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El ensayo clínico NCT07074665 para Malaria (Plasmodium Falciparum) está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Dose Finding Trial of R21/Matrix-M in School Children

Aún no recluta
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El ensayo clínico NCT07074665 está diseñado para estudiar la prevención de Malaria (Plasmodium Falciparum). Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se planea que el reclutamiento se inicie el 1 de octubre de 2025 hasta que el ensayo reclute a 40 participantes. Dirigido por la Universidad de Oxford, se espera que finalice el 1 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 20 de julio de 2025.
Resumen
This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso.

Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.

Título oficial

A Phase II Randomised Trial to Evaluate the Safety and Immunogenicity of a R21/Matrix-M Booster Vaccine at Two Different Doses in Burkinabe School Children

Condiciones médicas
Malaria (Plasmodium Falciparum)
Otros ID del ensayo
  • VAC101
Número del NCT
NCT07074665
Inicio del ensayo (real)
2025-10
Última actualización
2025-07-20
Fecha de finalización (estimada)
2026-12
Inscripción (prevista)
40
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Palabras clave
Malaria Vaccine
R21/Matrix-M
Objetivo principal
Prevención
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalGroup A
Participants in this arm will be given one dose of 5µg R21/50µg Matrix-M
5Μg R21/50ΜG Matrix-m
R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. The standard paediatric dose is 5µg R21/50µg Matrix-M.
ExperimentalGroup B
Participants in this arm will be given one dose of 10µg R21/50µg Matrix-M
10Μg R21/50ΜG Matrix-m
R21/Matrix-M is a vaccine against P. falciparum malaria, which has WHO prequalification and policy recommendation in children over 5 months old in malaria endemic areas. 10µg R21/50µg Matrix-M is the standard adult dose.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Reactogenicity
Reactogenicity of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso. This will be measured through: 1) the occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination and 2) the occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination.
7 days after vaccination
Safety - unsolicited AEs
Safety of an additional late booster of R21/Matrix-M at different doses, in school age children living in Burkina Faso will be assessed through the occurrence of unsolicited adverse events for 28 days following the vaccination.
28 days following vaccination
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Immunogenicity
Humoral immunogenicity by anti-CSP antibody concentrations after school age booster of R21/Matrix-M at different doses.
At baseline and one, six and twelve months after vaccination
Safety - SAEs
Serious adverse events (SAEs) following school age booster vaccination.
1 year after vaccination
Safety - deaths
Any deaths following school age booster vaccination
1 year after vaccination
Criterios de elegibilidad

Criterios de edad
Niño
Edad mínima
6 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
  • The child received four doses of R21/Matrix-M in the phase IIb study evaluating R21/MatrixM in Nanoro, Burkina Faso (VAC 076).
  • Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
  • The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
  • The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial.

  • The child is enrolled in another malaria vaccine trial.
  • The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine.
  • The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
  • The child has major congenital defects.
  • The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
  • The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
  • The child has malnutrition requiring hospital admission.
  • The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
  • Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.
  • The child has received an investigational drug or investigational vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • The child is currently participating in another clinical trial if likely to affect data interpretation of this trial.
  • The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
University of Oxford logoUniversidad de Oxford243 ensayos clínicos activos para explorar
Institut de Recherche en Sciences de la Sante, Burkina Faso logoInstitut de Recherche en Sciences de la Sante, Burkina Faso
Contactos centrales del ensayo
Contacto: Mehreen Datoo, +44 7859035715, [email protected]
1 Sitios del ensayo en 1 países
Unité de Recherche Clinique de Nanoro (URCN), Nanoro, PO Box 11 BP 218 Ouaga CMS 11, Burkina Faso
Halidou Tinto, Contacto, +226 70346354, [email protected]