Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02532049
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2015-08-07
Brief Title:
A Clinical Trial to Assess the Safety and Immunogenicity of New Malaria Vaccine Candidates ChAd63 Pfs25-IMX313 and MVA Pfs25-IMX313
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase Ia Clinical Trial to Assess the Safety Immunogenicity and Ex-vivo Efficacy of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 Pfs-IMX313 Alone and With MVA Pfs25-IMX313
Status:
COMPLETED
Status Verified Date:
2017-07
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 clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines ChAd Pfs-IMX313 will either be administered alone or with MVA Pfs25-IMX313 in a prime-boost regime
All vaccines will be administered intramuscularly
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x109 vp
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x1010 vp
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x1010 vp and one dose of MVA Pfs25-IMX313 at 1x108 pfu eight weeks later
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x1010 vp and one dose of MVA Pfs25-IMX313 at 2x108 pfu eight weeks later
The study will assess the safety of the vaccinations and the immune responses to the vaccination Immune responses are measured by tests on blood samples
Healthy volunteers will be recruited in Oxford and Southampton England
All vaccines will be administered intramuscularly
Group 1 will receive one dose of ChAd63 Pfs25-IMX313 at 5x109 vp
Group 2A will receive one dose of ChAd63 Pfs-IMX313 at 5x1010 vp
Group 2B will receive one dose of ChAd63 Pfs-IMX313 at 5x1010 vp and one dose of MVA Pfs25-IMX313 at 1x108 pfu eight weeks later
Group 2C will receive one dose of ChAd63 Pfs25-IMX313 at 5x1010 vp and one dose of MVA Pfs25-IMX313 at 2x108 pfu eight weeks later
The study will assess the safety of the vaccinations and the immune responses to the vaccination Immune responses are measured by tests on blood samples
Healthy volunteers will be recruited in Oxford and Southampton England
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None