BACKGROUND: Infections caused by group B streptococcal (GBS) type V are increasingly common. Capsular polysaccharide (CPS)-protein conjugate GBS vaccines are immunogenic in healthy adults, but type V vaccines have not previously been tested. METHODS:Thirty-five healthy, nonpregnant women were randomized to receive an intramuscular dose of GBS type V CPS-tetanus toxoid (TT) vaccine (n=15), GBS type V CPS-cross-reactive material (CRM(197)) conjugate vaccine (n=15), or placebo (n=5) (double-masked design). Levels of serum antibodies to type V CPS were measured by ELISA, and functional activity was measured by opsonophagocytosis. RESULTS: The vaccines were well tolerated. Significant increases in type V CPS-specific immunoglobulin G (IgG) were elicited by both vaccines, peaking at 4-8 weeks and persisting for 26 weeks. Four-fold or greater increases in type V CPS-specific IgG concentrations were noted in postimmunization serum samples obtained from 93% of subjects in each vaccine group. These concentrations persisted in > or =85% of conjugate-vaccine recipients 104 weeks later. Type V CPS-specific immunoglobulin M was a dominant isotype of immune response to each conjugate. Postimmunization serum samples promoted opsonophagocytic killing of GBS type V in vitro, whereas those from placebo recipients did not. CONCLUSION:GBS type V conjugate vaccines are safe and immunogenic and would be appropriate for inclusion in a candidate multivalent GBS vaccine.
RCT Entities:
BACKGROUND: Infections caused by group B streptococcal (GBS) type V are increasingly common. Capsular polysaccharide (CPS)-protein conjugate GBS vaccines are immunogenic in healthy adults, but type V vaccines have not previously been tested. METHODS: Thirty-five healthy, nonpregnant women were randomized to receive an intramuscular dose of GBS type V CPS-tetanus toxoid (TT) vaccine (n=15), GBS type V CPS-cross-reactive material (CRM(197)) conjugate vaccine (n=15), or placebo (n=5) (double-masked design). Levels of serum antibodies to type V CPS were measured by ELISA, and functional activity was measured by opsonophagocytosis. RESULTS: The vaccines were well tolerated. Significant increases in type V CPS-specific immunoglobulin G (IgG) were elicited by both vaccines, peaking at 4-8 weeks and persisting for 26 weeks. Four-fold or greater increases in type V CPS-specific IgG concentrations were noted in postimmunization serum samples obtained from 93% of subjects in each vaccine group. These concentrations persisted in > or =85% of conjugate-vaccine recipients 104 weeks later. Type V CPS-specific immunoglobulin M was a dominant isotype of immune response to each conjugate. Postimmunization serum samples promoted opsonophagocytic killing of GBS type V in vitro, whereas those from placebo recipients did not. CONCLUSION:GBS type V conjugate vaccines are safe and immunogenic and would be appropriate for inclusion in a candidate multivalent GBS vaccine.
Authors: Jenny Herbert; Stephen Thomas; Charlotte Brookes; Claudia Turner; Paul Turner; Francois Nosten; Kirsty Le Doare; Michael Hudson; Paul T Heath; Andrew Gorringe; Stephen Taylor Journal: Clin Vaccine Immunol Date: 2015-01-14
Authors: Hilde-Kari Guttormsen; Lynda M Stuart; Lei Shi; Mike C Carroll; Jianzhu Chen; Dennis L Kasper; R Alan B Ezekowitz; Kazue Takahashi Journal: Clin Immunol Date: 2008-11-08 Impact factor: 3.969
Authors: Pia S Pannaraj; Morven S Edwards; Kristen T Ewing; Amanda L Lewis; Marcia A Rench; Carol J Baker Journal: Vaccine Date: 2009-05-31 Impact factor: 3.641