Use of Capsular Polysaccharide—Tetanus Toxoid Conjugate Vaccine for Type II Group B Streptococcus in Healthy Women

• Published in: The Journal of infectious diseases 2000-10, Vol.182 (4), p.1129-1138
• Main Authors: Baker, Carol J., Paoletti, Lawrence C., Rench, Marcia A., Guttormsen, Hilde-Kari, Carey, Vincent J., Hickman, Melissa E., Kasper, Dennis L.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antibodies; Antibodies, Bacterial - blood; Antibody Formation; Bacterial Capsules; Bacterial Vaccines - therapeutic use; Bacteriology; Biological and medical sciences; Conjugate vaccines; Dosage; Female; Fundamental and applied biological sciences. Psychology; Humans; Immune response; Immunization; Immunoglobulin G - blood; Infections; Major Articles; Microbiology; Middle Aged; Oxidation; Polysaccharides; Polysaccharides, Bacterial - adverse effects; Polysaccharides, Bacterial - immunology; Polysaccharides, Bacterial - metabolism; Polysaccharides, Bacterial - therapeutic use; Streptococcal Infections - immunology; Streptococcal Infections - prevention & control; Streptococcus agalactiae; Streptococcus agalactiae - immunology; Tetanus toxin; Tetanus Toxoid - adverse effects; Tetanus Toxoid - metabolism; Tetanus Toxoid - therapeutic use; Vaccination; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies; Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - therapeutic use
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1086/315839

An estimated 15% of invasive group B streptococcal (GBS) disease is caused by type II capsular polysaccharide (II CPS). In developing a pentavalent vaccine for the prevention of GBS infections, individual GBS CPSs have been coupled to tetanus toxoid (TT) to prepare vaccines with enhanced immunogenicity. Type II GBS (GBS II) vaccine was created by direct, covalent coupling of II CPS to TT by reductive amination. In 2 clinical trials, 75 healthy nonpregnant women 18–45 years old were randomized to receive IICPS-TT (II-TT) conjugate (dose range, 3.6–57 µg of CPS component) or uncoupled II CPS vaccine. Both vaccines were well tolerated. II CPS—specific IgG serum concentrations (as well as IgM and IgA) peaked 2 weeks after immunization, being significantly higher in recipients of conjugated vaccine than in recipients of uncoupled CPS. Immunological responses to conjugate were dose dependent and correlated with opsonophagocytosis in vitro. These results support inclusion of II-TT conjugate when preparing a multivalent GBS vaccine.