Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers

Conditions
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Falciparum Malaria

Intervention / Treatment
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* Biological: Virosome-formulated synthetic peptides (malaria vaccine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Virosome-formulated synthetic peptides (malaria vaccine)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  |  | 
| Antibody concentration by Elisa |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody concentration by IFAT and Western blot |  |  | 
| Cellular immunity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Vaccine, Plasmodium, falciparum, Phase I, Peptide, Virosome, safety, immunogenicity