Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults
Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults
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DOI：
10.1016/s0264-410x(03)00456-0
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发表时间：
2003-10-01
期刊：
影响因子：
5.5
通讯作者：
Podda, A
中科院分区：
文献类型：
--
作者：
Frey, S;Poland, G;Podda, A
佐剂流感疫苗FLUAD（TM）由亚单位流感抗原与MF 59佐剂乳剂组合组成。该疫苗主要用于老年人群，但非老年人也可能受益。为了评估这一假设，301名健康成年人被随机分配接受两次肌肉注射FLUAD（TM）（150名受试者）或无佐剂疫苗Fluzone（TM）（151名受试者），在两项试验中以1年的间隔进行。注射由每0.5ml剂量15 μ g组成。第一次注射的疫苗组成为A/Texas/36/91（H1 N1）、A/Johannesburg/33/94（H3 N2）和B/Harbin/7/94，第二次注射的疫苗组成为A/Texas/36/91（H1 N1）、A/Nanchang/933/95（H3 N2）和B/Harbin/7/94。在免疫后28天和180天评价免疫原性。与Fluzone（TM）相比，FLUAD（TM）在健康成人中的耐受性通常良好。FLUAD（TM）与免疫后注射部位疼痛增加有关。在第一次注射后，FLUAD（TM）组注射部位发热、寒战、肌痛和使用镇痛药/解热药的发生率在统计学上显著增加，但在第二次注射后没有增加。在两组中，大多数局部和全身反应被归类为轻度。在两种注射后，FLUAD（TM）比Fluzone TM更具免疫原性。首次注射后，在B抗原免疫后28天，血凝素抑制（III）滴度升高4倍的受试者百分比存在统计学显著差异。在第二次注射后，FLUADTM组具有显著更高的HI滴度，滴度增加4倍的显著更高的百分比，以及在28天时H3 N2抗原滴度大于或等于160的显著更高百分比的受试者。在180天时，两组之间仅观察到轻微的免疫原性差异。与Fluzone（TM）相比，FLUAD（TM）与健康成人的免疫原性增加和轻度免疫后反应有关。健康成人中免疫原性增加的幅度小于老年人群中观察到的幅度。(C)2003 Elsevier Ltd.保留所有权利。
The adjuvanted influenza vaccine FLUAD(TM) is composed of subunit influenza antigens combined with the MF59-adjuvant emulsion. The vaccine was developed primarily for use in elderly populations, but non-elderly individuals might also benefit. To evaluate this hypothesis, 301 healthy adults were assigned randomly to receive two intramuscular injections of either FLUAD(TM) (150 subjects) or a non-adjuvanted vaccine, Fluzone(TM) (151 subjects), in two trials conducted at a 1-year interval. Injections consisted of 15 mug per 0.5 ml dose. Vaccine composition was A/Texas/36/91 (H1N1), A/Johannesburg/33/94 (H3N2), and B/Harbin/7/94 for the first injection and A/Texas/36/91 (H1N1), A/Nanchang/933/95 (H3N2), and B/Harbin/7/94 for the second injection. Immunogenicity was evaluated at 28 and 180 days post-immunization. FLUAD(TM) was generally well tolerated in healthy adults when compared with Fluzone(TM). FLUAD(TM) was associated with increased pain at the injection site after immunization. A statistically significant increase in the incidence of injection-site warmth, chills, myalgia, and analgesic/antipyretic use occurred in the FLUAD(TM) group after the first injection but not after the second injection. In both groups, most of these local and systemic reactions were classified as mild. FLUAD(TM) was more immunogenic than Fluzone TM following both injections. After the first injection, statistically significant differences were found in the percentage of subjects with four-fold rises in hemagglutinin inhibition (III) titers at 28 days post-immunization for the B antigen. After the second injection, the FLUADTM group had significantly higher HI titers, a significantly higher percentage with a four-fold increase in titer, and a significantly greater percentage of subjects with titers greater than or equal to 160 for the H3N2 antigen at 28 days. Only minor immunogenicity differences between the two groups were seen at 180 days. Compared with Fluzone(TM), FLUAD(TM) was associated with increased immunogenicity and mild post-immunization reactions in healthy adults. The magnitude of increased immunogenicity in healthy adults was less than that seen in elderly populations. (C) 2003 Elsevier Ltd. All rights reserved.