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
Sponsor study identifier
Secondary identifiers
interventional
30
1 country
1
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 5, 2006
Actual (reported)December 7, 2006
Actual (reported)Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.
Immunogenicity - Vaccine immunogenicity assessed by IFN-γ ELISPOT and ELISA for vaccine specific antibodies
Safety - Vaccine safety assessed by collection of local and systemic adverse events.
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Thompson FM, Porter DW, Okitsu SL, Westerfeld N, Vogel D, Todryk S, Poulton I, Correa S, Hutchings C, Berthoud T, Dunachie S, Andrews L, Williams JL, Sinden R, Gilbert SC, Pluschke G, Zurbriggen R, Hill AV. Evidence of blood stage efficacy with a virosomal malaria vaccine in a phase IIa clinical trial. PLoS One. 2008 Jan 30;3(1):e1493. doi: 10.1371/journal.pone.0001493.
Adrian VS Hill, MA, BM BCh, DPhil, DM
University of Oxford
First Submitted
December 5, 2006
First Posted
December 7, 2006
Study Start
August 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
February 2006
Date type not reportedSafety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
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This date has not been verified as actual or estimated.
Last Updated
December 7, 2006
Record last verified: 2006-10
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Source: ClinicalTrials.gov.
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