R21/MM Dosing, Presentations, and Preservatives
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: 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free, 5μg R21/50μg Matrix-M with 2PE preservative.
- Кому может быть актуально
- Состояния в реестре: Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction. Базовые параметры: 14 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
- Bangladesh
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
Обзор
This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. All participants will receive the same number of injections and will be randomly assigned to receive one of the followings: * Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125). * Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125) * Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125) Clinical procedure for participants: * Standardized symptom questionnaire * Physical examination: Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential) * Venous blood collection (Pre-vaccination) 3mL * Vaccination
Подробное описание
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
Вмешательства
- Биопрепарат 10μg R21/50μg Matrix-M
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125) - Биопрепарат 5μg R21/50μg Matrix-M with adaptor preservative free
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125) - Биопрепарат 5μg R21/50μg Matrix-M with 2PE preservative
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)
Первичные конечные точки
- The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody) [Срок оценки: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).]
- The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen [Срок оценки: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).]
Вторичные конечные точки (2)
- Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M [Срок оценки: At Month 1, Month 2, Month 3, Month 11 and Month 12]
- Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative. [Срок оценки: At Month 1, Month 2, Month 3, Month 11 and Month 12]
Критерии участия
Критерии включения
- Residence in a study village for the study period, i.e. 12 months.
- Age 14 years to 60 years.
- Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).
Критерии исключения
- Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
- Acute illness requiring intervention.
- A history of an adverse reaction to study vaccine.
- Prior receipt of any other malaria vaccine.
- Enrolment in another intervention trial in the last month.
- Planned enrolment in another intervention trial in the coming 12 months.
- Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.
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
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Bangladesh · 2 центра
- Alikadam Upazila Health Complex — Bāndarban
- Lama Upazila Health Complex — Lāma
Идентификаторы
NCT: NCT07194668 · MAL25005