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在先前接种一剂 Tdap(吸附破伤风类毒素、白喉类毒素和无细胞百日咳疫苗)后 4-5 年,对青少年和成年人进行破伤风类毒素、减量白喉类毒素和无细胞百日咳疫苗吸附(Tdap)加强免疫的耐受性和抗体应答。

Tolerability and antibody response in adolescents and adults revaccinated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) 4-5 years after a previous dose.

机构信息

Canadian Center for Vaccinology, Dalhousie University, Halifax, NS, Canada.

出版信息

Vaccine. 2011 Oct 26;29(46):8459-65. doi: 10.1016/j.vaccine.2011.07.068. Epub 2011 Jul 29.

Abstract

BACKGROUND

Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine is not currently recommended for adults.

METHODS

This open-label, postmarketing, multicenter study evaluated the tolerability and immunogenicity of a second dose of an adult formulation of tetanus, diphtheria, and pertussis vaccine (Tdap) in adolescents and adults 5 years after a first dose.

RESULTS

A total of 545 participants from previous Tdap vaccine studies, ranging in age from 15 to 69 years, participated in this study. Of these participants, 94.2% had at least one solicited adverse event after the booster dose such as injection-site erythema (28.6%), swelling (25.6%), or pain (87.6%) or a systemic adverse event such as myalgia (61.0%), headache (53.2%), malaise (38.2%), or fever (6.5%). These adverse events were slightly more frequent than after the initial dose. Postvaccination, 100% of participants had a tetanus antibody level ≥0.10IU/mL and 95% had a diphtheria antibody level ≥0.10IU/mL. For pertussis, 82.1% (pertussis toxoid), 96.7% (filamentous hemagglutinin), 95.6% (pertactin), and 99.8% (fimbriae) had a postvaccination antibody threshold of ≥50EU/mL.

CONCLUSION

A second dose of Tdap vaccine 5 years after the initial dose was well tolerated and immunogenic in adolescents and adults.

摘要

背景

尽管加拿大和美国建议每十年为成年人加强破伤风类毒素和白喉类毒素,但目前不建议成年人再次接种百日咳疫苗。

方法

这项开放性、上市后、多中心研究评估了青少年和成年人在首次接种破伤风、白喉和无细胞百日咳疫苗(Tdap)后 5 年内再次接种成人配方 Tdap 的耐受性和免疫原性。

结果

共有 545 名来自之前 Tdap 疫苗研究的参与者参加了这项研究,年龄在 15 至 69 岁之间。这些参与者中,94.2%在加强剂量后至少有一次不良事件,如注射部位红斑(28.6%)、肿胀(25.6%)或疼痛(87.6%)或全身不良事件,如肌痛(61.0%)、头痛(53.2%)、不适(38.2%)或发热(6.5%)。这些不良事件比初次接种后略为频繁。接种后,100%的参与者破伤风抗体水平≥0.10IU/mL,95%的参与者白喉抗体水平≥0.10IU/mL。对于百日咳,82.1%(百日咳类毒素)、96.7%(丝状血凝素)、95.6%(百日咳黏附素)和 99.8%(菌毛)的抗体阈值≥50EU/mL。

结论

在初次接种后 5 年内再次接种 Tdap 疫苗,在青少年和成年人中具有良好的耐受性和免疫原性。

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