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Идёт набор NCT06843317

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

Фаза I С лечением RSV Infection

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: Candidate vaccine, SCB-1019T, AREXVY, placebo.
Кому может быть актуально
Состояния в реестре: RSV Infection. Базовые параметры: 60 лет — 85 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, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before

Обзор

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

Подробное описание

The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

Вмешательства

  • Биопрепарат Candidate vaccine, SCB-1019T
    SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.
  • Биопрепарат AREXVY
    positive comparator
  • Другое placebo
    Placebo Comparator

Первичные конечные точки

  • To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine [Срок оценки: Within 7 days after vaccination]
  • To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine [Срок оценки: Within 28 days after vaccination]
  • To evaluate the safety and reactogenicity of revaccination with SCB-1019T vaccine [Срок оценки: Throughout the study period, from enrollment to 6 months follow up]

Критерии участия

Критерии включения

  • Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
  • Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
  • Individuals willing and able to give an informed consent, prior to screening.
  • Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Критерии исключения

  • Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
  • Recurrent or un-controlled neurological disorders or seizures.
  • Serious or unstable chronic illnesses
  • Any history of dementia or any medical condition that moderately or severely impairs cognition
  • History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

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
Четверное слепое
Основная цель
Профилактика

Центры проведения

США · 5 центров
  • AMR Phoenix — Phoenix
  • AMR Fort Myers — Fort Myers
  • AMR Lexington — Lexington
  • AMR Kansas City — Kansas City
  • Knoxville — Knoxville

Идентификаторы

NCT: NCT06843317 · CLO-SCB-1019-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗