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用于青少年的无细胞百白破联合疫苗加强针

Acellular pertussis vaccine booster combined with diphtheria and tetanus toxoids for adolescents.

作者信息

Pichichero Michael E, Blatter Mark M, Kennedy William A, Hedrick James, Descamps Dominique, Friedland Leonard R

机构信息

University of Rochester Medical Center, Rochester, NY 14642, USA.

出版信息

Pediatrics. 2006 Apr;117(4):1084-93. doi: 10.1542/peds.2005-1759.

Abstract

BACKGROUND

The incidence of pertussis is increasing, especially in adolescents, attributed in part to waning of immunity after childhood immunization. Recently licensed in the United States for use in adolescents, acellular pertussis vaccines will provide an immunogenic and safe option for booster immunization against pertussis.

METHODS

This prospective, randomized, observer-blinded, multicenter, comparative study evaluated the safety and immunogenicity of a vaccine formulated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis antigens (Tdap) compared with tetanus and diphtheria toxoids vaccine (Td) for booster immunization in adolescents. There were 4114 healthy adolescents aged 10 to 18 years who completed childhood vaccination against diphtheria, tetanus, and pertussis who were enrolled, randomized, and received study vaccine.

RESULTS

Local and general symptoms were comparable between the Tdap and Td groups. The immune response of Tdap was comparable with Td vaccine for tetanus and diphtheria seroprotection and booster responses. In addition, geometric mean concentrations of antibody to pertussis antigens, pertussis toxoid, filamentous hemagglutinin, and pertactin exceeded the antibody response elicited after infant immunization with diphtheria and tetanus toxoids and acellular pertussis antigens (DTaP) that had proven efficacy against pertussis.

CONCLUSIONS

In adolescents, the studied Tdap was safe and immunogenic and induced pertussis antibodies that were higher than those associated with efficacy in infants.

摘要

背景

百日咳的发病率正在上升,尤其是在青少年中,部分原因是儿童期免疫后免疫力下降。无细胞百日咳疫苗最近在美国被批准用于青少年,将为百日咳加强免疫提供一种具有免疫原性且安全的选择。

方法

这项前瞻性、随机、观察者盲法、多中心比较研究评估了一种由破伤风类毒素、减毒白喉类毒素和无细胞百日咳抗原(Tdap)配制的疫苗与破伤风和白喉类毒素疫苗(Td)在青少年加强免疫中的安全性和免疫原性。共有4114名年龄在10至18岁、完成白喉、破伤风和百日咳儿童期疫苗接种的健康青少年被纳入研究,随机分组并接受研究疫苗。

结果

Tdap组和Td组的局部和全身症状相当。Tdap在破伤风和白喉血清保护及加强反应方面的免疫反应与Td疫苗相当。此外,针对百日咳抗原、百日咳类毒素、丝状血凝素和百日咳杆菌黏附素的抗体几何平均浓度超过了婴儿接种白喉和破伤风类毒素及无细胞百日咳抗原(DTaP)后引发的抗体反应,而DTaP已被证明对百日咳有效。

结论

在青少年中,所研究的Tdap安全且具有免疫原性,并诱导产生了高于婴儿期与有效性相关水平的百日咳抗体。

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