Lesprit Philippe, Pédrono Gaëlle, Molina Jean-Michel, Goujard Cécile, Girard Pierre-Marie, Sarrazin Nathalie, Katlama Christine, Yéni Patrick, Morineau Pascale, Delfraissy Jean-François, Chêne Geneviève, Lévy Yves
Henri Mondor Hospital, Créteil, France bINSERM U593, Bordeaux, France.
AIDS. 2007 Nov 30;21(18):2425-34. doi: 10.1097/QAD.0b013e3282887e91.
To evaluate whether a strategy combining a prime with a 7-valent conjugate pneumococcal vaccine (PCV) followed by a boost with the 23-valent polysaccharide vaccine (PPV) would improve immunogenicity against Streptococcus pneumoniae polysaccharides in HIV-infected patients.
Randomized controlled phase II trial.
Two-hundred and twelve patients with CD4 cell counts of 200-500 cells/mul and HIV RNA< 4 log10 copies/ml, regardless of antiretroviral treatment, were randomized to receive either PCV at week 0 and PPV at week 4 (n = 106) or PPV alone at week 4 (n = 106). The proportion of responders to 0, 1-2, 3-4, 5-7 serotypes shared by the two vaccines was evaluated at week 8 and compared using a proportional odds model allowing for adjustment for CD4 cell count, HIV RNA and antiretroviral treatment.
At week 8, the profile of response was better in the prime-boost group compared to the PPV group, as determined by the frequency of patients who reached both a twofold increase of serotype-specific IgG levels and IgG level >/= 1 mug/ml [proportional odds ratio (OR), 2.09; 95% confidence interval (CI), 1.25-3.51; P = 0.005]. No differences in responders were found 4 weeks after PCV or PPV alone, suggesting that PCV primed for response to PPV. Early differences between groups remained significant at week 24 (proportional OR, 2.14; 95% CI, 1.30-3.54; P = 0.003).
In a setting of practical care, a PCV prime-PPV boost strategy enhances the frequency, breadth and magnitude of antibody responses against SPP in HIV-infected adults.
评估先用7价结合肺炎球菌疫苗(PCV)进行初次免疫,随后用23价多糖疫苗(PPV)进行加强免疫的策略是否会提高HIV感染患者对肺炎链球菌多糖的免疫原性。
随机对照II期试验。
212例CD4细胞计数为200 - 500个/微升且HIV RNA < 4 log10拷贝/毫升的患者,无论其抗逆转录病毒治疗情况如何,被随机分为两组,一组在第0周接受PCV并在第4周接受PPV(n = 106),另一组在第4周单独接受PPV(n = 106)。在第8周评估对两种疫苗共有的0、1 - 2、3 - 4、5 - 7种血清型有反应者的比例,并使用允许对CD4细胞计数、HIV RNA和抗逆转录病毒治疗进行调整的比例优势模型进行比较。
在第8周时,根据血清型特异性IgG水平增加两倍且IgG水平≥1微克/毫升的患者频率判断,初次免疫 - 加强免疫组的反应情况优于PPV组[比例优势比(OR)为2.09;95%置信区间(CI)为1.25 - 3.51;P = 0.005]。单独接种PCV或PPV 4周后,有反应者未发现差异,这表明PCV为对PPV的反应做好了准备。两组之间的早期差异在第24周时仍然显著(比例OR为2.14;95%CI为1.30 - 3.54;P = 0.003)。
在实际医疗环境中,PCV初次免疫 - PPV加强免疫策略可提高HIV感染成人针对肺炎链球菌多糖的抗体反应的频率以及广度和强度。