一项比较细胞疫苗与减毒活疫苗在儿童中的免疫原性的随机对照试验。

A Randomized Controlled Trial to Compare Immunogenicity to Cell-Based Versus Live-Attenuated Influenza Vaccines in Children.

机构信息

Department of Family Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

National Center Immunizations and Respiratory Disease, Center for Disease Control and Prevention, Atlanta, Georgia, USA.

出版信息

J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):342-352. doi: 10.1093/jpids/piad033.

DOI:10.1093/jpids/piad033

PMID:37232430

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10312301/

Abstract

BACKGROUND

Few studies have focused on the immune response to more recent influenza vaccine formulations such as cell-cultured inactivated influenza vaccine (ccIIV4) or live-attenuated influenza vaccine (LAIV4) in older children and young adults, or differences in immunoglobulin response using newer antibody landscape technology.

METHODS

Participants ages 4-21 were randomized to receive ccIIV4 (n = 112) or LAIV4 (n = 118). A novel high-throughput multiplex influenza antibody detection assay was used to provide detailed IgG, IgA, and IgM antibody isotypes, along with hemagglutination inhibition levels (HAI), measured pre- and 28 days post-vaccination.

RESULTS

The HAI and immunoglobulin isotype response to ccIIV4 was greater than LAIV4, with significant increases in IgG but not IgA or IgM. The youngest participants had the highest LAIV4 response. Prior LAIV4 vaccination was associated with a higher response to current season ccIIV4. Cross-reactive A/Delaware/55/2019(H1N1)pdm09 antibodies were present pre-vaccination and increased in response to ccIIV4, but not LAIV4. Immunoglobulin assays strongly correlated with and confirmed the findings of HAI titers to measure immune response.

CONCLUSIONS

Age and prior season vaccination may play a role in the immune response in children and young adults to ccIIV4 and LAIV4. While immunoglobulin isotypes provide high-level antigen-specific information, HAI titers alone can provide a meaningful representation of day 28 post-vaccination response.

CLINICAL TRIALS NO

NCT03982069.

摘要

背景

很少有研究关注最近的流感疫苗制剂（如细胞培养的灭活流感疫苗[ccIIV4]或减毒活流感疫苗[LAIV4]）在较大儿童和年轻成人中的免疫反应，或使用新的抗体图谱技术在免疫球蛋白反应方面的差异。

方法

4-21 岁的参与者被随机分配接受 ccIIV4（n=112）或 LAIV4（n=118）。使用新型高通量多重流感抗体检测分析，提供详细的 IgG、IgA 和 IgM 抗体同种型，以及预接种和接种后 28 天的血凝抑制水平（HAI）。

结果

ccIIV4 的 HAI 和免疫球蛋白同种型反应大于 LAIV4，IgG 显著增加，但 IgA 或 IgM 没有增加。年龄最小的参与者对 LAIV4 的反应最高。先前接种过 LAIV4 与当前季节 ccIIV4 的更高反应相关。交叉反应性 A/Delaware/55/2019(H1N1)pdm09 抗体在接种前存在，并对 ccIIV4 有反应，但对 LAIV4 没有反应。免疫球蛋白检测与 HAI 滴度高度相关，并证实了测量免疫反应的结果。