Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial

This study (n=365) found the novel vaccine was well tolerated and elicited robust immune responses that persisted for 6 months, supporting further evaluation in pregnant women as a potential strategy for prevention of invasive disease in young infants.

SPS commentary:

The novel vaccine is directed against six capsular polysaccharide serotypes of group B streptococcus (GBS; Ia, Ib, II, III, IV, and V) that account for the vast majority of isolates causing invasive GBS disease worldwide. A related Comment notes that several phase 1 and 2 studies of GBS vaccines have been conducted, with promising results, but the next steps that are urgently needed are often not taken. Efficacy studies would require large numbers of immunised mothers because of the low incidence of neonatal GBS disease; it has therefore been proposed that alternative options to vaccine licensure be explored. 


The Lancet Infectious Diseases

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