Yale School of Medicine, Section of Infectious Diseases, New Haven, CT, USA.
Yale School of Public Health, New Haven, CT, USA.
Vaccine. 2024 Nov 14;42(25):126053. doi: 10.1016/j.vaccine.2024.06.021. Epub 2024 Jun 21.
Before the global mpox outbreak which began in 2022, the real-world vaccine effectiveness (VE) of mpox vaccines was unknown. We quantified the VE in the global population of 3rd generation or later mpox vaccines (MVA-BN, LC16m8, OrthopoxVac) compared with unvaccinated or other vaccinated states for infection, hospitalization and death. VE was stratified by 1-dose and 2-doses and post-exposure prophylaxis (PEP).
Studies were included if they measured vaccine efficacy or effectiveness in humans. Animal studies and immunogenicity studies were excluded. MEDLINE, Web of Science, Google Scholar, Embase, MedRxiv and grey literature were searched from January 1st, 1970, with the last search run on November 3, 2023 (Prospero, CRD42022345240). Risk of publication bias was assessed via funnel plots and Egger's test, and study quality via Newcastle-Ottawa scales.
A total of 11,892 records were identified via primary search, 3,223 via citation chasing. Thirty-three studies were identified of 3rd generation vaccines, 32 of which were MVA-BN. Two additional studies were re-analysis of existing data. Most of these studies were focused on gay, bisexual, or other men who have sex with men between the ages of 18-49 in May to October of 2022. VE of 1 dose of MVA-BN was 76% (95%CI 64-88%) from twelve studies. VE of 2 doses was 82% (95%CI 72-92%) from six studies. VE of MVA-BN PEP against mpox was 20% (95%CI -24-65%) from seven studies. All VE are calculated from random effects estimates. 18/33(55%) studies were rated as poor, 3/33(9%) as fair and 12/33(36%) as good. Studies included in the meta-analysis had higher quality: 11/16 (69%) were rated as good quality.
Both 1 and 2 doses of MVA-BN are highly effective at preventing mpox. Effectiveness estimates, specifically of PEP are limited by immortal time bias, predominant mode of mpox transmission, and real-world vaccine timing of administration.
在 2022 年开始的全球猴痘疫情爆发之前，第三代猴痘疫苗（MVA-BN、LC16m8、OrthoPoxVac）的真实世界疫苗有效性（VE）尚不清楚。我们比较了全球范围内接种第三代疫苗和未接种或接种其他疫苗人群的感染、住院和死亡的 VE。VE 按一剂和两剂以及暴露后预防（PEP）进行分层。
如果研究测量了疫苗在人类中的功效或效力，则将其纳入研究。排除动物研究和免疫原性研究。从 1970 年 1 月 1 日开始，在 MEDLINE、Web of Science、Google Scholar、Embase、MedRxiv 和灰色文献中进行了搜索，并于 2023 年 11 月 3 日进行了最后一次搜索（Prospero、CRD42022345240）。通过漏斗图和 Egger 检验评估发表偏倚风险，并通过 Newcastle-Ottawa 量表评估研究质量。
通过初步搜索共确定了 11892 条记录，通过引文追踪确定了 3223 条记录。确定了 33 项关于第三代疫苗的研究，其中 32 项为 MVA-BN。另外两项研究是对现有数据的重新分析。这些研究大多集中在 2022 年 5 月至 10 月期间年龄在 18-49 岁的男同性恋、双性恋或其他与男性发生性关系的男性。12 项研究表明，一剂 MVA-BN 的 VE 为 76%（95%CI 64-88%）。6 项研究表明，两剂 MVA-BN 的 VE 为 82%（95%CI 72-92%）。7 项研究表明，MVA-BN PEP 对猴痘的 VE 为 20%（95%CI -24-65%）。所有 VE 均来自随机效应估计。33 项研究中有 18 项（55%）被评为较差，3 项（9%）评为一般，12 项（36%）评为较好。纳入荟萃分析的研究质量较高：16 项研究中有 11 项（69%）评为质量较好。
一剂和两剂 MVA-BN 均能高度有效预防猴痘。PEP 的有效性估计值特别受到免疫时间偏倚、猴痘主要传播模式和现实世界疫苗接种时间的限制。
