Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320535
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-12
Brief Title:
A Phase 1 Study to Assess an Escalating Dose Multi-prime Vaccination Schedule of R21Matrix-M
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase 1 Study to Assess the Safety and Immunogenicity of R21Matrix-M Administered in an Escalating Dose Multi-prime Vaccination Schedule in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-02
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 a phase I clinical study that aims to assess the safety and immunogenicity of a novel escalating dose regimen of R21Matrix-M in healthy malaria-naïve adults
Detailed Description:
This is a study to assess safety and immunogenicity of a novel dosing regimen for R21 Matrix-M a leading Plasmodium falciparum malaria vaccine in healthy malaria-naïve adults Participants in the study will receive either 6 escalating doses groups 1 and 2 or 2 standard doses group 3 of R21 Matrix-M all delivered in the same arm Up to 36 volunteers will be enrolled and followed up for 12-24 months after their first vaccine
In addition to blood sampling throughout the follow-up period participants will undergo fine needle aspiration of axillary lymph nodes twice during the study to allow further characterisation of immune responses to this novel vaccine regimen
In addition to blood sampling throughout the follow-up period participants will undergo fine needle aspiration of axillary lymph nodes twice during the study to allow further characterisation of immune responses to this novel vaccine regimen
Study Oversight
Has Oversight DMC:
None
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?:
None