Journal Article

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Prime-Boost Strategy for Pneumococcal Vaccination in Adult Liver Transplant Recipients

Deepali Kumar, Maggie Hong Chen, Gary Wong, Isabel Cobos, Brenda Welsh, Deborah Siegal and Atul Humar

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 47, issue 7, pages 885-892
Published in print October 2008 | ISSN: 1058-4838
Published online October 2008 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/591537
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Prime-Boost Strategy for Pneumococcal Vaccination in Adult Liver Transplant Recipients

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  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

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Background. The 23-valent pneumococcal polysaccharide vaccine (PPV23) is recommended for disease prevention in solid-organ transplant recipients, but it may have suboptimal immunogenicity. It may be possible to enhance immunogenicity by priming the recipient with the 7-valent pneumococcal conjugate vaccine (PCV7), followed by boosting with PPV23.

Methods. We randomized adult liver transplant recipients to receive either (1) PCV7 followed by a PPV23 booster 8 weeks later (the “primed” group) or (2) placebo followed by a standard single dose of PPV23 (the “unprimed” group). Quantitative and functional antibody titers for 7 serotypes contained in both vaccines were measured at baseline, 8 weeks after enrollment, and 16 weeks after enrollment. Of 130 randomized patients, 113 completed the study.

Results. At week 16, response to at least 1 serotype was seen in 48 (85.7%) of 56 and 52 (91.2%) of 57 patients for the primed and unprimed groups, respectively (P=not significant). The mean number of serotypes to have responded (±SD) was 3.7±2.3 and 4.4±2.2 for the primed and unprimed groups, respectively (P=not significant). Functional antibody titers, which were measured with use of the opsonophagocytic assay, were also similar in both groups.

Conclusions. The immunogenicity of pneumococcal vaccination was not enhanced by the prime-boost strategy, compared with vaccination with PPV23 alone. Administration of a single dose of PPV23 should continue to be the standard of care for adult liver transplant recipients.

Clinical trials registration. NCT00152802 (http://www.clinicaltrials.gov).

Journal Article.  3686 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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