A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania
This study aims to evaluate safety, immunogenicity, and transmission blocking activity of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria in Bagamoyo district, Tanzania. The study will enrol 45 volunteers comprising of 13 adults (18-45 years) and 32 children (5-12 years).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)
Ifakara Health Institute Clinical Trial Facility
Bagamoyo, Tanzania
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination).
Time frame: Assessment of solicited symptoms in the first 7 days post vaccination
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days).
Time frame: Assessment of unsolicited symptoms in the first 30 days post vaccination
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of serious adverse events throughout the study period.
Time frame: Assessment of SAEs until the end of the study (approx 2 years)
Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.
Pfs25 antibody levels elicited by Pfs25IMX313-Matrix-M as measured by ELISA at each time point where serology samples are analysed.
Time frame: Duration of the study (approx 2 years)
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Transmission blocking activity (TBA) of induced antibody as measured in standard membrane feeding assays (SMFA) and Direct Membrane feeding assays (DMFA).
Time frame: Duration of the study (approx 2 years)
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Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Correlation of TBA with antibody levels at each time point where the membrane feeding assays are conducted.
Time frame: Duration of the study (approx 2 years)
Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
The vaccination schedule that lead to the highest peak and duration of anti-Pfs25 antibody response post vaccination, and the highest transmission blocking activity (TBA) as measured by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
Time frame: Duration of the study (approx 2 years)