Studies on reactogenicity and immunogenicity of attenuated bivalent cold recombinant influenza type A (CRA) and inactivated trivalent influenza virus (TI) vaccines in infants and young children.
Studies on reactogenicity and immunogenicity of attenuated bivalent cold recombinant influenza type A (CRA) and inactivated trivalent influenza virus (TI) vaccines in infants and young children.
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婴幼儿减毒二价冷重组甲型流感疫苗（CRA）和灭活三价流感病毒（TI）疫苗的反应原性和免疫原性研究。
DOI：
10.1016/0264-410x(93)90255-v
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发表时间：
1993
期刊：
影响因子：
5.5
通讯作者：
Rhodes,LJ
中科院分区：
文献类型：
--
作者：
Piedra,PA;Glezen,WP;Mbawuike,I;Gruber,WC;Baxter,BD;Boland,FJ;Byrd,RW;Fan,LL;Lewis,JK;Rhodes,LJ
52名对A型流感病毒血清阴性或既往未感染的婴儿入组研究，以评价三种二价重组A型冷（CRA）和两种三价灭活流感（TI）疫苗的反应原性和免疫原性。对照组包括通过滴鼻剂接受生理盐水的婴儿（Pli. n.）或肌内注射（Pli.m.）。CRA和TI疫苗接种者在接种后监测局部和全身反应。对接种前和接种后6周获得的血清标本进行H1N1和H3 N2流感病毒中和抗体分析。在试验期间，CRA疫苗接种者和Pli.n.接受者的急性呼吸道感染数量相似，患病率也相似。没有并发病毒感染的CRA疫苗接种者出现发热（0/16对4/10，p= 0.04）和咳嗽（4/16对9/10，p= 0.002）的人数显著少于确诊并发病毒感染的CRA疫苗接种者。接种TI疫苗和Pli.m.的受者在注射部位未发生反应。对于测试的每种CRA疫苗，鉴定了优势CRA病毒。与非优势CRA病毒相比，优势CRA病毒从更多婴儿中分离或分离持续时间更长。所有14种非显性CRA病毒均在接种后第一周内从婴儿体内回收; 77种显性CRA病毒中有24种在接种后7天以上回收。CRA疫苗的免疫原性不受确认的并发病毒感染或低滴度流感特异性抗体的影响。然而，在二价CRA疫苗中的CRA病毒之间观察到干扰。TI疫苗的免疫原性可能受到低滴度流感特异性抗体的影响。
Fifty-two infants seronegative to or without prior infection with influenza type A viruses were enrolled in a study to evaluate reactogenicity and immunogenicity of three bivalent cold recombinant type A (CRA) and two trivalent inactivated influenza (TI) vaccines. Controls consisted of infants receiving normal saline by nose drops (Pli.n.) or intramuscularly (Pli.m.). CRA and TI vaccinees were monitored for local and systemic reactions after vaccination. Serum specimens obtained prior to and 6 weeks postvaccination were analysed for neutralizing antibody to influenza H1N1 and H3N2 viruses. CRA vaccinees and Pli.n.recipients had similar numbers of acute respiratory infections and comparable rates of illnesses during the trial. Significantly fewer CRA vaccinees without an intercurrent viral infection had fever (0/16 versus 4/10,p= 0.04) and cough (4/16 versus 9/10,p= 0.002) than CRA vaccinees with a confirmed intercurrent viral infection. Recipients of TI vaccine and Pli.m.did not develop reactions at the injection site. For each of the CRA vaccines tested, a dominant CRA virus was identified. The dominant CRA viruses were isolated from a greater number of infants or for a longer duration than the non-dominant CRA viruses. All 14 non-dominant CRA viruses were recovered from infants within the first week after vaccination; 24 of 77 dominant CRA viruses were recovered more than 7 days after vaccination. The immunogenicity of CRA vaccines was not affected by a confirmed intercurrent viral infection or low titres of influenza-specific antibody. However, interference was observed between the CRA viruses in the bivalent CRA vaccines. Immunogenicity of TI vaccine may have been affected by low titres of influenza-specific antibody.