Assessing the safety, immunogenicity and ex-vivo efficacy of two transmission blocking vaccines (Pfs25-IMX313 in Matrix M and Pfs48/45 in Matrix M alone and co-administered) in Burkina Faso, in 18-45 years, 12-17 years and 05-11 year olds.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
56
Two soluble protein vaccines.
Institut des Sciences et Techniques (INSTech)
Bobo-Dioulasso, Burkina Faso
To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria.
Occurrence of solicited local and systemic reactogenicity signs and symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3, 5 and 6 after vaccination). * Occurrence of unsolicited adverse events (AE) including safety laboratory measures for 28 days following each vaccination * Occurrence of serious adverse events (SAEs) during the whole study duration * Occurrence of AEs of special interest (AESIs) during the whole study duration
Time frame: Through study completion, an average of 8 months from enrollment
To determine the Pfs25 and Pfs48/45 humoral immune response
Pfs25 and Pfs48/45 antibody levels elicited by Pfs25IMX313-Matrix-M and Pfs48/45 in Matrix-M as measured by ELISA at Days 0, 14, 28, 42, 56, 72, 140, 236
Time frame: Through study completion, an average of 8 months from enrolment
To determine the ex-vivo functional transmission blocking activity of Pfs25 and Pfs48/45 administered alone and in combination
Standard membrane feeding assays (SMFA) and direct membrane feeding assays (DMFA) at Days 0, 14, 28, 42, 56, 72, 140, 236, reported as a percentage of transmission reducing activity compared to controls (% TRA).
Time frame: Through study completion, an average of 8 months from enrolment
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