive serogroup B meningococcal disease (MenB). This novel vaccine has been tested in clinical trials and shown to be well tolerated and immunogenic, inducing bactericidal antibodies in infants, adolescents and adults. The high level of genetic and antigenic variability observed in MenB clinical isolates, requires a suitable method to assess the ability of the 4CMenB vaccine to cover genetically diverse menigococcal strains and to estimate the potential public health impact. To this purpose the Meningococcal Antigen Typing System (MATS) has been developed and recently described. This method provides a quick and reproducible tool to estimate the level of expression and immunoreactivity of each of the vaccine antigens, in any meningococcal isolate, and it is related to the likelihood that the isolate will be killed by sera from immunized subjects. A multi-laboratory study involving several European countries, demonstrates that the 4CMenB has the potential to protect against a significant proportion of menB strains circulating in Europe.
SourceAvailable from: Daniela Amicizia[Show abstract] [Hide abstract]
ABSTRACT: Since the development of the first-generation vaccines based on outer membrane vesicles (OMV), which were able to contain strain-specific epidemics, but were not suitable for universal use, enormous steps forward in the prevention of Neisseria meningitidis B have been made. The first multicomponent vaccine, Bexsero(®), has recently been authorized for use; other vaccines, bivalent rLP2086 and next-generation OMV vaccines, are under development. The new vaccines may substantially contribute to reducing invasive bacterial infections as they could cover most Neisseria meningitidis B strains. Moreover, other potentially effective serogroup B vaccine candidates are being studied in preclinical settings. It is therefore appropriate to review what has recently been achieved in the prevention of disease caused by serogroup B.Expert Review of Vaccines 01/2014; DOI:10.1586/14760584.2014.880341 · 4.22 Impact Factor
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ABSTRACT: Invasive disease caused by Neisseria meningitidis is associated with high mortality and high disability rates and mainly affects children under one year of age. Vaccination is the best way to prevent meningococcal disease, especially in infants and toddlers. The introduction of massive meningococcal serogroup C vaccination has drastically reduced the incidence of disease caused by this serogroup, and serogroup B has now become the main causative agent in several industrialized countries. The first serogroup B vaccines, which were used for more than two decades, were based on outer membrane vesicles and proved to be protective only against specific epidemic strains in Cuba, Norway, Brazil and New Zealand. Moreover, these often elicited a scant immune response in young children. Innovative genomics-based reverse vaccinology subsequently enabled researchers to identify genes encoding for surface proteins that are able to elicit a strong immune response against several B strains. This important discovery led to the development and recent approval in Europe of the four-component meningococcal serogroup B (4CMenB) vaccine. Large clinical trials have shown high immunogenicity and tolerability and acceptable safety levels of 4CMenB in infants and toddlers. This vaccine is expected to cover a large number of circulating invasive strains and may also be efficacious against other serogroups. Young children are particularly vulnerable to the devastating consequences of meningococcal disease. Given the high performance of 4CMenB and its non-interference with routine vaccinations, this age-group will be the first to benefit from the introduction of this vaccine.The Indian Journal of Medical Research 12/2013; 138(6):835-46. · 1.66 Impact Factor
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ABSTRACT: The first meningococcal vaccine with the potential to provide broad coverage against serogroup B disease has recently been approved for use in Europe. This vaccine, multi-component serogroup B vaccine (4CMenB), contains recombinant proteins and outer membrane vesicles, and has been extensively studied in clinical trials involving over 7500 adults, children and infants. As well as demonstrating immunogenicity against a range of serogroup B meningococcal strains, these trials have also demonstrated relatively high rates of fever following infant immunization. This article will summarize the vaccine composition, clinical trials and suggested schedules of this vaccine, with specific attention to immunogenicity, reactogenicity, safety, potential coverage and optimal implementation of this vaccine.Expert Review of Vaccines 08/2013; 12(8):837-58. DOI:10.1586/14760584.2013.814862 · 4.22 Impact Factor