Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375128
Status:
COMPLETED
Last Update Posted:
2007-10-19
First Post:
2006-09-10
Brief Title:
Sporozoite Challenge of Polyprotein Vaccinees
Sponsor:
European Vaccine Initiative
Organization:
European Vaccine Initiative
Study Overview
Official Title:
Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Polyprotein Malaria Vaccines FP9-PP MVA-PP and Control Non-Vaccinated Volunteers
Status:
COMPLETED
Status Verified Date:
2007-10
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:
This study examines the ability of two new malaria vaccines FP9-PP and MVA-PP to prevent the development of malaria infection after controlled exposure to the parasite Volunteers for this trial will have received these vaccines in the preceding trial VAC0271
Detailed Description:
Malaria infection kills over 2 million people each year It is a major problem for those who live in endemic areas and for travellers There is clearly a great need for a safe effective malaria vaccine
The purpose of this study is to test the clinical efficacy of two candidate malaria vaccines FP9-PP and MVA-PP These live viral vector vaccines were administered in a prime boost regime in the preceding trial VAC0271
Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P falciparum malaria
This trial will
1 Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
2 Examine immunogenicity before and after malaria infection
3 Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later
The purpose of this study is to test the clinical efficacy of two candidate malaria vaccines FP9-PP and MVA-PP These live viral vector vaccines were administered in a prime boost regime in the preceding trial VAC0271
Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P falciparum malaria
This trial will
1 Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
2 Examine immunogenicity before and after malaria infection
3 Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later
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 |
|---|---|---|---|
| EMVI trial identifier PP_2_04 | None | None | None |
| EudraCT number 2006-000629-67 | None | None | None |