This is an age de-escalation, dose-escalation open label randomised trial studying the safety and immunogenicity of RH5.1/Matrix-M, administered intramuscularly in healthy adults, young children and infants in Tanzania
A total of 60 participants will be enrolled consisting of healthy adults (18-45 years) and infants (5-17 months) residing in Bagamoyo district, Tanzania. Participants will be recruited from areas of low malaria transmission in Bagamoyo town and areas of high malaria transmission within Bagamoyo district. All participants will be followed for 2-2.5years after the first vaccination with RH5.1/Matrix-M vaccination. The duration of the entire study will be 2-2.5years per participant from the time of first vaccination. The trial is funded by EDCTP (reference: RIA2016V-1649 MMVC). The paper containing this trial's results is available at: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00312-8/fulltext
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
3 doses of RH5.1/Matrix-M at different concentrations: RH5.1(10µg)/Matrix-M (50µg), RH5.1(50µg)/ Matrix-M (50µg), RH5.1(10µg)/ Matrix-M (25µg), RH5.1(50µg)/ Matrix-M (25µg)
Ifakara Health Institute Clinical Trial Facility
Bagamoyo, Tanzania
Safety of RH5.1-Matrix-M given in 3 doses in healthy Tanzanian adults and children naturally exposed to malaria as assessed by the occurrence of solicited symptoms.
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period.
Time frame: Assessment of solicited symptoms in the first 7 days post vaccination
Safety of RH5.1-Matrix-M given in 3 doses in healthy Tanzanian adults and children naturally exposed to malaria as assessed by the occurrence of unsolicited symptoms.
Occurrence of unsolicited symptoms after each vaccination during a 28-day surveillance period (day of vaccination and 28 subsequent days).
Time frame: Assessment of unsolicited symptoms in the first 30 days post vaccination
Safety of RH5.1-Matrix-M given in 3 doses in healthy Tanzanian adults and children naturally exposed to malaria as assessed by the occurrence of serious adverse events.
Occurrence of serious adverse events throughout the study period.
Time frame: Assessment of SAEs until the end of the study (approx 2 years)
Anti-RH5 antibody concentration by ELISA
Evaluation of the magnitude of antibody responses to RH5 in adults, children and infants residing in a malaria endemic country, as measured by ELISA
Time frame: Through study completion (approx 2 years)
Growth inhibition activity of IgG from vaccinees on a panel of P. falciparum parasites
Evaluation of the quality of antibody responses to RH5 in adults, children and infants residing in a malaria endemic country, as measured by an assay of growth inhibition activity on the vaccinees' sera
Time frame: Through study completion (approx 2 years)
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Avidity of anti-RH5 antibodies by ELISA and/or other assays (to be defined)
Evaluation of the avidity of antibody responses to RH5 in adults, children and infants residing in a malaria endemic country, as measured by ELISA
Time frame: Through study completion (approx 2 years)
Cellular immune responses to the RH5 by ELISpot assay and/or Flow cytommetry
Evaluation of the magnitude and quality of cellular immune responses to PfRH5 in adults, children and infants residing in a malaria endemic country, by ELISpot assay and/or Flow cytommetry
Time frame: Through study completion (approx 2 years)