Immune Response of Healthy Women to 2 Different Group B Streptococcal Type V Capsular Polysaccharide-Protein Conjugate Vaccines

• Published in: The Journal of infectious diseases Vol. 189; no. 6; pp. 1103 - 1112
• Main Authors: Baker, Carol J., Paoletti, Lawrence C., Rench, Marcia A., Guttormsen, Hilde-Kari, Edwards, Morven S., Kasper, Dennis L.
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 15.03.2004; University of Chicago Press; Oxford University Press
• Subjects: Adolescent; Adult; Antibodies; Antibodies, Bacterial - blood; Applied microbiology; Bacteria; Bacterial Capsules - immunology; Bacterial Proteins - immunology; Bacteriology; Biological and medical sciences; Conjugate vaccines; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Humans; Immune response; Immunization; Immunoglobulin G - blood; Infections; Infectious diseases; Medical sciences; Microbiology; Middle Aged; Miscellaneous; Older adults; Placebos; Polysaccharides; Streptococcal Vaccines - immunology; Streptococcus; Streptococcus agalactiae; Streptococcus agalactiae - immunology; Tetanus Toxoid - immunology; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - immunology; Human; Immune response; Microbiology; Vaccine; Protein; Microorganism capsule; Infection; Streptococcaceae; Streptococcal infection; Streptococcus B; Bacteriosis; Bacteria; Micrococcales; Female; Polysaccharide
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/382193

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.