Table 1.
4CMenB Vaccine | rLP2086 Vaccine | |
---|---|---|
Age | From 6 to 8 weeks | From 10 years |
Posology |
|
|
Cross-protection | In vitro: The genes encoding for the antigens fHbp, NHBA, and NadA can be present and expressed in other serogroups, suggesting a potential impact of MenB vaccines against non-B strains Clinical: Neisseria gonorrhea |
In vitro: The genes encoding for fHbp antigen can be present and expressed in other serogroups, suggesting a potential impact of MenB vaccines against non-B strains Clinical: unknown |
Number of components/antigens | 4 different components/antigens
|
2 components, variants of 1 single antigen
|
Nasopharyngeal impact | ± Preliminary data | No data available |
Duration of protection | Immune persistence data 7,5 years79 |
Immune persistence data – 4−5 years109 |
Special groups | Complement deficiencies, asplenia, splenic dysfunction, and those receiving eculizumab | No data available |
Effectiveness |
|
No data available |
Strain coverage prediction | MATS assess if strain expressed antigens are recognized by the vaccine induced antibodies (basing on the variant and quantity of expressed antigen),
|
MEASURE assess level of expressed antigen regardless of if the antigen is or not recognized by the vaccine induced antibodies (in 2.150 strains from EU, US, and Canada, 91% of the strains expressed sufficient levels of fHbp susceptible to bactericidal activity by vaccine antibodies) |
Bactericidal activity | Serum bactericidal antibodies were measured with hSBA assays using 3 strains selected to measure responses to fHbp, NadA, or PorA. Proportion of subjects who achieved a 4-fold or greater increase in hSBA titer for each of the 3 strains was 88% against representative strains in the UK (higher estimation than with MATS) |
The vaccine was then tested for hSBA against the representative strains of different fHbp type, (PMB3302 (A04), PMB1256 (B03), PMB2001 (A56), PMB2707 (B44), PMB1321 (A22), and PMB2948 (B24). Proportion of subjects who achieved hSBA titers >1:8–16 (depending on the strain) was 80% against different representative strains |
Antigenic expression | % invasive strains expressing each vaccine antigen at levels that predict bactericidal activity
|
>96% of the MenB strains in Europe express fHbp A o B (2 variants A 30% and B 70%) |
Presence of the gene | >99% of the invasive strains of Men B contains genes from at least 1 component of 4CMenB | >99% of the invasive strains of Men B contains genes from at least 1 component of rLP2806 |