Safety and immunogenicity of a booster dose of Staphylococcus aureus types 5 and 8 capsular polysaccharide conjugate vaccine (StaphVAX ®) in hemodialysis patients

• Published in: Vaccine 2004-12, Vol.23 (5), p.656-663
• Main Authors: Fattom, Ali, Fuller, Steve, Propst, Myra, Winston, Scott, Muenz, Larry, He, David, Naso, Robert, Horwith, Gary
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Bacterial - blood; Applied microbiology; Bacterial Capsules - immunology; Bacteriology; Biological and medical sciences; Conjugate vaccines; Cross-Over Studies; Double-Blind Method; Enzyme-Linked Immunosorbent Assay; Female; Fundamental and applied biological sciences. Psychology; Hemodialysis; Humans; Immunization, Secondary - adverse effects; Immunoglobulin G - blood; Male; Microbiology; Middle Aged; Miscellaneous; Opsonin Proteins - analysis; Placebos; Polysaccharides, Bacterial - immunology; Pseudomonas aeruginosa; Renal Dialysis; Renal Insufficiency - therapy; Staphylococcal Infections - prevention & control; Staphylococcal Vaccines - adverse effects; Staphylococcal Vaccines - immunology; Staphylococcus aureus; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2004.06.043

StaphVAX ®, an unadjuvanted, bivalent vaccine composed of Staphylococcus aureus ( S. aureus) capsular polysaccharides (CPS) types 5 and 8 bound to the mutant non-toxic recombinant Pseudomonas aeruginosa exotoxin A (rEPA) conferred ∼60% protection for 10 months against bacteremia caused by this pathogen in hemodialysis patients. A protective level of 80 μg/ml was estimated based upon geometric mean (GM) antibody levels at the end of the efficacy period. To extend the duration of protection conferred by StaphVAX ® in hemodialysis patients, recipients of the vaccine were reinjected in a randomized double-blinded, placebo-controlled study. Vaccinees received StaphVAX ® and a saline placebo injection 14 days apart according to the randomization schedule. The booster dose of StaphVAX ® was administered an average of 958 days (753–1167 days) after the first injection. There were no serious adverse reactions. Antibody levels at day 14, 28, 92, and 182 post-injection were measured by ELISA. Maximal levels of IgG anti-CPS were observed at the 28-day interval. For type 5, GM antibody levels increased from 73 μg/ml at day 0 to 162 μg/ml ( P < 0.001) and for type 8 from 59 μg/ml to 133 μg/ml ( P < 0.001). Anti-CPS antibody levels of ∼80 μg/ml to type 5and type 8 were achieved in 72.4 and 74.3% of vaccinees, respectively. There was excellent correlation between the level of anti-CPS and opsonic titer ( r = 0.93). Moreover, the decline of anti-CPS antibody levels at six months was significantly less rapid than that observed from the first immunization ( P < 0.001). We conclude that a booster immunization to maintain protective levels of specific antibodies for an extended period of time is feasible for patients at continuous risk for S. aureus bacteremia.