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接种黄热病疫苗后 8 年志愿者的免疫持久性:一项剂量反应研究。

Duration of post-vaccination immunity to yellow fever in volunteers eight years after a dose-response study.

机构信息

Bio-Manguinhos/Fiocruz, Brazil.

Bio-Manguinhos/Fiocruz, Brazil.

出版信息

Vaccine. 2018 Jun 27;36(28):4112-4117. doi: 10.1016/j.vaccine.2018.05.041. Epub 2018 May 18.

Abstract

UNLABELLED

In 2009, Bio-Manguinhos conducted a dose-response study with the yellow fever vaccine, administering the vaccine in the usual mean dose of 27,476 IU (full dose, reference) and in tapered doses (10,447 IU, 3013 IU, 587 IU, 158 IU, and 31 IU) by the usual subcutaneous route and usual volume (0.5 mL). Tapered doses were obtained by dilution in the manufacturer's laboratory, and the test batches presented industrial quality. Doses down to 587 IU showed similar immunogenicity to the full dose (27,476, reference), while the 158 IU and 31 IU doses displayed lower immunogenicity. Seropositivity was maintained at 10 months, except in the group that received the 31 IU dose. The current study aims to determine whether yellow fever seropositivity was maintained eight years after YF vaccination in non-revaccinated individuals. According to the current study's results, seropositivity was maintained in 85% of 318 participants and was similar across groups. The findings support the use of the yellow fever vaccine in fractional doses during outbreaks, but each fractional dose should have at least 587 IU. This study also supports the minimum dose required by WHO, 1000 IU.

CLINICAL TRIALS REGISTRATION

Clinicaltrials.gov NCT 03338231.

摘要

目的

本研究旨在确定在非再次接种人群中,接种 YF 疫苗 8 年后黄热病血清阳性是否得以维持。

方法

2009 年,Bio-Manguinhos 开展了一项与黄热病疫苗相关的剂量反应研究,以常规皮下途径和常规剂量(0.5 mL)给予常规剂量(27476 IU,参照组)和递减剂量(10447 IU、3013 IU、587 IU、158 IU 和 31 IU)。递减剂量由生产商实验室稀释获得,且测试批次具有工业质量。结果:剂量降至 587 IU 时与全剂量(27476 IU,参照组)具有相似的免疫原性,而 158 IU 和 31 IU 剂量的免疫原性较低。除接受 31 IU 剂量的组外,血清阳性率可维持至 10 个月。本研究共纳入 318 名参与者,结果显示,85%的非再次接种人群黄热病血清阳性得以维持,且各分组间无显著差异。该研究结果支持在暴发期间使用减毒黄热病疫苗,但每个减毒剂量应至少为 587 IU。此外,本研究还支持 WHO 提出的最低剂量要求,即 1000 IU。

结论

该研究结果表明,在非再次接种人群中,接种 YF 疫苗 8 年后黄热病血清阳性得以维持,且各分组间无显著差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce56/6026294/24bebc6e5223/gr1.jpg

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