HIV感染成人对13价肺炎球菌结合疫苗与23价多糖疫苗的长期血清学反应
Long-Term Serological Response to 13-Valent Pneumococcal Conjugate Vaccine Versus 23-Valent Polysaccharide Vaccine in HIV-Infected Adults.
作者信息
Belmonti Simone, Rossetti Barbara, Modica Sara, Paglicci Lorenzo, Borghetti Alberto, Ciccullo Arturo, Picarelli Chiara, Cauda Roberto, De Luca Andrea, Montagnani Francesca, Lombardi Francesca
机构信息
Istituto di Clinica Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy.
Hospital Department of Specialized and Internal Medicine, University Division of Infectious Diseases, Viale Bracci 16, 53100, Siena, Italy.
出版信息
Infect Dis Ther. 2019 Sep;8(3):453-462. doi: 10.1007/s40121-019-0256-z. Epub 2019 Jul 30.
INTRODUCTION
Long-term comparative immunologic response to 13-valent pneumococcal conjugate vaccine (PCV13) versus 23-valent polysaccharide vaccine (PPV23) among HIV-infected adults has not yet been investigated.
METHODS
In this prospective pilot study, we quantified in HIV-positive adults serotype-specific IgG concentrations of the 12 pneumococcal serotypes shared by both vaccines 5 years after vaccination with two doses of PCV13 8 weeks apart (group 1) or one dose of PPV23 (group 2) and compared them with those assessed prior to vaccination (BL) and after 1 year (T1). Comparison of immunogenicity was based on geometric mean concentration (GMC), proportion of individuals with ≥ twofold increase from BL in specific antibody concentration against ≥ 2 serotypes and percentage of individuals with serotype-specific IgG ≥ 0.35 μg/ml, ≥ 1 μg/ml and ≥ individual serotype-specific correlates of protection.
RESULTS
We included 91 subjects (median CD4 650 cells/µl, > 90% with HIV-RNA < 50 copies/ml); patients in groups 1 (n = 42) and 2 (n = 49) were homogeneous for the main characteristics. GMCs were significantly higher in the PCV13 group than in the PPV23 group for serotype 19F (p = 0.003). Both vaccines revealed higher significant GMCs to most serotypes compared with BL, i.e., eight in group 1 vs. seven in group 2. With respect to T1, GMCs decreased significantly in the PCV13 group for eight vs. ten serotypes in the PPV23 group. More participants in the PCV13 group had ≥ 2 increase from BL in antibody levels to ≥ 2 serotypes compared with the PPV23 group (78.6% vs. 59.2%, p = 0.042). Overall, the percentage of subjects with serotype-specific IgG ≥ 0.35 μg/ml, ≥ 1 μg/ml and ≥ individual serotype-specific correlates of protection was similar between groups.
CONCLUSION
In this study with HIV-positive adults with a favorable viro-immunologic profile, both vaccines were shown to achieve a long-term durable serologic response. We found minor differences in immunogenicity between the two vaccines, which favored PCV13 over PPV23 5 years after immunization.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT02123433.
引言
尚未对HIV感染成人中13价肺炎球菌结合疫苗（PCV13）与23价多糖疫苗（PPV23）的长期免疫反应进行比较研究。
方法
在这项前瞻性试点研究中，我们对HIV阳性成人在分别间隔8周接种两剂PCV13（第1组）或一剂PPV23（第2组）疫苗5年后，对两种疫苗共有的12种肺炎球菌血清型的血清型特异性IgG浓度进行了定量，并将其与接种疫苗前（基线）和1年后（T1）评估的浓度进行比较。免疫原性的比较基于几何平均浓度（GMC）、针对≥2种血清型的特异性抗体浓度较基线增加≥两倍的个体比例，以及血清型特异性IgG≥0.35μg/ml、≥1μg/ml和≥个体血清型特异性保护相关性的个体百分比。
结果
我们纳入了91名受试者（CD4中位数为650个细胞/μl，>90%的HIV-RNA<50拷贝/ml）；第1组（n = 42）和第2组（n = 49）的患者主要特征相似。PCV13组中19F血清型的GMC显著高于PPV23组（p = 0.003）。与基线相比，两种疫苗对大多数血清型的GMC均显著升高，第1组为8种，第2组为7种。关于T1，PCV13组中8种血清型的GMC显著下降，而PPV23组为10种。与PPV23组相比，PCV13组中更多参与者针对≥2种血清型的抗体水平较基线增加≥两倍（78.6%对59.2%，p = 0.042）。总体而言，两组中血清型特异性IgG≥0.35μg/ml、≥1μg/ml和≥个体血清型特异性保护相关性的受试者百分比相似。
结论
在这项针对病毒免疫状况良好的HIV阳性成人的研究中，两种疫苗均显示出长期持久的血清学反应。我们发现两种疫苗在免疫原性上存在细微差异，免疫接种5年后PCV13优于PPV23。
试验注册
ClinicalTrials.gov标识符，NCT02123433。
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