Department of Infectious Diseases, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; OPEN, Open Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Nephrology, Odense University Hospital, Odense, Denmark.
Vaccine. 2022 Jun 21;40(28):3884-3892. doi: 10.1016/j.vaccine.2022.05.040. Epub 2022 May 27.
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.
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.
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.
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).
肺炎球菌疫苗序贯加强接种方案推荐用于实体器官移植受者，但该方案在该人群中的效果尚未得到充分验证。此外，尽管在健康成年人中观察到了肺炎球菌疫苗剂量效应，但尚未对此进行研究。为了评估在肾移植受者（KTR）和肾移植候补者（WLPs）中，接种一剂和两剂 13 价肺炎球菌结合疫苗（PCV13）和 23 价肺炎球菌多糖疫苗（PPV23）的序贯加强接种方案是否会提高免疫原性，进行了一项 3 期、随机、非盲临床试验。
KTR 和 WLPs 分别平行分组，间隔 12 周接种正常剂量或双倍剂量的两种疫苗。基于 12 种共有疫苗型特异性 IgG 抗体，“保护性反应”定义为平均几何平均浓度≥1mg/L。此外，还评估了抗体≥2 倍增长的数量和个体疫苗型特异性抗体浓度。随访时间为 48 周。
共纳入 74 例 KTR 和 65 例 WLPs。在 WLPs 中，与正常剂量组（35.5%）相比，PPV23 接种后 5 周，双倍剂量组（66.7%）有更高比例的参与者出现“保护性反应”，p=0.015。KTR 中未观察到剂量效应。接种 PPV23 后，所有 4 组的 2 倍以上增长的血清型数量均增加（两组 WLPs 的 p 值均≤0.05；两组 KTR 的 p 值均≤0.01）。疫苗在第 48 周仍然安全、耐受良好且具有免疫原性。
数据表明，按照序贯加强方案接种双倍剂量的肺炎球菌疫苗可能对 WLPs 是有意义的。此外，我们的数据支持 PPV23 在 KTR 和 WLPs 中与 PCV13 具有相加作用。（EudraCT：2016-004123-23）。
