CLINICAL STUDIES OF MONO-VALENT INACTIVATED WHOLE VIRUS AND SUBUNIT A-USSR-77 (H1N1) VACCINE - SEROLOGICAL RESPONSES AND CLINICAL REACTIONS
CLINICAL STUDIES OF MONO-VALENT INACTIVATED WHOLE VIRUS AND SUBUNIT A-USSR-77 (H1N1) VACCINE - SEROLOGICAL RESPONSES AND CLINICAL REACTIONS
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DOI：
10.1016/s0092-1157(79)80044-x
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发表时间：
1979-01-01
期刊：
影响因子：
--
通讯作者：
ANDERSON, SG
中科院分区：
文献类型：
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作者：
NICHOLSON, KG;TYRRELL, DAJ;ANDERSON, SG
1978 年 2 月和 3 月在英国进行的一项双盲、多中心研究中，对 A/USSR/92/77 (H1N1) 流感病毒疫苗的全病毒、水性表面抗原 [Ag] 和吸附表面 Ag 的分级剂量的临床可接受性和抗体 [Ab] 反应进行了评估。疫苗病毒的神经氨酸酶抑制（NI）血清抗体很少出现，并且在年龄≤10岁的志愿者中滴度较低。 25 岁，但在老年人中更为常见。在 .ltoreq 岁的志愿者中。 25 岁的接种前 HI Ab 血清阴性的人，在接种 1 剂疫苗后，所有剂量和类型的疫苗的 HI Ab 反应频率和效价通常较低。具有高抗原含量的全病毒或亚单位疫苗（≥47μg血凝素（HA）/剂）在至少60%的接受者中诱导HI Ab反应。 2剂全病毒、每剂含有至少9μg HA的水性或吸附表面Ag疫苗后，血清HI滴度为.gtoreq。 69-100% 的接收者中检测到 40 种。在年龄为 .gtoreq 的志愿者中。 26 岁接受单剂含有至少 3 μg HA 的任何测试疫苗的人，HI Ab 反应频繁且疫苗后滴度为 .gtoreq。 80% 的疫苗接种者中检测到 40 种。对于每个年龄组，注意到整个病毒（5-94μg HA/剂量）或亚单位疫苗的大范围抗体浓度的“浅”剂量反应效应。几何平均 HI 抗体滴度和出现 HI 滴度的疫苗接种者比例 .gtoreq。当皮下注射同等剂量的疫苗时，每个年龄组的 40 例结果相似。和皮内途径。对疫苗接种的 NI Ab 反应的初步研究表明，所有全病毒和亚单位疫苗都刺激了部分接受者的血清 NI Ab。所有疫苗的临床耐受性均良好。
The clinical acceptability and antibody [Ab] responses to graded doses of whole virus, aqueous surface antigen [Ag] and adsorbed surface Ag of influenza A/USSR/92/77 (H1N1) virus vaccines were assessed in 1335 healthy [human] volunteers in a double-blind, multi-center study conducted in the UK in Feb. and March, 1978. Before vaccination the presence of hemagglutination-inhibiting (HI) and neuraminidase-inhibiting (NI) serum Ab to the vaccine virus was infrequent and in low titers in volunteers aged .ltoreq. 25 yr but was more frequent in older persons. In volunteers aged .ltoreq. 25 yr who were sero-negative for HI Ab before vaccination, the HI Ab responses following 1 dose of vaccine were generally of low frequency and titer for all doses and types of vaccine. Whole virus or subunit vaccines with high antigenic content (.gtoreq. 47 .mu.g hemagglutinin (HA)/dose) induced HI Ab responses in at least 60% of recipients. Following 2 doses of whole virus, aqueous or adsorbed surface Ag vaccine containing at least 9 .mu.g HA per dose, serum HI titers of .gtoreq. 40 were detected in 69-100% of recipients. In volunteers aged .gtoreq. 26 yr who received a single dose of any of the test vaccines containing at least 3 .mu.g HA, the HI Ab responses were frequent and post-vaccine titers of .gtoreq. 40 were detected in 80% of vaccinees. A ''shallow'' dose response effect over a wide range of Ab concentrations of whole virus (5-94 .mu.g HA/dose) or subunit vaccines was noted for each age group. The geometric mean HI Ab titers and proportion of vaccinees developing HI titers .gtoreq. 40 were similar for each age group when comparable doses of vaccine were given by the s.c. and intradermal routes. A preliminary study of the NI Ab responses to vaccination indicated that all the whole virus and subunit vaccines stimulated serum NI Ab in a proportion of recipients. All vaccines were clinically well tolerated.