2025年3月27日，加拿大北部巴伐利亚Patrick Ajiboye团队在《柳叶刀》杂志发表论文，他们报道了基孔肯雅病毒样颗粒疫苗在65岁以上成年人中的安全性和免疫原性。

背景:65岁以上的成年人患基孔肯雅病非典型表现以及包括死亡在内的严重后果的风险增加。

方法:在这项随机、双盲、安慰剂对照、平行组的3期试验中，65岁及以上的成年人在美国的10个地点接受了单次肌肉注射Vimkunya（以前是基孔肯雅病毒样颗粒疫苗）或安慰剂。受试者、临床现场人员和申办者被分配到单独的治疗方案，直到所有的受试者完成他们的试验，数据库被清理和锁定。在选定的时间点评估基线和接种基孔肯雅病毒后血清中和抗体（NT80）滴度。在给药后183天，对所有提供安全性评估数据的暴露人群参与者进行了安全性评估。

发现:在2022年5月12日至12月2日期间，招募了413名参与者并随机分配（1:1）接受Vimkunya疫苗（n=206）或安慰剂（n=207）。与安慰剂和几何平均滴度相比，基孔肯雅病毒SNA滴度在第22天达到了免疫优势的主要终点。Vimkunya在第15天诱导了181名参与者中的149名（82%）(95% CI为76,1 - 82,22天，189名参与者中有165名（87%）（88,8 - 93.1），184名参与者中有139名（76%）（68,9 - 82,183天）的保护性血清反应（SNA NT80≥100，被认为是推定的血清保护性抗体反应）。虽然65-74岁年龄组在第15天的早期免疫应答略高于75岁及以上年龄组，但第22天和第183天的血清应答率相似。两组间不良事件发生率无显著差异，大多数不良事件严重程度为1级或2级，持续时间短。未发生与疫苗相关的严重不良事件或死亡。

研究结果表明，课题组研究人员提供了来自65岁及以上成年人的可靠数据，显示Vimkunya耐受性良好，并且在接种后2周和6个月的随访期间可以提供很高的保护率。

附：英文原文

Title: Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial

Author: Lauren C Tindale, Jason S Richardson, Deborah M Anderson, Jason Mendy, Sufia Muhammad, Tobi Loreth, Sarah Royalty Tredo, Roshan Ramanathan, Victoria A Jenkins, Lisa Bedell, Patrick Ajiboye

Issue&Volume: 2025-03-27

Abstract: Background

Adults older than 65 years are at increased risk for atypical presentations of chikungunya disease, as well as for severe outcomes including death.

Methods

In this phase 3, randomised, double-blind, placebo-controlled, parallel-group trial, adults aged 65 years and older received a single intramuscular dose of Vimkunya (previously chikungunya virus virus-like particle vaccine) or placebo at ten sites in the USA. Participants, clinical site personnel, and the sponsor were masked to individual treatment assignments until all participants had completed their involvement in the trial and the database was cleaned and locked. Baseline and postvaccination chikungunya virus serum neutralising antibody (SNA) titres (NT80) were assessed at selected timepoints. Safety was assessed up to 183 days after dose administration in all participants from the exposed population who provided safety assessment data. This trial is registered with ClinicalTrials.gov, NCT05349617, and is completed.

Findings

Between May 12 and Dec 2, 2022, 413 participants were recruited and randomly assigned (1:1) to receive the Vimkunya vaccine (n=206) or placebo (n=207). The coprimary endpoints of immunologic superiority of chikungunya virus SNA titres compared with placebo and geometric mean titre at day 22 were met. Vimkunya induced a protective seroresponse (SNA NT80≥100, considered the presumptive seroprotective antibody response) in 149 (82%) of 181 participants (95% CI 76·1–87·2) at day 15, in 165 (87%) of 189 participants (81·8–91·3) at day 22, and in 139 (76%) of 184 participants (68·9–81·2) at day 183. Although there was a slightly higher early immune response in the 65–74 years age group at day 15 compared with the 75 years and older age group, the seroresponse rates at day 22 and day 183 were similar. There were no notable differences in adverse event rates between groups, and most adverse events were grade 1 or 2 in severity and of short duration. No vaccine-related serious adverse events or deaths occurred.

Interpretation

We provide robust data from adults aged 65 years and older showing that Vimkunya is well tolerated and can provide a high rate of protection within 2 weeks postvaccination and during 6 months of follow-up.

DOI: 10.1016/S0140-6736(25)00372-1

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00372-1/abstract