NCT04318002

Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania

A Phase Ib Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Plasmodium Falciparum Malaria Vaccine Candidate RH5.1/Matrix-M in Healthy Adults and Infants in Tanzania

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Months – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	RH5.1/Matrix-M	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)

Timeline

• Start date: 2021-01-21
• Primary completion: 2023-08-27
• Completion: 2023-08-27
• First posted: 2020-03-23
• Last updated: 2024-11-22

Locations

1 site across 1 country: Tanzania