Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine

Официальное название

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

Обзор

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.

Вмешательства

• Препарат COVID-19 mRNA vaccine
  A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
• Препарат VYD2311
  A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
• Препарат Placebo (Normal Saline)
  A one-time dose of normal saline (placebo) administered by intramuscular injection.

Первичные конечные точки

• Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6 [Срок оценки: Through 6 days after dose]
• Assessment of systemic reactions solicited via e-diary through day 6 [Срок оценки: Through 6 days after dose]

Вторичные конечные точки (3)

• Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 56 [Срок оценки: Through 56 days after dose]
• sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56 [Срок оценки: Through 56 days after dose]
• Serum concentrations of VYD2311 through Day 56 [Срок оценки: Through 56 days after dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Invivyd Investigative Site — Overland Park

Идентификаторы

NCT: NCT07655180 · VYD2311-PREV-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗