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Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania

NCT00513669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-03-15

No results posted yet for this study

Summary

This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children.

Conditions

  • Falciparum Malaria

Interventions

BIOLOGICAL

PEV 301& 302 in virosomes

PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90

BIOLOGICAL

Inflexal V (active comparator)

Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90

Sponsors & Collaborators

  • Mymetics Corporation

    collaborator INDUSTRY

  • Pevion Biotech Ltd

    collaborator INDUSTRY

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Blaise Genton, MD PhD · Swiss tropical institute, Ifakara Health Research and Development Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00513669 on ClinicalTrials.gov