Clinical Data

Clinical and Immunogenicity Data of Pneumococcal Vaccines in Renal Diseases

As compared with the general population, increased mortality and morbidity from pneumococcal disease is observed in patients with CKD; the mortality rates being up to 10 to 16 times higher in patients undergoing dialysis. These patients are at a high risk of developing pneumococcal disease, and are also at a risk of vaccine hyporesponsiveness.¹ There is scarcity of data on the efficacy of pneumococcal vaccines in patients with ESRD.² Evidence indicates lowered immunologic response of patients with dialysis towards PPSV23, as compared with the general population. The anti-pneumococcal IgG levels decline rapidly in patients with ESRD 1 year after receiving PPSV23. A study evaluated the immunogenicity of PCV13 in 17 patients with ESRD who were on dialysis.² The overall response to the individual vaccine serotypes ranged between 23.5% and 94.1% at 2 months, and 23.5% and 65% at 12 months post PCV13 administration. The study demonstrated that at 2 months post vaccination, PCV13 elicited good antibody response in dialysis patients. However, the response decreased 12 months post vaccination.¹

A longitudinal quasi-experimental Phase IV study assessed the immunogenicity of PCV13 versus PPSV23 in 155 haemodialysis patients aged ≥50 years, with or without prior PPSV23 vaccination. Significant immune response was observed for at least 1 year after PCV13 and PPSV23 vaccination in patients who were not previously vaccinated with PPSV23. PCV13 was more immunogenic than PPSV23 in vaccine-naïve haemodialysis patients. Moreover, as compared with vaccine-naïve haemodialysis patients, PCV13 elicits weaker immune response in PPSV23 pre-vaccinated patients. Although the trial was not designed to draw conclusion on mortality, vaccine-naïve patients administered with PCV13 tended to have lower mortality than the other groups studied.²

CKD, chronic kidney disease; ESRD, end-stage renal disease; IgG, immunoglobulin G; PCV13, 13-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal plain polysaccharide vaccine.

References: