Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374998
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2006-09-10
Brief Title:
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
Sponsor:
European Vaccine Initiative
Organization:
European Vaccine Initiative
Study Overview
Official Title:
A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule
Status:
COMPLETED
Status Verified Date:
2007-02
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 study examines two new malaria vaccines FP9-PP and MVA-PP in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria
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 two candidate malaria vaccines FP9-PP and MVA-PP in different concentrations and combinations These live viral vectors encode a polyprotein of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle MVA-PP uses the Modified Virus Ankara vector a weakened form of the smallpox vaccine vaccinia FP9-PP uses a highly attenuated avian pox virus FP9 as the vector instead The two vaccines will be used in combination in a prime boost strategy to enhance the response of the cellular immune system
This study will
1 Examine safety
2 Examine immunogenicity
3 Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study VAC0272
The purpose of this study is to test two candidate malaria vaccines FP9-PP and MVA-PP in different concentrations and combinations These live viral vectors encode a polyprotein of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle MVA-PP uses the Modified Virus Ankara vector a weakened form of the smallpox vaccine vaccinia FP9-PP uses a highly attenuated avian pox virus FP9 as the vector instead The two vaccines will be used in combination in a prime boost strategy to enhance the response of the cellular immune system
This study will
1 Examine safety
2 Examine immunogenicity
3 Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study VAC0272
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 |
|---|---|---|---|
| EudraCT number 2004-002424-17 | None | None | None |
| EMVI trial identifier PP_1_04 | None | None | None |