单价轮状病毒疫苗对不同轮状病毒基因型的疗效：Ⅱ期和Ⅲ期临床试验数据的汇总分析。
Monovalent Rotavirus Vaccine Efficacy Against Different Rotavirus Genotypes: A Pooled Analysis of Phase II and III Trial Data.
机构信息
Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
出版信息
Clin Infect Dis. 2023 Feb 8;76(3):e1150-e1156. doi: 10.1093/cid/ciac699.
BACKGROUND
Rotavirus vaccine performance appears worse in countries with high rotavirus genotype diversity. Evidence suggests diminished vaccine efficacy (VE) against G2P[4], which is heterotypic with existing monovalent rotavirus vaccine formulations. Most studies assessing genotype-specific VE have been underpowered and inconclusive.
METHODS
We pooled individual-level data from 10 Phase II and III clinical trials of rotavirus vaccine containing G1 and P[8] antigens (RV1) conducted between 2000 and 2012. We estimated VE against both any-severity and severe (Vesikari score ≥11) rotavirus gastroenteritis (RVGE) using binomial and multinomial logistic regression models for non-specific VE against any RVGE, genotype-specific VE, and RV1-typic VE against genotypes homotypic, partially heterotypic, or fully heterotypic with RV1 antigens. We adjusted models for concomitant oral poliovirus and RV1 vaccination and the country's designated child mortality stratum.
RESULTS
Analysis included 87 644 infants from 22 countries in the Americas, Europe, Africa, and Asia. For VE against severe RVGE, non-specific VE was 91% (95% confidence interval [CI]: 87-94%). Genotype-specific VE ranged from 96% (95% CI: 89-98%) against G1P[8] to 71% (43-85%) against G2P[4]. RV1-typic VE was 92% (95% CI: 84-96%) against partially heterotypic genotypes but 83% (67-91%) against fully heterotypic genotypes. For VE against any-severity RVGE, non-specific VE was 82% (95% CI: 75-87%). Genotype-specific VE ranged from 94% (95% CI: 86-97%) against G1P[8] to 63% (41-77%) against G2P[4]. RV1-typic VE was 83% (95% CI: 72-90%) against partially heterotypic genotypes but 63% (40-77%) against fully heterotypic genotypes.
CONCLUSIONS
RV1 VE is comparatively diminished against fully heterotypic genotypes including G2P[4].
背景
轮状病毒疫苗在基因型多样性较高的国家的表现似乎较差。有证据表明，该疫苗对 G2P[4]的效力降低，而 G2P[4]与现有的单价轮状病毒疫苗配方不同型。大多数评估基因型特异性疫苗效力的研究都没有足够的效力和结论。
方法
我们汇集了 2000 年至 2012 年期间进行的含有 G1 和 P[8]抗原的轮状病毒疫苗（RV1）的 10 项 II 期和 III 期临床试验的个体水平数据。我们使用二项式和多项逻辑回归模型估计了针对任何严重程度和严重程度（Vesikari 评分≥11）轮状病毒胃肠炎（RVGE）的疫苗效力，针对任何 RVGE 的非特异性疫苗效力、基因型特异性疫苗效力以及针对与 RV1 抗原同型、部分异型或完全异型的基因型的 RV1 型疫苗效力。我们针对同时口服脊髓灰质炎病毒和 RV1 疫苗接种以及国家指定的儿童死亡率分层调整了模型。
结果
分析包括来自美洲、欧洲、非洲和亚洲 22 个国家的 87644 名婴儿。对于严重 RVGE 的疫苗效力，非特异性疫苗效力为 91%（95%置信区间[CI]：87-94%）。基因型特异性疫苗效力从 G1P[8]的 96%（95%CI：89-98%）到 G2P[4]的 71%（43-85%）不等。针对部分异型基因型的 RV1 型疫苗效力为 92%（95%CI：84-96%），但针对完全异型基因型的疫苗效力为 83%（67-91%）。对于任何严重程度的 RVGE 的疫苗效力，非特异性疫苗效力为 82%（95%CI：75-87%）。基因型特异性疫苗效力从 G1P[8]的 94%（95%CI：86-97%）到 G2P[4]的 63%（41-77%）不等。针对部分异型基因型的 RV1 型疫苗效力为 83%（95%CI：72-90%），但针对完全异型基因型的疫苗效力为 63%（40-77%）。
结论
RV1 疫苗效力相对于包括 G2P[4]在内的完全异型基因型降低。
Zotero 插件