Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04318002
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2020-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: