Concomitant administration of zoster and pneumococcal vaccines in adults ≥60 years old

被引:46
作者
MacIntyre, C. Raina [1 ]
Egerton, Tony [2 ]
McCaughey, Malcolm [3 ]
Parrino, Janie [4 ]
Campbell, Bernadette V. [4 ]
Su, Shu-Chih [4 ]
Pagnoni, Marco F. [4 ]
Stek, Jon E. [4 ]
Xu, Jin [4 ]
Annunziato, Paula W. [4 ]
Chan, Ivan S. F. [4 ]
Silber, Jeffrey L. [4 ]
机构
[1] Univ New S Wales, Sydney, NSW, Australia
[2] Priory Res, Belfast, Antrim, North Ireland
[3] Randalstown Hlth Ctr, Antrim, North Ireland
[4] Merck & Co Inc, West Point, PA USA
来源
HUMAN VACCINES | 2010年 / 6卷 / 11期
关键词
herpes zoster; zoster vaccine; pneumococcal polysaccharide vaccine; concomitant use; safety; immunogenicity; STREPTOCOCCUS-PNEUMONIAE; IMMUNOGENICITY; SAFETY; TOLERABILITY;
D O I
10.4161/hv.6.11.12852
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
This study evaluated safety & immunogenicity of ZOSTAVAX (R) (zoster vaccine: ZV) administered concomitantly versus nonconcomitantly with PNEUMOVAX (R) 23 (pneumococcal polysaccharide 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 were 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. 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. Postvaccination of ZV, clinical AEs were numerically but not significantly higher in nonconcomitant group. The incidence of injection-site AEs was similar in both groups. All 6 reported serious AEs were deemed not related to study vaccine. 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 were generally well tolerated.
引用
收藏
页码:894 / 902
页数:9
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