Sporozoite Challenge of Polyprotein Vaccinees
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00375128|
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : October 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum Malaria||Biological: FP9-PP (FP9 polyprotein) Biological: MVA-PP (Modified Virus Ankara polyprotein)||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2006|
|Actual Study Completion Date :||April 2007|
- Efficacy (time in hours to parasitaemia)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|