At what stage is the GSK vaccine against meningitis?
GSK is working on a single vaccine for the five most common meningococcal serogroups that cause meningitis, a disease to which children and the elderly are more vulnerable and which has a fulminant course in 10-20% of cases. All the details
Gsk's 5-in-1 vaccine candidate against five meningococcal serogroups that cause invasive meningococcal disease (IMD), a leading cause of meningitis and septicemia, met all 11 primary endpoints of the Phase III clinical trial and was well tolerated with a safety profile consistent with the same two already licensed vaccines: Bexsero (MenB) and Menveo (MenACWY).
THE BACTERIA BEHIND MENINGITIS
The bacteria that most often cause invasive bacterial diseases, says the Higher Institute of Health (ISS), are Neisseria meningitidis (meningococcus), of which there are 13 different serogroups, but only 6 cause meningitis and other serious diseases: most frequently A , B, C, W and Y and, much more rarely, especially in Africa, X.
In Italy and Europe, serogroups B and C are the most frequent cause of invasive disease, which in most cases results in meningitis and in 10-20% of cases it has a fulminant course and can lead to death in a few hours even in the presence of adequate therapy. However, one in five survivors suffer long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems.
The main cause of contagion is represented by the healthy carriers of the bacterium: only in 0.5% of cases the disease is transmitted by people affected by the disease.
GSK'S VACCINE
Gsk's vaccine candidate was administered in two doses six months apart in healthy subjects aged 10 to 25 years and met all 11 primary endpoints, including non-inferiority against all five Neisseria serogroups meningitides (A, B, C, W and Y) compared to licensed meningococcal vaccines in terms of immune response.
It was generally well tolerated, with a safety profile consistent with the same two licensed vaccines.
“These statistically significant Phase III data represent a very encouraging step towards reducing the incidence of meningococcal disease,” said Tony Wood, GSK Chief Scientific Officer.
BECAUSE IT'S 5-IN-1
Gsk's vaccine candidate (MenABCWY) combines the antigenic components of MenB and MenACWY (the two already approved vaccines) and if authorized will be the first to offer protection against the 5 most common serogroups (A, B, C, W and Y) in just one vaccine, which could lead to a simplified vaccination schedule.
Currently, in the United States, two separate vaccines requiring four injections are required to protect against all five serogroups. This immunization regimen, coupled with poor awareness of the disease, GSK reports, can lead to suboptimal immunization coverage rates, particularly for MenB, with coverage estimated at only about 31 percent of adolescents in the United States.
“In the United States, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents 16 to 18 years of age shortly before the peak incidence of this disease could have a significant impact on health public,” Wood added.
VACCINES AGAINST MENINGITIS IN ITALY
In Italy, there are three types of meningococcal vaccine: the conjugate vaccine against meningococcal serogroup C (MenC, the most frequently used and protects only against serotype C); the tetravalent conjugate vaccine (protects against serogroups A, C, W and Y); and the meningococcal type B vaccine (protects against this serogroup only).
These vaccinations are not mandatory but experts recommend them in particular to the groups most at risk, i.e. children under the first year of life and the elderly over 65, to whom the vaccine is offered free of charge.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/a-che-punto-e-il-vaccino-gsk-contro-la-meningite/ on Wed, 15 Mar 2023 14:44:36 +0000.