13价肺炎球菌结合疫苗与23价多糖疫苗在未接种疫苗的HIV感染成人中的免疫原性和安全性：一项前瞻性对照试验研究
Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.
作者信息
Lombardi Francesca, Belmonti Simone, Fabbiani Massimiliano, Morandi Matteo, Rossetti Barbara, Tordini Giacinta, Cauda Roberto, De Luca Andrea, Di Giambenedetto Simona, Montagnani Francesca
机构信息
Institute of Clinical Infectious Diseases, Catholic University of the Sacred Heart, Largo Agostino Gemelli 8, Rome, Italy.
Division of Infectious Diseases, Department of Internal Medicine, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
出版信息
PLoS One. 2016 Jun 3;11(6):e0156523. doi: 10.1371/journal.pone.0156523. eCollection 2016.
OBJECTIVES
Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13) versus the 23-valent polysaccharide vaccine (PPSV23) in HIV-infected adults.
METHODS
We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50) received two doses of PCV13 eight weeks apart, and group 2 (n = 50) received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100) were also enrolled as baseline controls.
RESULTS
Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group.
CONCLUSIONS
In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02123433.
目的
HIV 感染成人中最佳肺炎球菌疫苗策略的定义仍在评估中。我们旨在比较 13 价肺炎球菌结合疫苗（PCV13）与 23 价多糖疫苗（PPSV23）在 HIV 感染成人中的免疫原性和安全性。
方法
我们进行了一项前瞻性对照试验研究，纳入年龄在 18 - 65 岁、CD4 细胞计数≥200 个/μL 且未接种过肺炎球菌疫苗的 HIV 感染门诊患者。符合条件的受试者被招募到两个平行组：第 1 组（n = 50）接受两剂 PCV13，间隔 8 周；第 2 组（n = 50）接受一剂 PPSV23，作为其标准治疗的一部分。在基线、第 8、24 和 48 周通过 ELISA 定量抗肺炎球菌荚膜多糖免疫球蛋白 G 浓度。在相同时间点进行临床和病毒免疫学随访。未接种疫苗、年龄匹配的 HIV 阴性成人（n = 100）也作为基线对照纳入。
结果
各研究组在接种疫苗前针对每种肺炎球菌抗原的特异性 IgG 滴度无差异，但均持续低于 HIV 阴性对照组。免疫后，与基线相比，两个研究组在每个时间点的 IgG 滴度均显著升高，但第 1 组对 3 型血清型的反应减弱。在第 48 周时，各研究组针对每种抗原的抗体滴度无差异。总体而言，两组中实现对所有血清型血清保护和血清转化的受试者比例相当。两种疫苗均观察到 IgG 水平随时间显著下降。两组均未报告相关不良反应。
结论
在这个免疫状况良好的人群中，PCV13 和 PPSV23 在免疫原性方面未观察到相关差异。两种疫苗均安全且耐受性良好。
试验注册
ClinicalTrials.gov NCT02123433。
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