Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408668
Status:
COMPLETED
Last Update Posted:
2006-12-07
First Post:
2006-12-05
Brief Title:
Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Virosomal Vaccine PEV3A and FP9-MVA ME-TRAP A Phase I IIa Controlled Challenge Trial
Status:
COMPLETED
Status Verified Date:
2006-10
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:
The purpose of this study is to test three candidate malaria vaccines in new combinations to assess their efficacy at preventing malaria infection and triggering immune responses against malaria
Detailed Description:
Two of the vaccines FP9 ME-TRAP and MVA ME-TRAP have been designed at the University of Oxford The other vaccine PEV3A has been designed jointly between the Swiss Tropical Institute and a Swiss company called Pevion Biotech Ltd These are new vaccines that have been given to only a limited number of people before
We aim to test these vaccines by
assessing their ability to prevent malaria infection
determining how good they are at triggering a detectable immune response against malaria
studying their safety further
Volunteers will be given up to six vaccinations over three months and will then be exposed to malaria infection We do this by allowing mosquitoes infected with malaria to bite them under closely regulated conditions and observing if and when they develop blood stage malaria If the vaccines provide some protection from malaria infection then either they will not develop malaria after the bites or the time taken to develop malaria will be longer If not all volunteers are protected then we will be able to try and improve our vaccines by comparing the immune responses of volunteers who are protected to those not protected
The information we get from this study may help to prevent malaria infection and disease in those who live in endemic areas and in travellers The results of this study will be published in scientific journals and may be presented at professional meetings
We aim to test these vaccines by
assessing their ability to prevent malaria infection
determining how good they are at triggering a detectable immune response against malaria
studying their safety further
Volunteers will be given up to six vaccinations over three months and will then be exposed to malaria infection We do this by allowing mosquitoes infected with malaria to bite them under closely regulated conditions and observing if and when they develop blood stage malaria If the vaccines provide some protection from malaria infection then either they will not develop malaria after the bites or the time taken to develop malaria will be longer If not all volunteers are protected then we will be able to try and improve our vaccines by comparing the immune responses of volunteers who are protected to those not protected
The information we get from this study may help to prevent malaria infection and disease in those who live in endemic areas and in travellers The results of this study will be published in scientific journals and may be presented at professional meetings
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MRC agreement ID 74636 | None | None | None |