A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization.
A randomized clinical trial of acellular pertussis vaccines in healthy adults: dose-response comparisons of 5 vaccines and implications for booster immunization.
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健康成人无细胞百日咳疫苗的随机临床试验：5 种疫苗的剂量反应比较及其对加强免疫的影响。
DOI：
10.1086/314869
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发表时间：
1999
期刊：
影响因子：
--
通讯作者：
Edwards,KM
中科院分区：
文献类型：
--
作者：
Keitel,WA;Muenz,LR;Decker,MD;Englund,JA;Mink,CM;Blumberg,DA;Edwards,KM
采用多中心、随机、双盲试验方法，比较了5种无细胞百日咳疫苗（ACV）的安全性和免疫原性。共有481名健康成年人接受了单次肌肉注射ACV或安慰剂的加强剂量。对4种阿昔洛韦进行了三种不同剂量水平的试验：全强度（婴儿免疫的建议剂量水平）、三分之一强度和十分之一强度。对于1种多组分疫苗，仅百日咳类毒素剂量水平发生变化。轻微的注射部位反应很常见，并且在接种组中的频率相似。在所有ACV组中均观察到迟发性注射部位反应。所有无环鸟苷免疫后，均观察到抗疫苗抗原的平均抗体滴度呈剂量相关性增加。用4/5的ACV免疫后，检测到针对疫苗中未知抗原的抗体应答。免疫后一年内抗体水平显著下降。这些数据支持对ACV进行评价，以便在青少年和成人中更广泛地使用。
The safety and immunogenicity of 5 acellular pertussis vaccines (ACVs) were compared in a multicenter, randomized, double-blind trial. A total of 481 healthy adults were given a single intramuscular booster dose of ACV or placebo. Three different dose levels were tested for 4 ACVs: full strength (the dose level proposed for infant immunization), one-third strength, and one-tenth strength. For 1 multicomponent vaccine, only the pertussis toxoid dose level varied. Minor injection site reactions were common and similar in frequency among vaccinated groups. Late-onset injection site reactions were seen in all ACV groups. Dose-related increases in mean antibody titers against vaccine antigens were seen after immunization with all ACVs. Antibody responses against antigens not known to be present in the vaccines were detected after immunization with 4/5 ACVs. Antibody levels fell significantly during the year after immunization. These data support evaluation of ACVs for broader use among adolescents and adults.