Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
Information source: Swiss Tropical & Public Health Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Falciparum Malaria
Intervention: Virosome-formulated synthetic peptides (malaria vaccine) (Biological)
Phase: Phase 1
Status: Terminated
Sponsored by: Swiss Tropical & Public Health Institute Official(s) and/or principal investigator(s): Blaise Genton, MD PhD, Principal Investigator, Affiliation: Swiss Tropical & Public Health Institute
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.
Clinical Details
Official title: A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
Primary outcome: Incidence of adverse eventsAntibody concentration by Elisa
Secondary outcome: Antibody concentration by IFAT and Western blotCellular immunity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy volunteers of both sexes, aged between 18 and 45 years, with a BMI > 18. 5 and
<30 were included if they gave written informed consent
Exclusion Criteria:
- Chronix or acute illness, immunosuppression, lived in the past in a malaria endemic
area, had visited such an area in the last 12 months, or had a history of clinical
malaria
Locations and Contacts
Additional Information
Starting date: November 2003
Last updated: November 15, 2006
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