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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 events

Antibody concentration by Elisa

Secondary outcome:

Antibody concentration by IFAT and Western blot

Cellular 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

Page last updated: August 23, 2015

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