Sporozoite Challenge of Polyprotein Vaccinees
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 VAC027.1.
Biological: FP9-PP (FP9 polyprotein)
Biological: MVA-PP (Modified Virus Ankara polyprotein)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Efficacy (time in hours to parasitaemia)
|Study Start Date:||September 2006|
|Study Completion Date:||April 2007|
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 VAC027.1.
Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P. falciparum malaria.
This trial will:
- Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
- Examine immunogenicity before and after malaria infection
- Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375128
|Imperial College, University of London|
|London, United Kingdom, SW7 2AZ|
|Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford|
|Oxford, United Kingdom, OX3 7LJ|
|Principal Investigator:||Adrian VS Hill, MA, BM BCh, DPhil, DM||University of Oxford|