无论 HBGA 状态如何，印度尼西亚婴儿中 RV3-BB 轮状病毒疫苗的接种情况。

Vaccine Take of RV3-BB Rotavirus Vaccine Observed in Indonesian Infants Regardless of HBGA Status.

机构信息

Enteric Diseases Group, Murdoch Children's Research Institute.

Department of Paediatrics, The University of Melbourne, Parkville.

出版信息

J Infect Dis. 2024 Apr 12;229(4):1010-1018. doi: 10.1093/infdis/jiad351.

DOI:10.1093/infdis/jiad351

PMID:37592804

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11011179/

Abstract

BACKGROUND

Histo-blood group antigen (HBGA) status may affect vaccine efficacy due to rotavirus strains binding to HBGAs in a P genotype-dependent manner. This study aimed to determine if HBGA status affected vaccine take of the G3P[6] neonatal vaccine RV3-BB.

METHODS

DNA was extracted from stool samples collected in a subset (n = 164) of the RV3-BB phase IIb trial in Indonesian infants. FUT2 and FUT3 genes were amplified and sequenced, with any single-nucleotide polymorphisms analyzed to infer Lewis and secretor status. Measures of positive cumulative vaccine take were defined as serum immune response (immunoglobulin A or serum-neutralizing antibody) and/or stool excretion of RV3-BB virus. Participants were stratified by HBGA status and measures of vaccine take.

RESULTS

In 147 of 164 participants, Lewis and secretor phenotype were determined. Positive vaccine take was recorded for 144 (97.9%) of 147 participants with the combined phenotype determined. Cumulative vaccine take was not significantly associated with secretor status (relative risk, 1.00 [95% CI, .94-1.06]; P = .97) or Lewis phenotype (relative risk, 1.03 [95% CI, .94-1.14]; P = .33), nor was a difference observed when analyzed by each component of vaccine take.

CONCLUSIONS

The RV3-BB vaccine produced positive cumulative vaccine take, irrespective of HBGA status in Indonesian infants.

摘要

背景

由于轮状病毒株以 P 基因型依赖的方式与 HBGA 结合，因此组织血型抗原（HBGA）状态可能会影响疫苗的效果。本研究旨在确定 HBGA 状态是否会影响 G3P[6]新生儿疫苗 RV3-BB 的疫苗接种效果。

方法

从印度尼西亚婴儿的 RV3-BB 二期临床试验的子集中（n = 164）提取粪便样本中的 DNA。扩增和测序 FUT2 和 FUT3 基因，分析任何单核苷酸多态性以推断 Lewis 和分泌状态。阳性累计疫苗接种效果的衡量标准是血清免疫应答（免疫球蛋白 A 或血清中和抗体）和/或 RV3-BB 病毒在粪便中的排泄。根据 HBGA 状态和疫苗接种效果衡量标准对参与者进行分层。

结果

在 164 名参与者中的 147 名中，确定了 Lewis 和分泌表型。根据确定的组合表型，147 名参与者中有 144 名（97.9%）记录了阳性疫苗接种效果。累积疫苗接种效果与分泌状态（相对风险，1.00[95%CI，.94-1.06]；P =.97）或 Lewis 表型（相对风险，1.03[95%CI，.94-1.14]；P =.33）无显著相关性，也未观察到在按每种疫苗接种效果成分分析时存在差异。