Dose-response to type V group B streptococcal polysaccharide-tetanus toxoid conjugate vaccine in healthy adults.

A phase 1, dose-escalating trial was conducted in healthy adults to evaluate immunogenicity and reactogenicity of a type V group B streptococcal (GBS) capsular polysaccharide (CPS)-tetanus toxoid (TT) conjugate vaccine. Participants received one dose of unconjugated V CPS (37 microg), V-TT (2.4 microg CPS/1.1 microg TT), V-TT (9.6 microg CPS/4.3 microg TT) or V-TT (38.5 microg CPS/17.0 microg TT). Each vaccine and all doses of V-TT were well-tolerated. V CPS-specific antibodies reached a peak 4-8 weeks after immunization and were significantly higher through 52 weeks post-immunization in recipients of V-TT at each dose than in uncoupled CPS vaccinees. V-TT vaccine-induced antibodies promoted opsonophagocytic killing of type V GBS and avidity maturation of V CPS-specific IgG.