NCT04271306

Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.

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.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 5 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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).

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	Pfs25-IMX313 (10ug)/Matrix-M (50ug)	3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
BIOLOGICAL	Pfs25-IMX313 (50ug)/Matrix-M (50ug)	3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
BIOLOGICAL	Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)	2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)

Timeline

• Start date: 2021-05-25
• Primary completion: 2024-02-19
• Completion: 2024-02-19
• First posted: 2020-02-17
• Last updated: 2025-01-27

Locations

1 site across 1 country: Tanzania