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Last Updated: 30/04/2024
Safety and immunogenicity of Rh5.1/Matrix-M in healthy adults and infants in Tanzania
Objectives
The objective of this study is to study the safety and immunogenicity of RH5.1/Matrix-M, administered intramuscularly in healthy adults, young children and infants in Tanzania.
This is an age de-escalation, dose-escalation open label randomized trial. 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 2-2.5 years after the first vaccination with RH5.1/Matrix-M vaccination. The duration of the entire study will be 2-2.5 years per participant from the time of first vaccination.
Study type: Interventional
Enrollment: 60 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Sequential assignment
Masking: Open label
NCT number: NCT04318002
Phase: Phase Ib
Jan 2021 — Jul 2023
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