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Идёт набор NCT07734649

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Фаза I / Фаза II С лечением Respiratory Syncytial Virus Immunization Human Metapneumovirus Immunization Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: RSV+HMPV vaccine, Control Vaccine 3, Control Vaccine 4, Control Vaccine 2.
Кому может быть актуально
Состояния в реестре: Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization, Healthy Volunteers. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

Обзор

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.

Вмешательства

  • Биопрепарат RSV+HMPV vaccine
    RSV + HMPV Candidate Vaccine
  • Биопрепарат Control Vaccine 3
    Control Vaccine 3
  • Биопрепарат Control Vaccine 4
    Control Vaccine 4
  • Биопрепарат Control Vaccine 2
    Control Vaccine 2
  • Другое Placebo
    Placebo
  • Биопрепарат Control Vaccine 1
    Control Vaccine 1

Первичные конечные точки

  • RSV A serum nAb (neutralizing antibodies) titers [Срок оценки: At Day 1 and Day 29]
  • RSV B serum nAb titers [Срок оценки: At Day 1 and Day 29]
  • HMPV A serum nAb titers [Срок оценки: At Day 1 and Day 29]
  • HMPV B serum nAb titers [Срок оценки: At Day 1 and Day 29]
  • Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination [Срок оценки: Within 30 minutes after vaccination]
  • Presence of solicited injection site and systemic reactions [Срок оценки: For 8 days, including the day of vaccination]
  • Presence of Unsolicited AEs [Срок оценки: For 28 days, including day of vaccination]
  • Presence of medically attended AEs (MAAEs) [Срок оценки: Within 6 months after vaccination]
  • Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs) [Срок оценки: Throughout the study (approximately 12 months)]
  • Presence of out-of-range biological test results [Срок оценки: At Day 09]
Вторичные конечные точки (8)
  • RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Срок оценки: 3, 6, 9, and 12-months post-vaccination]
  • RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Срок оценки: 3, 6, 9, and 12 months post-vaccination]
  • HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Срок оценки: 3, 6, 9, and 12 months post-vaccination]
  • HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination [Срок оценки: 3, 6, 9, and 12 months post-vaccination]
  • Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination [Срок оценки: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination]
  • Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination [Срок оценки: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination]
  • Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) [Срок оценки: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)]
  • Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) [Срок оценки: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)]

Критерии участия

Критерии включения

  • Aged 60 years or older on the day of inclusion
  • Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Критерии исключения

  • History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Previous history of Guillain-Barré Syndrome
  • Any vaccine given 4 weeks before or 4 weeks after study intervention
  • Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
  • Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
  • Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
  • Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments

The above information is not intended to contain all considerations relevant to a patient's potential participation in a 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 · 17 центров
  • Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025 — Gadsden
  • Scottsdale Clinical Trials- Site Number : 8400011 — Scottsdale
  • Long Beach Research Institute- Site Number : 8400005 — Long Beach
  • Alliance Clinical - San Diego- Site Number : 8400033 — San Diego
  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064 — DeLand
  • Accel Research Sites - NeuroStudies- Site Number : 8400063 — Decatur
  • DM Clinical Research - Chicago- Site Number : 8400050 — Melrose Park
  • DM Clinical Research - Detroit- Site Number : 8400049 — Southfield
  • … и ещё 9 центров

Идентификаторы

NCT: NCT07734649 · VCA23395 · U1111-1337-4718

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗