The 4CMenB vaccine showed promise in a European randomized trial.

We currently have vaccines that protect against meningococcal serotypes A, C, W-135, and Y. However, we lack a type B meningococcal vaccine that is sufficiently antigenic, especially in infants, for whom type B disease is particularly common. In a manufacturer-funded, phase 2b open-label trial, investigators in Europe tested a new, multicomponent serogroup B meningococcal vaccine (4CMenB). In a 2:2:1:1 ratio, 1885 infants were randomized to one of four groups:

• 4CMenB plus routine vaccines at ages 2, 4, and 6 months
• 4CMenB at ages 2, 4, and 6 months; plus routine vaccines at 3, 5, and 7 months
• 4CMenB plus routine vaccines at ages 2, 3, and 4 months
• Routine vaccines alone at ages 2, 3, and 4 months

The primary outcome was a titer of 1:5 serum bactericidal activity against each of three meningococcal B strains that are specific for vaccine antigens. For two strains, all four schedules achieved the titer threshold in 99% of infants. For the third strain, adequate titers were attained in 79% to 86% of vaccinated infants, depending on the schedule. Titers for routine vaccines given concomitantly with 4CMenB were noninferior to titers for routine vaccines alone, except in response to one nonessential pertussis antigen (pertactin) and to pneumococcal serotype 6B. Fever occurred more often after administration of 4CMenB than after administration of routine vaccines.

Comment: This is the first study to show excellent immunogenicity for a vaccine against serogroup B meningococcal disease in young infants. The vaccine needs to be tested in larger, non-European populations, and optimal scheduling must be assessed. For now, these findings represent a welcome first step in preventing this often life-threatening illness.

Source:  Journal Watch Pediatrics and Adolescent Medicine