MacIntyre C Raina, Egerton Tony, McCaughey Malcolm, Parrino Janie, Campbell Bernadette V, Su Shu-Chih, Pagnoni Marco F, Stek Jon E, Xu Jin, Annunziato Paula W, Chan Ivan S F, Silber Jeffrey L
University of New South Wales, Sydney, Australia.
Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.
This study evaluated safety & immunogenicity of ZOSTAVAX® (zoster vaccine: ZV) administered concomitantly versus nonconcomitantly with PNEUMOVAX® 23 (pneumococcal vaccine: PPV23). This randomized, double-blind, placebo-controlled study enrolled 473 subjects ≥60 years old in 1:1 ratio to receive ZV & PPV23 concomitantly (Day 1) or nonconcomitantly (PPV23 Day 1, ZV Week 4). Blood samples obtained for pneumococcal polysaccharide (PnPs) antibody (Ab) testing by enzyme-linked immunosorbent assay (ELISA) and varicella-zoster virus (VZV) Ab testing by glycoprotein ELISA. Subjects followed for adverse experiences (AEs) for 28 days postvaccination. Mean baseline VZV geometric mean titers (GMT) in nonconcomitant group were lower than concomitant group. Four weeks postvaccination with ZV, VZV Ab response in concomitant group was not similar to nonconcomitant group; estimated VZV GMT ratio [concomitant/nonconcomitant] was 0.70 (95% CI, 0.61-0.80). VZV Ab response was acceptable in concomitant group; estimated geometric mean foldrise (GMFR) from baseline was 1.9 (95% CI, 1.7-2.1). PnPs serotype-specific Ab responses were similar in both groups. All 6 reported serious AEs were deemed not related to study vaccine. Postvaccination of ZV, incidence of injection-site AEs was similar in both groups; clinical AEs were numerically but not significantly higher in nonconcomitant group. In summary, VZV GMT Ab response induced by ZV administered concomitantly with PPV23 was inferior to that induced nonconcomitantly. These results indicate that, to avoid a potential decrease in ZV immunogenicity, ZV & PPV23 should not be given concomitantly. Concomitant administration did not affect response to PPV23 serotypes tested. When administered concomitantly, ZV & PPV23 vaccines were generally well tolerated.
本研究评估了ZOSTAVAX®(带状疱疹疫苗:ZV)与PNEUMOVAX® 23(肺炎球菌疫苗:PPV23)同时接种和不同时接种的安全性和免疫原性。这项随机、双盲、安慰剂对照研究按1:1的比例招募了473名60岁及以上的受试者,分别接受ZV和PPV23同时接种(第1天)或不同时接种(PPV23第1天,ZV第4周)。通过酶联免疫吸附测定(ELISA)获取血样进行肺炎球菌多糖(PnPs)抗体(Ab)检测,并通过糖蛋白ELISA进行水痘带状疱疹病毒(VZV)Ab检测。对受试者接种疫苗后28天的不良事件(AE)进行随访。不同时接种组的平均基线VZV几何平均滴度(GMT)低于同时接种组。接种ZV四周后,同时接种组的VZV抗体反应与不同时接种组不同;估计的VZV GMT比值[同时接种组/不同时接种组]为0.70(95%CI,0.61 - 0.80)。同时接种组的VZV抗体反应是可接受的;从基线估计的几何平均上升倍数(GMFR)为1.9(95%CI,1.7 - 2.1)。两组的PnPs血清型特异性抗体反应相似。报告的6例严重AE均被认为与研究疫苗无关。接种ZV后,两组注射部位AE的发生率相似;非同时接种组的临床AE在数值上略高,但无显著差异。总之,ZV与PPV23同时接种诱导的VZV GMT抗体反应低于不同时接种诱导的反应。这些结果表明,为避免ZV免疫原性的潜在降低,ZV和PPV23不应同时接种。同时接种不影响对所检测的PPV23血清型的反应。同时接种时,ZV和PPV23疫苗总体耐受性良好。