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Carol J. Baker, Lawrence C. Paoletti, Marcia A. Rench, Hilde-Kari Guttormsen, Morven S. Edwards, Dennis L. Kasper, Immune Response of Healthy Women to 2 Different Group B Streptococcal Type V Capsular Polysaccharide-Protein Conjugate Vaccines, The Journal of Infectious Diseases, Volume 189, Issue 6, 15 March 2004, Pages 1103–1112, https://doi.org/10.1086/382193
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Abstract
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 (CRM197) 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 ⩾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.