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VLA15 的 2 期研究，一种针对莱姆疏螺旋体病的候选疫苗，在健康的儿童和成人研究人群中进行

2026年8月19日 更新者：Pfizer

VLA15 的安全性和免疫原性研究，一种基于多价重组 OspA 的莱姆疏螺旋体候选疫苗：一项在健康儿童和成人研究人群中进行的随机、对照、观察员盲法 2 期研究

VLA15-221是一项2期研究，将分两部分进行：主要研究阶段（A部分）和加强阶段（B部分）。 该研究将比较应用三种（0-2-6 月）或两次（0-6 月）疫苗接种的两种不同初级免疫计划的安全性和免疫原性。 在这项研究中，将包括 600 名 5-65 岁的健康受试者。 将招募具有莱姆疏螺旋体病史（先前感染疏螺旋体）的受试者以及未接触过疏螺旋体的受试者。 A 部分中每个科目的学习时间最长为 19 个月，B 部分中注册的科目的学习时间最长为 37 个月。

研究概览

地位

完全的

条件

干预/治疗

详细说明

VLA15-221是一项随机、观察者盲法、安慰剂对照、多中心2期研究，分为两部分：主要研究阶段（A部分）和加强阶段（B部分）。 在 A 部分中，将 600 名 5-65 岁的受试者按 1:1:1 分为三组：第 1 组将在第 0-2-6 个月接种 VLA15，第 2 组将在第 0-6 个月接种 VLA15，并且第 2 个月接种安慰剂，第 3 组将在第 0-2-6 个月接种安慰剂疫苗。 在 B 部分，一部分受试者将在第 18 个月接受 VLA15 或安慰剂的加强注射。

研究类型

介入性

注册 (实际的)

625

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

  • 美国
    • Connecticut
      • Bridgeport、Connecticut、美国、06606
        • New England Research Associates
      • Stamford、Connecticut、美国、06905
        • Stamford Therapeutics Consortium
      • Waterbury、Connecticut、美国、06708
        • Chase Medical Research, LLC
      • Waterbury、Connecticut、美国、06708
        • Pediatric Associates of Conn. PC
    • Minnesota
      • Minneapolis、Minnesota、美国、55402
        • Clinical Research Institute, Inc.
    • New Jersey
      • East Orange、New Jersey、美国、07018
        • Foundation Pediatrics
      • Irvington、New Jersey、美国、07111
        • Med Clinical Research Partners, LLC
    • New York
      • Binghamton、New York、美国、13905
        • Meridian Clinical Research LLC
      • Rochester、New York、美国、14609
        • Rochester Clinical Research, Inc.
      • Staten Island、New York、美国、10314
        • Richmond Behavioral Associates
      • The Bronx、New York、美国、10467
        • Advantage Clinical Trials
    • Ohio
      • Cleveland、Ohio、美国、44122
        • Velocity Clinical Research, Inc.
    • Pennsylvania
      • Erie、Pennsylvania、美国、16506
        • Allegheny Health and Wellness Pavilion
      • Erie、Pennsylvania、美国、16508
        • Liberty Family Practice
      • Fort Washington、Pennsylvania、美国、19034
        • Lockman & Lubell Pediatric Associates
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • The Miriam Hospital
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital
      • Providence、Rhode Island、美国、02903
        • Hasbro Children's Hospital
      • Warwick、Rhode Island、美国、02886
        • Velocity Clinical Research Providence

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

5年 至 65年 (孩子、成人、年长者)

接受健康志愿者

是的

描述

纳入标准：

  • 受试者在筛选当天年龄在 5 至 65 岁之间（访问 0）
  • 受试者总体健康状况良好

  • 父母/法定代表人和受试者了解研究及其程序，同意其规定

    • 对于 18-65 岁的受试者：在任何研究相关程序之前签署知情同意书
    • 对于 5-17 岁的受试者：受试者的法定代表根据当地要求签署的书面知情同意书，如果适用，在任何研究相关程序之前签署受试者的书面知情同意书。

  • 如果受试者有生育潜力：受试者在筛选时血清妊娠试验呈阴性（访问 0），并同意根据以下时间表采取适当的节育措施：

    • 主要研究阶段：整个研究的持续时间
    • 加强阶段：直到第 23 个月（即加强剂量后 5 个月）
  • 受试者愿意并能够遵守预定的就诊、治疗计划和其他研究程序
  • 受试者在研究期间可以使用，并且可以在研究参与期间通过电话联系

排除标准：

  • 受试者患有与莱姆疏螺旋体病 (LB) 相关的慢性疾病、活动性有症状的 LB，或在第 1 天之前的最后 3 个月内接受过 LB 治疗；
  • 受试者之前接受过 LB 疫苗接种；
  • 受试者在第 1 天之前的 4 周内被蜱叮咬过；
  • 受试者有病史或目前患有临床相关疾病；
  • 受试者有或目前患有神经炎症或自身免疫性疾病的病史；
  • 受试者在第 1 天之前的 3 周内患有已知的血小板减少症、出血性疾病或接受过抗凝剂治疗；
  • 受试者在第 1 天之前的 4 周内接受过主动或被动免疫；
  • 受试者在第 1 天接种疫苗前 4 周内在另一项临床试验中接受过任何其他注册或未注册的医药产品；
  • 受试者有已知或疑似免疫系统缺陷或在第 1 天前 4 周内接受过免疫抑制治疗；
  • 受试者有不明原因的过敏反应或不明原因的严重过敏反应史，或对疫苗的一种成分有已知的超敏反应或过敏反应；
  • 受试者在过去 5 年内有任何恶性肿瘤；
  • 受试者怀孕，计划在研究过程中怀孕或在入学时正在哺乳期；
  • 受试者在第 1 天前 4 周已经献血或计划献血或献血制品；
  • 受试者有任何可能损害其健康、可能干扰研究终点评估或会限制受试者完成研究的能力的情况；
  • 主体处于依赖关系；

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：A+B 部分 - 第 1 组
A 部分：第 0、2 和 6 个月的 VLA15 B 部分：第 18、30 和 42 个月的 VLA15
生物：VLA15
基于多价重组外表面蛋白 A (OspA) 的候选疫苗
实验性的：A+B 部分 - 第 2 组
A 部分：第 0 个月和第 6 个月使用 VLA15，第 2 个月使用安慰剂 B 部分：第 18、30 和 42 个月使用 VLA15
生物：VLA15
基于多价重组外表面蛋白 A (OspA) 的候选疫苗
生物：安慰剂
PBS（磷酸盐缓冲盐水）
安慰剂比较：A+B 部分 - 第 3 组
A 部分：第 0、2 和 6 个月的安慰剂 B 部分：第 18、30 和 42 个月的安慰剂
生物：安慰剂
PBS（磷酸盐缓冲盐水）

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
Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
大体时间：From Day 1 to Day 7 after vaccination 1 at Month 0
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 at Month 0
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
大体时间：From Day 1 to Day 7 after vaccination 2 at Month 2
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 at Month 2
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
大体时间：From Day 1 to Day 7 after vaccination 3 at Month 6
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 at Month 6
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
大体时间：From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase
大体时间：At Day 208 (Month 7)
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure.
At Day 208 (Month 7)

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 1 Booster Dose
大体时间：From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 1 booster dose at Month 18
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 Booster Dose
大体时间：From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 2 booster dose at Month 30
Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 Booster Dose
大体时间：From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.
From Day 1 to Day 7 after vaccination 3 booster dose at Month 42
Percentage of Participants With Serious Adverse Events (SAEs)
大体时间：From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
大体时间：From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate.
From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)
Percentage of Participants With Unsolicited AE
大体时间：Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively
Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
大体时间：SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 5-11, 12-17 and 18-65 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.
SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18
大体时间：Baseline; Days 85, 180 and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Baseline; Days 85, 180 and 365; Month 18
Seroconversion Rate (SCR) at Days 85, 180, 208, 365 and Month 18
大体时间：Days 85, 180, 208 and 365; Month 18
Seroconversion for enzyme linked immunosorbent assay (ELISA) was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a greater than or equal to (>=) 4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Days 85, 180, 208 and 365; Month 18
Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208
大体时间：Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18
大体时间：Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. Day 194 data was reported for adult participants only as pre-specified in protocol.
Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18
SCR Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18
大体时间：Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. Day 194 data was reported for adult participants only as pre-specified in protocol.
Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18
GMFR for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208
大体时间：Days 85 and 208
GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 and 18-65 years) determined by IgG binding assay at Day 85 and Day 208 were evaluated.
Days 85 and 208
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
大体时间：Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
大体时间：Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 31 and 43 During the Booster Phase
大体时间：Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43
GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
大体时间：Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
SCR Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
大体时间：Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a >=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.
Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48
GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 31 and 43 During the Booster Phase
大体时间：Months 19, 31 and 43
GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6), stratified by age group (5-11, 12-17 and 18-65 years) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.
Months 19, 31 and 43

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

Pfizer

合作者

Valneva Austria GmbH

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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

有用的网址

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)

2021年3月8日

初级完成 (实际的)

2022年3月25日

研究完成 (实际的)

2025年7月2日

研究注册日期

首次提交

2021年3月8日

首先提交符合 QC 标准的

2021年3月15日

首次发布 (实际的)

2021年3月17日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • VLA15-221
  • C4601008 (其他标识符：Alias Study Number)

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

辉瑞将提供对个人去识别参与者数据和相关研究文件（例如 协议、统计分析计划 (SAP)、临床研究报告 (CSR)）根据合格研究人员的要求，并遵守某些标准、条件和例外情况。 有关辉瑞数据共享标准和请求访问流程的更多详细信息，请访问：https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。

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

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