A randomised, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipients.
Eriksson, M., et al.Transplant Infectious Disease 2020 [record in progress]
Aims
The aim of this study was to compare the immunogenecity and safety of two vaccines in kidney transplant patients: a 23-valent pneumococcal polysaccharide vaccination (PPV23) and a repeated dose 13-valent pneumococcal conjugate vaccination (PCV13).
Interventions
Patients were randomized to either the PPV23 arm or the PCV13 arm.
Participants
133 kidney transplant candidates.
Outcomes
The primary outcome was the assessment of differences in immunogenicity between the two vaccine groups a month following the first vaccination. The secondary outcome was to determine the safety of the vaccination regimens in terms of the incidence of adverse events and serious adverse events.
Follow-up
2 months
CET Conclusions
This small single-centre study compared the use of a 23-valent pneumococcal polysaccharide vaccine (PPV23) before transplantation versus a 13-valent pneumococcal conjugate vaccine (PCV13) before transplantation and a second dose of PCV13 six months after the transplantation. The authors demonstrated greater response for a number of serotypes with the PCV13 vaccine and showed that the PCV13 vaccine demonstrated a response post-transplant. These results suggest that a strategy of vaccination with PCV13 pre-transplant, with a second dose post-transplant, is the optimum strategy. It should be noted that the study is not blinded and was relatively small, with a fairly long window to transplant in some patients. As with many vaccine studies, serological response is used as a surrogate for risk of infection.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrial.gov - NCT01781871