NCT00400101

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2003

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
Last Updated

November 16, 2006

Status Verified

November 1, 2006

First QC Date

November 15, 2006

Last Update Submit

November 15, 2006

Conditions

Falciparum Malaria

Keywords

MalariaVaccinePlasmodiumfalciparumPhase IPeptideVirosomesafetyimmunogenicity

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

  • Antibody concentration by Elisa

Secondary Outcomes (2)

  • Antibody concentration by IFAT and Western blot

  • Cellular immunity

Interventions

Virosome-formulated synthetic peptides (malaria vaccine)BIOLOGICAL

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1371/journal.pone.0001278.

    PMID: 18060072DERIVED

  • 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. doi: 10.1371/journal.pone.0001018.

    PMID: 17925866DERIVED

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

Malaria Vaccines

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Protozoan VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Blaise Genton, MD PhD

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

November 1, 2003

Study Completion

October 1, 2005

Last Updated

November 16, 2006

Record last verified: 2006-11