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VLA1553 在 1 至 11 岁健康儿童中的剂量反应 2 期临床研究

2026年7月21日 更新者：Valneva Austria GmbH

一项随机、观察者盲法剂量反应第 2 期研究，旨在评估两种不同剂量水平的基孔肯雅病毒候选减毒活疫苗 (VLA1553) 在 1 至 11 岁健康儿童中的安全性和免疫原性

这是一项多中心、前瞻性、随机、观察者盲法、三组、2期临床研究，评估VLA1553的全剂量制剂、VLA1553的半剂量制剂和对照。

将招募至少 300 名 1 至 11 岁的男性和女性健康儿童，参与者的总体分配比例为 2:2:1，分为两个 VLA1553 剂量组（每组 120 名）或对照组（n=60 名）。

研究概览

地位

完全的

条件

干预/治疗

详细说明

这是一项多中心、前瞻性、随机、观察者盲法、三臂、2 期临床研究，评估 VLA1553 的全剂量制剂、VLA1553 的半剂量制剂和对照（Nimenrix，一种四价脑膜炎球菌疫苗 - Men ACWY）。

将招募至少 300 名 1 至 11 岁的男性和女性健康儿童，参与者的总体分配比例为 2:2:1，分为两个 VLA1553 剂量组（每组 120 名）或对照组（Nimenrix）（n=60 名） ）。

作为一项安全预防措施，前 30 名哨点参与者将根据年龄递减计划以开放标签的方式纳入该研究。

哨点分析后，参与者将以盲法、随机的方式被纳入三个研究组。 在每个治疗组中，参与者将被分为三个年龄层：

A层：7至11岁——从7岁生日到12岁生日前一天的儿童。

B 层：3 至 6 岁 - 从 3 岁生日到 7 岁生日前一天的儿童。

C 层：1 至 2 岁 - 从 1 岁生日到 3 岁生日前一天的儿童。

VLA1553 治疗组的年龄层目标是大小相等，即每个年龄层大约 40 人。

研究类型

介入性

注册 (实际的)

304

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 多明尼加共和国
      • Santo Domingo、多明尼加共和国、10306
        • Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP
    • Gazcue
      • Santo Domingo、Gazcue、多明尼加共和国
        • Fundacion Dominicana de Perinatologia Fundacion Probebe
  • 洪都拉斯
      • Tegucigalpa、洪都拉斯
        • Inversiones en Investigacion Medica INVERIME

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

纳入标准：

  1. 接种疫苗时 A 层年龄为 7 至 11 岁12、B 层年龄为 3 至 6 岁13、C 层年龄为 1 至 2 岁14 的男性或女性健康儿童；
  2. 根据当地要求，参与者父母/合法可接受代表 (LAR) 的书面知情同意书，以及参与者的书面知情同意书（如果适用）；

排除标准：

  1. IgM+/IgG- 的参与者没有资格参与本研究。
  2. 参与者正在服用药物或其他治疗来治疗因先前 CHIKV 感染而导致的未解决的症状；或已参与涉及研究性 CHIKV 疫苗的临床研究；
  3. 参与者患有急性或近期感染（并且在筛选访视前一周内并非无症状（访视 0）

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：VLA1553全剂量
生物：VLA1553全剂量
第一天单次肌肉注射 VLA1553 全剂量疫苗，这是一种冻干基孔肯雅热减毒活疫苗候选品
实验性的：VLA1553半剂量
生物：VLA1553半剂量
第一天单次肌肉注射半剂量 VLA1553（一种冻干基孔肯雅热减毒活疫苗）
有源比较器：控制
第一天单次肌肉注射 Nimenrix（男性 ACWY 疫苗），这是一种用于主动免疫的结合疫苗
生物：控制
尼门里克斯

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Solicited Injection Site Reactions
大体时间：within 14 days post-vaccination
Frequency and severity of solicited injection site and solicited systemic reactions within 14 days post-vaccination.
within 14 days post-vaccination
Severity of Solicited Injection Site Reactions
大体时间：within 14 days post-vaccination
within 14 days post-vaccination
Number of Participants With Solicited Systemic Reactions
大体时间：within 14 days post-vaccination
within 14 days post-vaccination
Severity of Solicited Systemic Reactions
大体时间：within 14 days post-vaccination
within 14 days post-vaccination

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Any Adverse Event (AE)
大体时间：within 28 days post-vaccination
within 28 days post-vaccination
Severity of Any Adverse Event (AE)
大体时间：within 28 days post-vaccination
In the Outcome measure "Severity of any AE", subjects may be represented in more than one AE category. Therefore, the total number of subjects with any AE may be lower than the sum of the numbers of subjects in the individual AE categories (solicited / unsolicited AE).
within 28 days post-vaccination
Number of Participants With of Unsolicited AE
大体时间：until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Severity of Unsolicited AE
大体时间：until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Number of Participants With Any Serious Adverse Event (SAE)
大体时间：until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
Number of Participants With Any Early Onset Adverse Event of Special Interest (AESI)
大体时间：2 to 21 days post-vaccination

Early onset AESI were defined as:

  1. Fever (≥ 38.0 °c / 100.4 °f,) AND
  2. symptoms suggesting acute (poly)arthralgia/arthritis, myalgia, neurological symptoms (e.g., for meningoencephalitis, acute encephalitis, headache, seizures), back pain, lymphadenopathy, cardiac or ocular symptoms (e.g., for uveitis and retinitis); OR one or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus [foot plant]), pigmentary changes, bullous rash/ skin blistering, purpura, ecchymosis and
  3. Onset of symptoms 2 to 21 days after vaccination AND
  4. Duration of event ≥ 3 days.
2 to 21 days post-vaccination
Severity of Any Early Onset Adverse Event of Special Interest (AESI)
大体时间：2 to 21 days post-vaccination
2 to 21 days post-vaccination
Number of Participants With Any Late Onset Adverse Event of Special Interest (AESI)
大体时间：Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
Severity of Any Late Onset Adverse Event of Special Interest (AESI)
大体时间：Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
Assessment of Viremia on Days 1, 4, 8 and 15
大体时间：on Days 1, 4, 8 and 15 and beyond as applicable

Number of participants with viremic results, including quantifiable results and results below LLOQ, by visit and by pooled trial arm. Day 29 was only tested, if Day 15 was tested positive.

Viremia is measured in genome copy equivalents per milliliter (GCE/mL). All quantifiable results and results below LLOQ (< 3214.4 GCE/mL), but above the LOD, are considered "viremic". A result of "not detected" or below LOD (<1071,4 GCE/mL) is included as "non-viremic".
on Days 1, 4, 8 and 15 and beyond as applicable
Immune Response in Baseline Seronegative Participants as Measured by CHIKV-specific Neutralizing Antibody Titers
大体时间：on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Immune Response provided by Geometric Mean Titers (GMTs) in Baseline Seronegative Participants pooled by Trial Arm up to 12 months post vaccination.
on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers by Age Group and Trial Arm.
大体时间：on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Immune Response provided by Geometric Mean Titers (GMTs) by Visit, by Age Group and Trial Arm up to 12 months post vaccination.
on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers Pooled by Dose
大体时间：on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Immune Response provided by Geometric Mean Titers (GMTs) by Visit, pooled by Trial Arm up to 12 months post vaccination.
on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants Seronegative at Baseline With Seroconversion as Compared to Baseline
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of participants seronegative at baseline with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Seropositive at Baseline With Seroconversion as Compared to Baseline
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of participants seropositive at baseline with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm.
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants With Seroconversion as Compared to Baseline Stratified by Age Stratum
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of participants with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit by Age Group and Trial Arm.
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants With Seroconversion as Compared to Baseline by Dose
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of participants with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Seronegative at Baseline With a Seroresponse (Defined as PRNT50 ≥150 for Baseline Negative Participants) by Dose
大体时间：on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm.
on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants With a Seroresponse Stratified by Age Stratum
大体时间：on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit by Age Group and Trial Arm.
on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants With a Seroresponse Stratified by Dose
大体时间：on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm.
on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Participants Seronegative at Baseline
大体时间：at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seronegative Participants by Visit Pooled by Trial Arm.
at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline in Seropositive Participants
大体时间：at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seropositive Participants by Visit Pooled by Trial Arm.
at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Age Stratum
大体时间：at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit by Age Group and Trial Arm.
at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change of CHIKV-specific Neutralizing Antibody Titers as Compared to Baseline Stratified by Dose
大体时间：at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit Pooled by Trial Arm.
at Days 15, 29, 85, 180 and at Month 12 post-vaccination
Percentage of Participants Seronegative at Baseline Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline Stratified by Age Stratum
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit by Age Group and Trial Arm.
at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by Dose
大体时间：at Day 15, Day 29, Day 85, Day 180 and Month 12
Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
at Day 15, Day 29, Day 85, Day 180 and Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Valneva Austria GmbH

调查人员

  • 学习椅：Valneva Clinical Development、Valneva Austria GmbH

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年12月18日

初级完成 (实际的)

2024年7月31日

研究完成 (实际的)

2025年7月2日

研究注册日期

首次提交

2023年10月24日

首先提交符合 QC 标准的

2023年10月24日

首次发布 (实际的)

2023年10月30日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2025年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VLA1553-221

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

审判完成后，Valneva可以提供对单个被识别的参与者数据和相关试验文件的访问（例如 协议，统计分析计划（SAP），临床试验报告（CTR），应合格研究人员的要求，并得到Valneva的审查和批准。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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