Abstract
Background: Pneumococcal prime-boost vaccination is recommended for solid organ transplant recipients, but is not thoroughly tested in this population. Furthermore, a pneumococcal vaccine dose effect has never been investigated, though observed in healthy adults. To assess whether a double dose of 13-valent pneumococcal conjugate vaccine (PCV13) and of 23-valent pneumococcal polysaccharide vaccine (PPV23) increases the immunogenicity of prime-boost vaccination in kidney transplant recipients (KTRs) and patients on the kidney transplant waiting list (WLPs), a phase 3, randomized, non-blinded trial was conducted. Methods: KTRs and WLPs were in parallel groups assigned either normal or double dosage of both vaccines 12 weeks apart. A ′protective response′ was an average geometric mean concentration ≥ 1 mg/L based on 12 vaccine shared serotype-specific IgG antibodies. Furthermore, number of antibodies with ≥ 2-fold rises and individual serotype-specific antibody concentrations were evaluated. Follow-up was 48 weeks. Results: Seventy-four KTRs and 65 WLPs were enrolled. In WLPs, double dosage resulted in a significantly higher proportion of participants with a ′protective response′ (66.7%), 5 weeks after PPV23, compared to normal dosage (35.5%), p = 0.015. KTRs exhibited no dose effect. After PPV23, all four groups had increased their number of serotypes with ≥ 2-fold rises (p ≤ 0.05 for both WLPs groups; p ≤ 0.01 for both KTRs groups). Vaccines were safe, well tolerated and still immunogenic at week 48. Conclusions: Data suggests that double dosage of pneumococcal vaccines used according to the prime-boost strategy might be recommendable for WLPs. Furthermore, our data supports PPV23́s additive effect to PCV13 in KTRs and WLPs. (EudraCT: 2016–004123-23)
Originalsprog | Engelsk |
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Tidsskrift | Vaccine |
Vol/bind | 40 |
Udgave nummer | 28 |
Sider (fra-til) | 3884-3892 |
Antal sider | 9 |
ISSN | 0264-410X |
DOI | |
Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:This work was supported by grants from Region of Southern Denmark′s PhD foundation [SDUSF-2016–131]; University of Southern Denmark′s PhD foundation; Odense University Hospital [A1399]; Helen & Ejnar Bjørnows foundation [04121]; Grosserer L. F. Foghts foundation [21.262]; Aase & Ejnar Danielsen foundation [10–001896]; Juchum foundation [34599]; Foundation for “Lægevidenskabens Fremme” [16–212] and Augustinus foundation [17–0185]. No funding sources influenced the study design, data collection, data management, data analyses, or reporting.
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© 2022 The Author(s)