Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
|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: NCT00400101|
Recruitment Status : Terminated
First Posted : November 16, 2006
Last Update Posted : November 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Falciparum Malaria||Biological: Virosome-formulated synthetic peptides (malaria vaccine)||Phase 1|
Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides. The specific objective was to demonstrate the safety and immunogenicity of two virosome-formulated P. falciparum protein derived synthetic peptide antigens given in two different doses alone or in combination.
Methodology The design was a single blind, randomized, placebo controlled, dose-escalating study involving 46 healthy Caucasian volunteers aged 18-45 years. Five groups of 8 subjects received virosomal formulations containing 10 ug or 50 ug of AMA 49-CPE, an apical membrane antigen-1 (AMA-1) derived synthetic phospatidylethanolamine (PE)-peptide conjugate or 10 ug or 50 ug of UK39, a circumsporozoite protein (CSP) derived synthetic PE-peptide conjugate or 50 ug of both antigens each. A control group of 6 subjects received unmodified virosomes. Virosomal formulations of the antigens (designated PEV301 and PEV302 for the AMA-1 and the CSP virosomal vaccine, respectively) or unmodified virosomes were injected i. m. on days 0, 60 and 180.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers|
|Study Start Date :||November 2003|
|Study Completion Date :||October 2005|
- Incidence of adverse events
- Antibody concentration by Elisa
- Antibody concentration by IFAT and Western blot
- Cellular immunity
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): NCT00400101
|Principal Investigator:||Blaise Genton, MD PhD||Swiss Tropical & Public Health Institute|