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. This trial is co-funded by the Serum Institute of India and Coefficient Giving.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
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.
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.
Unité de Recherche Clinique de Nanoro (URCN)
Nanoro, Burkina Faso
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 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.
Time frame: 28 days following vaccination
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 vaccination
Safety - SAEs
Serious adverse events (SAEs) following school age booster vaccination.
Time frame: 1 year after vaccination
Safety - deaths
Any deaths following school age booster vaccination
Time frame: 1 year after vaccination
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