Randomized, single blind, controlled trial to evaluate the prime-boost strategy for pneumococcal vaccination in renal transplant recipients

PLoS One. 2012;7(9):e46133. doi: 10.1371/journal.pone.0046133. Epub 2012 Sep 28.

Abstract

Renal transplant recipients are at increased risk of developing invasive pneumococcal diseases but may have poor response to the 23-valent pneumococcal polysaccharide vaccine (PPV). It may be possible to enhance immunogenicity by priming with 7-valent pneumococcal conjugate vaccine (7vPnC) and boosting with PPV 1 year later. In a randomized single-blind, controlled study, adult recipients of renal transplants received either 7nPVC or PPV followed by PPV 1 year later. The vaccine response was defined as 2-fold increase in antibody concentration from baseline and an absolute post-vaccination values ≥1 µg/ml. The primary endpoint was vaccine response of the primed group (7vPnC/PPV) compared with single PPV vaccination. Antibody concentrations for 10 serotypes were measured at baseline, 8 weeks after first vaccination, before second vaccination, and 8 weeks after second vaccination. Of 320 screened patients, 80 patients were randomized and 62 completed the study. Revaccination with PPV achieved no significant increase of immune response in the 7vPnC/PPV group compared with the single PPV recipients A response to at least 1 serotype was seen in 77.1% of patients who received 7vPnC and 93.1% of patients who received PPV (P = 0.046). After second vaccination response to at least 1 serotype was seen in 87.5% patients of 7vPnC/PPV group and 87.1% patients of PPV group (non significant p). The median number of serotypes eliciting a response was 3.5 (95% CI 2.5-4.5) in the 7vPnC/PPV group versus 5 (95% CI 3.9-6.1) in the PPV group (non-significant p). Immunogenicity of pneumococcal vaccination was not enhanced by the prime-boost strategy compared with vaccination with PPV alone. Administration of a single dose of PPV should continue to be the standard of care for adult recipients of renal transplants.

Trial registration: EudraCT 2007-004590-25.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibody Formation
  • Female
  • Humans
  • Immunization, Secondary
  • Kidney Transplantation / immunology*
  • Male
  • Middle Aged
  • Pneumococcal Infections / immunology
  • Pneumococcal Infections / prevention & control*
  • Pneumococcal Vaccines / immunology
  • Pneumococcal Vaccines / therapeutic use*
  • Vaccines, Conjugate / immunology
  • Vaccines, Conjugate / therapeutic use*

Substances

  • 23-valent pneumococcal capsular polysaccharide vaccine
  • Pneumococcal Vaccines
  • Vaccines, Conjugate

Grant support

The study was funded by the Jubiläumsfonds der Österreichischen Nationalbank, grant number 13092. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.