Safety and Immunogenicity of a Bivalent Group B Streptococcal Conjugate Vaccine for Serotypes II and III

• Published in: The Journal of infectious diseases 2003-07, Vol.188 (1), p.66-73
• Main Authors: Baker, Carol J., Rench, Marcia A., Fernandez, Marisol, Paoletti, Lawrence C., Kasper, Dennis L., Edwards, Morven S.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antibodies, Bacterial - blood; Antibodies, Bacterial - immunology; Bacteriology; Biological and medical sciences; Female; Fundamental and applied biological sciences. Psychology; Humans; immunogenicity; Immunoglobulin G - blood; Immunoglobulin G - immunology; Male; Microbiology; Middle Aged; Streptococcal Infections - immunology; Streptococcal Infections - prevention & control; Streptococcal Vaccines - adverse effects; Streptococcal Vaccines - immunology; Streptococcus; Streptococcus agalactiae - immunology; vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/375536

To determine whether 2 monovalent group B streptococcus (GBS) serotype II or III capsular polysaccharide (CPS)-tetanus toxoid (TT) conjugate vaccines combined in a single intramuscular dose would elicit immune responses comparable to those of monovalent vaccines, 75 healthy adults were randomized to receive GBS II-TT (3.6 µg of CPS), GBS III-TT (12.5 µg of CPS), or a bivalent mixture of GBS II-TT/III-TT vaccine (double-masked design). Vaccines were well tolerated. Four-fold or greater increases in GBS II or III CPS-specific IgG, respectively, were noted in postimmunization serum samples from 80%–90% of bivalent conjugate vaccine recipients, and these responses were similar to those of recipients of GBS II-TT or GBS III-TT monovalent vaccines. Immune serum samples promoted the opsonophagocytic killing of types II and III GBS in vitro. Unexpectedly, some recipients of these vaccines developed cross-reactive antibodies to the structurally similar heterologous polysaccharide. These results support the feasibility of a multivalent vaccine for the 5 prevalent invasive disease-causing GBS CPS serotypes.