Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400101
Status:
TERMINATED
Last Update Posted:
2006-11-16
First Post:
2006-11-15
Brief Title:
Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
Sponsor:
Swiss Tropical Public Health Institute
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers
Status:
TERMINATED
Status Verified Date:
2006-11
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:
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 derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans
Detailed Description:
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
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 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