Идёт набор NCT06776692

Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

— Наблюдательное Dengue Vaccines

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: Qdenga.
Кому может быть актуально: Состояния в реестре: Dengue Vaccines. Базовые параметры: от 4 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: Италия
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

Characterisation of Dengue Vaccine (Qdenga®, TAK-003)-Induced Humoral and Cellular Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

Обзор

The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees. Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.

Подробное описание

This is a non-profit, single-center, drug-based observational study whose primary objective is to characterize dengue-specific humoral and cellular immunity induced by the Qdenga® vaccine in vaccinees.

The study involves the enrollment of all pediatric subjects (age ≥ 4 years) and adults who present themselves at the DITM travel clinic for the administration of the Dengue vaccine; 402 patients are expected to be enrolled and will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years (T4). The samples thus collected will be analyzed for the characterization of innate immunity, the characterization of cellular immunity and the characterization of the humoral response.

Вмешательства

Препарат Qdenga
Administration of Dengue vaccine and blood sample collection

Первичные конечные точки

Anti-DENV antibodies [Срок оценки: BEFORE administration of the first dose (Time 0 = T0), immediately BEFORE the second dose (Time 2 = T2) of vaccine, and one to two months after the second dose (Time 3 = T3)]

Вторичные конечные точки (5)

Innate immunity response [Срок оценки: BEFORE administration of the first dose (T0), after 24-48h after the first dose (Time 1 = T1)]
Cellular response [Срок оценки: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)]
Quantitative and qualitative anti-DENV antibody response [Срок оценки: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)]
Humoral response [Срок оценки: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)]
Cell mediated response [Срок оценки: At the moment of the administration of the first dose (T0), immediately before the second dose (T2), and one to two months after the second dose (T3)]

Критерии участия

Критерии включения

Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.
Age >= 4 years.
Signed informed consent.