Combination vaccines consisting of acellular pertussis vaccines.
Combination vaccines consisting of acellular pertussis vaccines.
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由无细胞百日咳疫苗组成的联合疫苗。
DOI：
10.1097/00006454-199704001-00005
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发表时间：
1997
期刊：
影响因子：
--
通讯作者：
Decker,MD
中科院分区：
文献类型：
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作者：
Edwards,KM;Decker,MD
由多个疫苗抗原组成的组合疫苗在一次注射中可以简化疫苗管理。然而，将多种抗原组合成一针疫苗的前提是，联合使用多种疫苗不会降低成分疫苗的安全性和免疫原性。新一代疫苗寻求将来自多个不同病原体的更多抗原结合在一起，这使得它们很难在受控、双盲、随机的临床试验中进行研究，因为完成评估需要大量的研究臂。简化联合疫苗研究的方法包括建立在早期研究的框架上，以计算样本量和减少对照臂数，标准化血清学分析和不良反应评估，确定保护的血清学相关性，以最大限度地减少对多重疗效研究的需要，并促进免疫原性研究的评估。初步数据表明，包括白喉-破伤风百日咳、乙肝和灭活脊髓灰质炎病毒在内的联合疫苗的免疫应答与单独接种疫苗时的免疫应答相当。相比之下，包括b型流感嗜血杆菌Hib抗原的联合疫苗研究显示，Hib抗体反应减弱，尽管这种降低的抗体反应的临床相关性尚未确定。许多联合疫苗的小型安全性研究没有发现不良反应增加的证据。
Combination vaccines consisting of multiple vaccine antigens delivered in a single injection simplify vaccine administration. Combining multiple antigens into one injection, however, presupposes that the administration of multiple vaccines in combination will not reduce the safety and immunogenicity of the component vaccines. New generation vaccines seek to combine many more antigens from multiple, different pathogens, making them difficult to study in controlled, double blind, randomized clinical trials because of the number of study arms required for complete evaluation. Methods to simplify studies of combination vaccines include building on the framework of earlier studies to calculate sample size and reduce the number of control arms, standardizing serologic assays and assessment of adverse reactions and determining serologic correlates of protection to minimize the need for multiple efficacy studies and to facilitate evaluation of immunogenicity studies. Preliminary data indicate that immune responses to combination vaccines including diphtheria-tetanusacellular pertussis, hepatitis B and inactivated poliovirus are comparable with those seen when the vaccines are administered separately. In contrast studies of combination vaccines that include Haemophilus influenzae type b Hib antigens show a diminished Hib antibody response, although the clinical relevance of this lowered antibody response has not yet been determined. Numerous small safety studies of combined vaccines have not found evidence of increased adverse reactions.