Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine (LIBERTY)
2026年6月12日 更新者:Invivyd, Inc.
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Serum Virus Neutralizing Antibody Responses, and Pharmacokinetics of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants.
This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently.
Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.
研究概览
研究类型
介入性
注册 (估计的)
210
阶段
- 第三阶段
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。
学习联系方式
- 姓名:Study Inquiry
- 电话号码:+1 781-819-0080
- 邮箱:clinicaltrials@invivyd.com
学习地点
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Kansas
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Overland Park、Kansas、美国、66212
- 招聘中
- Invivyd Investigative Site
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接触:
- Study Inquiry
- 电话号码:781-819-0080
- 邮箱:clinicaltrials@invivyd.com
-
-
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
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
- Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
- Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, and ECG per study site standard operating procedures.
Exclusion Criteria:
- Prior receipt of VYD2311 or pemivibart (VYD222).
- Prior receipt of a COVID-19 vaccine within 6 months before Day 0 and prior receipt of a non-COVID-19 vaccine within 28 days before Day 0.
- Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.
- Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.
- Tests positive for current SARS-CoV-2 infection by RAT or local nucleic acid amplification test (eg, RT-PCR) on Day 0.
- Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 0.
- Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in the opinion of the investigator or has a fever ≥38oC (≥100.4oF) within 14 days of Day 0.
- Any chronic or significant medical condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety or study results.
NOTE: The above information is not intended to contain all considerations relevant to a participant's potential eligibility in the clinical trial.
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:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections
Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations
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A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
A one-time dose of normal saline (placebo) administered by intramuscular injection.
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有源比较器:Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections
Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations
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A one-time dose of normal saline (placebo) administered by intramuscular injection.
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
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有源比较器:Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections
Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations
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A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
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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 |
|---|---|---|
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Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6
大体时间:Through 6 days after dose
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Through 6 days after dose
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Assessment of systemic reactions solicited via e-diary through day 6
大体时间:Through 6 days after dose
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To compare the systemic reaction of VYD2311 (study drug) with a COVID-19 vaccine when administered alone or concurrently in healthy adults.
E-diaries will solicit participant reported systemic reactions including vomiting, fever, diarrhea, headache, fatigue, chills, myalgia, and arthralgia.
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Through 6 days after dose
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 56
大体时间:Through 56 days after dose
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Through 56 days after dose
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sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56
大体时间:Through 56 days after dose
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Through 56 days after dose
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Serum concentrations of VYD2311 through Day 56
大体时间:Through 56 days after dose
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Through 56 days after dose
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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。
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)
2026年6月8日
初级完成 (估计的)
2026年8月1日
研究完成 (估计的)
2026年8月1日
研究注册日期
首次提交
2026年6月8日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6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
- VYD2311-PREV-003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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
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.