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Набор скоро начнётся NCT07455318

Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.

Фаза III С лечением Rabies (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: Booster vaccination.
Кому может быть актуально
Состояния в реестре: Rabies (Healthy Volunteers). Базовые параметры: 18 лет — 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
Бельгия
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 Multicentre, Open-label Trial in Healthy Volunteers to Assess the Boostability of Three Different Rabies Pre-exposure Prophylaxis Regimens When Administering a Single-dose, Intramuscular Vaccination as Simulated Post-exposure Prophylaxis at Least Five Years Following Priming.

Обзор

A multicentre, open label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens (2 x 1IM regimen, 2 x 2 ID regimen, 1 x 2 ID regimen) when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming.

Подробное описание

This multicentre clinical trial will include 561 participants, allocated evenly across 3 groups (187 per group). Participants are assigned to one of three groups according to their prior PrEP regimen, provided their last dose was given at least 5 years prior to enrollment.

• Group 1: 21IM regimen, (N = 187): received PrEP at least 5 years ago through 1 x 1,0 mL IM injection (Day 0 and Day 7), with a 7-day interval between visits (interval of 5 to 56 days is allowed).

• Group 2: 2²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections (Day 0 and Day 7) with a 7-day interval between visits (interval of 5 to 56 days is allowed).

• Group 3: 1²ID regimen (N = 187): received PrEP at least 5 years ago through 2 x 0,1 mL ID injections on Day 0

All subjects will receive 1 x 1,0 mL IM injection of purified chick-embryo cell-culture rabies vaccine as sPEP (booster) at least five years after primary vaccination (PrEP).

Neutralizing antibody titers against rabies virus will be measured using the Rapid Fluorescent Focus Inhibition Test (RFFIT) on Day 0 (before administration of sPEP) and on Days 7 and 14 after sPEP vaccination.

A titre of ≥ 0.5 IU/mL is defined as adequate (WHO standard).

Вмешательства

  • Биопрепарат Booster vaccination
    To investigate whether the boostability of a (A) two-visit IM, (B) two-visit ID and (C) one-visit ID pre-exposure vaccination regimen is non-inferior to a theoretical 99% boostability by administering a single-dose IM booster to simulate exposure to rabies at least 5 years after the pre-exposure regimens regimen.

Первичные конечные точки

  • Primary: boostability [Срок оценки: 13 months - from First Patient In (FPI) to Last Patient Out (LPO)]
Вторичные конечные точки (7)
  • RFFIT levels ≥ 0.5 IU/mL Day 14 [Срок оценки: 14 days following booster vaccination]
  • FFIT levels ≥ 0.5 IU/mL on the day of the booster (Day 0). [Срок оценки: Day 0 - on day of booster vaccination]
  • RFFIT levels ≥ 3.0 IU/mL on Day 7 after the booster [Срок оценки: Day 7 - following booster vaccination]
  • RFFIT levels ≥ 3.0 IU/mL on Day 14 after the booster. [Срок оценки: Day 14 after the booster vaccination]
  • RFFIT levels ≥ 10 IU/mL on Day 7 after the booster. [Срок оценки: Day 14 following the booster vaccination]
  • RFFIT levels ≥ 10 IU/mL on Day 14 after the booster. [Срок оценки: Day 14 following the booster vaccination.]
  • Safety objectives [Срок оценки: 1. & 2. Day 7 following the booster vaccination. 3. 13 months - entire study duration FPI to LPO]

Критерии участия

Критерии включения

  • ≥ 18 to ≤ 60 years of age at time of inclusion
  • Willingness to provide written informed consent
  • Having received PrEP with a 21IM, 2²ID or 1²ID regimen at least 5 years before starting the study. For 21IM and 2²ID interval of 5 days to 56 days between the 2 visits is allowed.

Критерии исключения

  • Known allergy to one of the components of the vaccine.
  • Subjects, who received immunomodulating therapy within the last 3 months (12 weeks).

Note: See Section 6.3 for detailed guidance on immunomodulating therapies.

  • Planned vaccination with any inactivated vaccine within 2 weeks before or after vaccination in the study or with any live attenuated vaccine within 1 month before or after each vaccination in the study.
  • Ongoing pregnancy or active child wish at the time of booster vaccination (D0).
  • Any other PrEP rabies vaccine schedule/vaccination than mentioned in the inclusion criteria.
  • Previous rabies (s)PEP
  • Inability or unwillingness to comply with study procedures, including protocol-defined visits, assessments, or interventions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Бельгия · 6 центров
  • Clinical Trial Site Insitute of Tropical Medicine — Antwerp
  • Cliniques Universitaires de Saint Luc — Brussels
  • Centrum voor vaccinologie (CEVAC) — Ghent
  • UZ Brussel — Jette
  • Centre Hospitalier Universitaire de Liège — Liège
  • Military Hospital Queen Astrid — Neder-Over-Heembeek

Идентификаторы

NCT: NCT07455318 · BAZOOKA_221 · 2025-524765-24-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗