Combined immunogenicity evaluation for a new single-dose live-attenuated chikungunya vaccine.

IF 9.1 2区医学 Q1 INFECTIOUS DISEASES

Journal of travel medicine Pub Date : 2024-10-19 DOI:10.1093/jtm/taae084

Vera Buerger, Gabriele Maurer, Karin Kosulin, Romana Hochreiter, Julian Larcher-Senn, Katrin Dubischar, Susanne Eder-Lingelbach

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引用次数: 0

Abstract

Background: Chikungunya is a serious and debilitating viral infection with a significant disease burden. VLA1553 (IXCHIQ®) is a live-attenuated vaccine licensed for active immunization for prevention of disease caused by chikungunya virus (CHIKV).

Methods: Immunogenicity following a single dose of VLA1553 was evaluated in healthy adults aged ≥18 years in two Phase 3 trials [N = 656 participants (per protocol analysis set)]. Immunogenicity data to 180 days post-vaccination [geometric mean titres (GMTs), seroresponse rate, seroconversion rate] were pooled for the two trials. A comparison of subgroups based on age, sex, body mass index (BMI), race and baseline seropositivity was included. All analyses were descriptive.

Results: Most participants were aged 18-64 years (N = 569/656 [86.7%]), there were slightly more females (N = 372/656 [56.7%]), most were not Hispanic/Latino (N = 579/656 [88.3%]), and most were White (N = 517/656 [78.8%]). In baseline seronegative participants, GMT peaked at Day 29 post-vaccination, and subsequently declined slightly but remained elevated until Day 180. At Days 29, 85 and 180, seroresponse rate was 98.3, 97.7 and 96.4% and seroconversion rate was 98.5, 98.4 and 98.2%. There were no differences in seroresponse rate in participants aged 18-64 years or ≥65 years at Day 29 (98.1 vs 100%), Day 85 (97.4 vs 100%) and Day 180 (96.3 vs 96.5%) nor based on sex, BMI, ethnicity or race. An immune response was shown in a small heterogenous population of baseline seropositive participants, with GMTs showing the same trend as baseline seronegative participants.

Conclusions: A single dose of VLA1553 elicited a very strong immune response by Day 29 that remained elevated at Day 180 in both baseline seronegative and seropositive participants in a combined evaluation of two Phase 3 trials. The vaccine was similarly immunogenic in participants aged ≥65 years and 18-64 years, and there were no differences based on subgroup analyses for sex, BMI, ethnicity or race.

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新型单剂量减毒基孔肯雅病活疫苗的联合免疫原性评估。

背景：基孔肯雅病毒是一种严重的致残性病毒感染，对疾病造成了巨大的负担。VLA1553（IXCHIQ®）是一种减毒活疫苗，获准用于主动免疫，预防由基孔肯雅病毒（CHIKV）引起的疾病：在两项3期试验中，对年龄≥18岁的健康成人接种单剂VLA1553后的免疫原性进行了评估（N = 656人[每套方案分析组]）。两项试验汇总了接种后 180 天的免疫原性数据（几何平均滴度 [GMT]、血清反应率、血清转换率）。根据年龄、性别、体重指数（BMI）、种族和基线血清阳性率对亚组进行了比较。所有分析均为描述性分析：大多数参与者年龄在 18-64 岁之间（N = 569/656 [86.7%]），女性略多（N = 372/656 [56.7%]），大多数不是西班牙裔/拉丁美洲裔（N = 579/656 [88.3%]），大多数是白人（N = 517/656 [78.8%]）。在血清基线阴性的参与者中，GMT 在接种后第 29 天达到峰值，随后略有下降，但在第 180 天之前一直保持升高。在第 29、85 和 180 天，血清反应率分别为 98.3%、97.7% 和 96.4%，血清转换率分别为 98.5%、98.4% 和 98.2%。在第 29 天（98.1% 对 100%）、第 85 天（97.4% 对 100%）和第 180 天（96.3% 对 96.5%），18-64 岁或≥65 岁的参与者的血清反应率没有差异，性别、体重指数、民族或种族也没有差异。在一小部分血清基线呈阳性的异质人群中出现了免疫反应，GMT与血清基线呈阴性的人群趋势相同：结论：在两项3期试验的综合评估中，单剂VLA1553在第29天引起了非常强烈的免疫应答，在第180天时，基线血清阴性和血清阳性参与者的免疫应答仍然升高。在年龄≥65岁和18-64岁的参与者中，疫苗的免疫原性相似，根据性别、体重指数、民族或种族进行的亚组分析也没有发现差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of travel medicine 医学-医学：内科

CiteScore

20.90

自引率

5.10%

发文量

143

审稿时长

6-12 weeks

期刊介绍： The Journal of Travel Medicine is a publication that focuses on travel medicine and its intersection with other disciplines. It publishes cutting-edge research, consensus papers, policy papers, and expert reviews. The journal is affiliated with the Asia Pacific Travel Health Society. The journal's main areas of interest include the prevention and management of travel-associated infections, non-communicable diseases, vaccines, malaria prevention and treatment, multi-drug resistant pathogens, and surveillance on all individuals crossing international borders. The Journal of Travel Medicine is indexed in multiple major indexing services, including Adis International Ltd., CABI, EBSCOhost, Elsevier BV, Gale, Journal Watch Infectious Diseases (Online), MetaPress, National Library of Medicine, OCLC, Ovid, ProQuest, Thomson Reuters, and the U.S. National Library of Medicine.