Cheng Aristine, Chang Sui-Yuan, Tsai Mao-Song, Su Yi-Ching, Liu Wen-Chun, Sun Hsin-Yun, Hung Chien-Ching
Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan.
Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University College of Medicine, Taipei, Taiwan.
J Int AIDS Soc. 2016 Jan 29;19(1):20631. doi: 10.7448/IAS.19.1.20631. eCollection 2016.
HIV infection impairs maintenance of immunological memory, yet few studies of HIV-positive adults receiving 7-valent pneumococcal conjugate vaccine (PCV7) have followed them beyond the first year. We determined and compared the durability of serological responses and the clinical outcomes of HIV-positive adults annually for five years following vaccination with one or two doses of PCV7.
In this non-randomized clinical trial, 221 pneumococcal vaccine-naïve HIV-positive adults receiving one (n = 109) or two doses four weeks apart (n = 112) of PCV7 between 2008 and 2010 were longitudinally followed for evaluation of significant serological response and for episodes of pneumonia and invasive pneumococcal disease.
At the time of vaccination, the two groups were well matched for age, risk factors, combination antiretroviral therapy (cART) coverage, CD4 count and plasma HIV RNA load (PVL). At the end of five years, the CD4 counts for the one- and two-dose groups had increased from 407 and 406 to 550 and 592 cells/µL, respectively, and 82.4 and 81.6% of the participants had fully suppressed PVL. Significant immune responses to ≥ 2 serotypes persisted for 67.9 vs 78.6%, 64.2 vs 71.4%, 66.1 vs 71.4%, 57.8 vs 69.6% in the second, third, fourth and fifth years after one and two doses of PCV7 in the intention-to-treat analysis, respectively. In multivariate analysis, immunization with two doses of PCV7 (odds ratio (OR) 1.71, 95% confidence interval (CI) 1.10 to 2.65, p = 0.016), concurrent cART (OR 2.16, 95% CI 1.16 to 4.00, p = 0.015) and CD4 proliferation (OR 1.12, 95% CI 1.01 to 1.27, p = 0.031) were predictive of persistent serological responses in the fifth year. Only one patient in the one-dose group had documented pneumococcal pneumonia (non-bacteraemic) and none had invasive pneumococcal disease in the 6.5 years of follow-up.
One or two doses of PCV7 achieve durable seroprotective responses in HIV-treated participants; however, two doses may be more robust than one dose in a larger study population or in real-world populations with less cART coverage.
HIV感染会损害免疫记忆的维持，但对接受7价肺炎球菌结合疫苗（PCV7）的HIV阳性成年人进行的研究很少超过第一年。我们在接种一剂或两剂PCV7后的五年内，每年测定并比较HIV阳性成年人的血清学反应持久性和临床结局。
在这项非随机临床试验中，2008年至2010年间，221名未接种过肺炎球菌疫苗的HIV阳性成年人接受了一剂（n = 109）或两剂间隔四周的PCV7（n = 112），对其进行纵向随访，以评估显著的血清学反应以及肺炎和侵袭性肺炎球菌病的发作情况。
接种疫苗时，两组在年龄、危险因素、联合抗逆转录病毒治疗（cART）覆盖率、CD4细胞计数和血浆HIV RNA载量（PVL）方面匹配良好。五年结束时，一剂组和两剂组的CD4细胞计数分别从407和406增加到550和592个细胞/微升，82.4%和81.6%的参与者PVL得到完全抑制。在意向性分析中，一剂和两剂PCV7接种后第二年、第三年、第四年和第五年，对≥2种血清型的显著免疫反应持续率分别为67.9%对78.6%、64.2%对71.4%、66.1%对71.4%、57.8%对69.6%。在多变量分析中，接种两剂PCV7（比值比（OR）1.71，95%置信区间（CI）1.10至2.65，p = 0.016）、同时进行cART（OR 2.16，95%CI 1.16至4.00，p = 0.015）和CD4细胞增殖（OR 1.12，95%CI 1.01至1.27，p = 0.031）可预测第五年的持续血清学反应。在随访的6.5年中，一剂组只有1例记录有肺炎球菌肺炎（非菌血症型），无侵袭性肺炎球菌病病例。
一剂或两剂PCV7在接受HIV治疗的参与者中可产生持久的血清保护反应；然而，在更大的研究人群或cART覆盖率较低的现实人群中，两剂可能比一剂更有效。
