Dose Finding Trial of R21/Matrix-M in School Children
ConditionMalaria (Plasmodium Falciparum)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-8
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
5µg R21/50µg Matrix-M
Biological/VaccineR21/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.
10µg R21/50µg Matrix-M
Biological/VaccineR21/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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
7 days after vaccination2
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.
Time frame
28 days following vaccinationSecondary outcomes
1
Immunogenicity
Humoral immunogenicity by anti-CSP antibody concentrations after school age booster of R21/Matrix-M at different doses.
Time frame
At baseline and one, six and twelve months after vaccination2
Safety - SAEs
Serious adverse events (SAEs) following school age booster vaccination.
Time frame
1 year after vaccination3
Safety - deaths
Any deaths following school age booster vaccination
Time frame
1 year after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborator
Source ClinicalTrials.gov