Systematic review of the clinical development of group B streptococcus serotype-specific capsular polysaccharide-based vaccines.

INTRODUCTION: Vaccination against group B Streptococcus (GBS) during pregnancy could provide protection against disease in the mother, fetus, and newborn. Immunity through transplacental acquired antibodies in the newborns could persist through early infancy, reducing the risk of early-onset (<7 days age) and late-onset (7-89 days age) disease. We conducted a systematic review of clinical trials on GBS capsular polysaccharide (CPS) vaccine to assess its safety and immunogenicity in pregnant and nonpregnant adults. AREAS COVERED: We searched literature databases PubMed (Medline), Scopus, and the Cochrane library and identified 25 unique records on GBS CPS vaccines with or without conjugant protein. EXPERT COMMENTARY: GBS vaccines were well tolerated, with mild local reactogenicity being the main solicited adverse event and no difference in reporting of other serious adverse events compared to placebo recipients. CPS vaccines conjugated to immunogenic proteins induced ≥fourfold increase of serotype-specific antibodies with high longevity (1-2 years); and capable of promoting homotypic GBS opsonophagocytic killing. Feto-maternal transplacental antibody ratio of serotype-specific IgG ranged between 0.49 and 0.81. The clinical relevance of these immunogenicity studies, however, need to be weighed against a correlate of protection against invasive GBS disease in infants, which is yet to be established using a universally accepted standardized assay.