A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR).

IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-03-18 DOI:10.1080/21645515.2024.2321035
Alvino Maestri, Su Eun Park, Fiona Fernandes, Zhongyi Lucy Li, Yae-Jean Kim, Yun-Kyung Kim, Jin Lee, Ji Young Park, Dong Hyun Kim, GyongSeon Yang, Hyunjung Lim, Jin Oh Kim, Robert Lupinacci, Tina M Sterling, Marissa Wilck, Alejandra Esteves-Jaramillo, Natalie Banniettis
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引用次数: 0

Abstract

There is an ongoing burden of pneumococcal disease in children despite the use of pneumococcal conjugate vaccines (PCVs). This phase 3, open-label, single-arm, multisite, descriptive study was designed to evaluate the safety and immunogenicity of a 3 + 1 regimen of V114 (VAXNEUVANCE™), a 15-valent PCV, in South Korean infants and toddlers. Adverse events (AEs) were reported for 14 d following any vaccination, and throughout the study period for serious AEs. Serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting an IgG threshold value of ≥0.35 μg/mL) and geometric mean concentrations (GMCs) for the 15 serotypes at 30 d postdose 3 (PD3) and at 30 d postdose 4 (PD4) were evaluated as endpoints. Healthy infants enrolled at 42-90 d after birth were vaccinated with V114 (N = 57). The most commonly reported AEs were those solicited in the trial. The majority of reported AEs were transient and of mild or moderate intensity. Few serious AEs were reported; none were vaccine related. No participants died nor discontinued the study vaccine because of an AE. V114 was immunogenic for all 15 serotypes contained in the vaccine, as assessed by IgG response rates at 30 d PD3 and IgG GMCs at 30 d PD3 and at 30 d PD4. V114 was well tolerated and immunogenic when administered as a 3 + 1 regimen in healthy South Korean infants and toddlers.

一项 3 期、单臂、开放标签研究,旨在评估 15 价肺炎球菌结合疫苗 V114 在韩国健康婴儿中采用 3+1 方案的安全性、耐受性和免疫原性 (PNEU-PED-KOR)。
尽管使用了肺炎球菌结合疫苗 (PCV),但儿童肺炎球菌疾病的负担仍在持续。这项 3 期、开放标签、单臂、多站点、描述性研究旨在评估 15 价 PCV V114 (VAXNEUVANCE™) 3 + 1 方案在韩国婴幼儿中的安全性和免疫原性。在接种任何疫苗后的 14 天内报告不良事件 (AE),在整个研究期间报告严重不良事件。血清型特异性免疫球蛋白 G (IgG) 反应率(达到 IgG 阈值≥0.35 μg/mL 的参与者比例)和 15 种血清型的几何平均浓度 (GMC) 作为终点进行评估,评估时间为接种后 30 天(PD3)和接种后 30 天(PD4)。出生后 42-90 天的健康婴儿接种了 V114 疫苗(57 人)。最常报告的AE是试验中征集的AE。大多数报告的不良反应是一过性的,属于轻度或中度。报告的严重不良反应很少;没有一起不良反应与疫苗有关。没有参与者死亡,也没有参与者因不良反应而停止接种疫苗。根据30 d PD3的IgG应答率以及30 d PD3和30 d PD4的IgG GMCs评估,V114对疫苗所含的全部15种血清型均具有免疫原性。在健康的韩国婴幼儿中以 3+1 方案接种 V114 疫苗,其耐受性和免疫原性良好。
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来源期刊
Human Vaccines & Immunotherapeutics
Human Vaccines & Immunotherapeutics BIOTECHNOLOGY & APPLIED MICROBIOLOGY-IMMUNOLOGY
CiteScore
7.90
自引率
8.30%
发文量
489
审稿时长
3-6 weeks
期刊介绍: (formerly Human Vaccines; issn 1554-8619) Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics. Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.
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