Block Stan L, Reisinger Keith S, Hultquist Micki, Walker Robert E
Kentucky Pediatric Research, 201 S. 5th St., Bardstown, KY 40004-1142, USA.
Antimicrob Agents Chemother. 2007 Nov;51(11):4001-8. doi: 10.1128/AAC.00517-07. Epub 2007 Aug 27.
The frozen version of live attenuated influenza vaccine (LAIV; FluMist) was compared with a newly licensed, refrigerated formulation, the cold-adapted influenza vaccine, trivalent (CAIV-T), for their immunogenicity, safety, and tolerability in healthy subjects 5 to 49 years of age. Eligible subjects were randomized 1:1 to receive CAIV-T or frozen LAIV. Subjects 5 to 8 years of age received two doses of vaccine 46 to 60 days apart; subjects 9 to 49 years of age received one dose of vaccine. Equivalent immunogenicities were defined as serum hemagglutination inhibition (HAI) geometric mean titer (GMT) ratios >0.5 and <2.0 for each of the three vaccine-specific strains. A total of 376 subjects 5 to 8 years of age and 566 subjects 9 to 49 years of age were evaluable. Postvaccination HAI GMT ratios were equivalent for CAIV-T and LAIV. The GMT ratios of CAIV-T/LAIV for the H1N1, H3N2, and B strains were 1.24, 1.02, and 1.00, respectively, for the 5- to 8-year-old age group and 1.14, 1.12, and 0.96, respectively, for the 9- to 49-year-old age group. Seroresponse/seroconversion rates (fourfold or greater rise) were similar in both age groups for each of the three vaccine strains. Within 28 days, the most frequent reactogenicity event in the CAIV-T and LAIV groups was runny nose/nasal congestion, which occurred at higher rates after dose 1 (44% and 42%, respectively) than after dose 2 (41% and 29%, respectively) in the 5- to 8-year-old group. Otherwise, the rates of adverse events (AEs) were similar between the treatment groups and the two age cohorts, with no serious AEs related to the study vaccines. The immunogenicities, reactogenicity events, and AEs were comparable for refrigerated CAIV-T and frozen LAIV.
将减毒活流感疫苗（LAIV；FluMist）的冻干剂型与新获批的冷藏剂型——三价冷适应流感疫苗（CAIV-T），就其在5至49岁健康受试者中的免疫原性、安全性和耐受性进行了比较。符合条件的受试者按1:1随机分组，分别接受CAIV-T或冻干LAIV。5至8岁的受试者间隔46至60天接种两剂疫苗；9至49岁的受试者接种一剂疫苗。对于三种疫苗特异性毒株中的每一种，等效免疫原性定义为血清血凝抑制（HAI）几何平均滴度（GMT）比值>0.5且<2.0。共有376名5至8岁的受试者和566名9至49岁的受试者可纳入评估。CAIV-T和LAIV接种后的HAI GMT比值相当。5至8岁年龄组中，H1N1、H3N2和B毒株的CAIV-T/LAIV的GMT比值分别为1.24、1.02和1.00；9至49岁年龄组中，这三种毒株的GMT比值分别为1.14、1.12和0.96。在两个年龄组中，三种疫苗毒株各自的血清反应/血清转化率（四倍或更高的升高）相似。在28天内，CAIV-T组和LAIV组中最常见的反应原性事件是流鼻涕/鼻塞，在5至8岁组中，第1剂后出现的发生率（分别为44%和42%）高于第2剂后（分别为41%和29%）。除此之外，治疗组与两个年龄队列之间的不良事件（AE）发生率相似，没有与研究疫苗相关的严重AE。冷藏的CAIV-T和冻干的LAIV在免疫原性、反应原性事件和AE方面具有可比性。
