Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides - Full Text View

Sponsor:	Swiss Tropical & Public Health Institute
Information provided by:	Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:	NCT00400101

Purpose

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.

Condition	Intervention	Phase
Falciparum Malaria	Biological: Virosome-formulated synthetic peptides (malaria vaccine)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Official Title:	A Randomized Placebo-Controlled Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Synthetic Peptides in Healthy Adult Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Malaria

U.S. FDA Resources

Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:

Incidence of adverse events
Antibody concentration by Elisa

Secondary Outcome Measures:

Antibody concentration by IFAT and Western blot
Cellular immunity

Estimated Enrollment:	46
Study Start Date:	November 2003
Estimated Study Completion Date:	October 2005

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

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400101

Sponsors and Collaborators

Swiss Tropical & Public Health Institute

Investigators

Principal Investigator:

Blaise Genton, MD PhD

Swiss Tropical & Public Health Institute

More Information

No publications provided by Swiss Tropical & Public Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Okitsu SL, Silvie O, Westerfeld N, Curcic M, Kammer AR, Mueller MS, Sauerwein RW, Robinson JA, Genton B, Mazier D, Zurbriggen R, Pluschke G. A virosomal malaria peptide vaccine elicits a long-lasting sporozoite-inhibitory antibody response in a phase 1a clinical trial. PLoS ONE. 2007 Dec 5;2(12):e1278.

Genton B, Pluschke G, Degen L, Kammer AR, Westerfeld N, Okitsu SL, Schroller S, Vounatsou P, Mueller MM, Tanner M, Zurbriggen R. A randomized placebo-controlled phase Ia malaria vaccine trial of two virosome-formulated synthetic peptides in healthy adult volunteers. PLoS ONE. 2007 Oct 10;2(10):e1018.

ClinicalTrials.gov Identifier:	NCT00400101 History of Changes
Other Study ID Numbers:	PEV001
Study First Received:	November 15, 2006
Last Updated:	November 15, 2006
Health Authority:	Switzerland: Swissmedic

Keywords provided by Swiss Tropical & Public Health Institute:

Malaria
Vaccine
Plasmodium
falciparum
Phase I

Peptide
Virosome
safety
immunogenicity

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on May 22, 2012