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Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers

NCT00730782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2008-08-08

No results posted yet for this study

Summary

The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

PfAMA-1-FVO[25-545]

Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Biomedical Primate Research Centre

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Seppic

    collaborator INDUSTRY

  • European Vaccine Initiative

    lead OTHER

Principal Investigators

  • Robert Sauerwein, Prof. MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-09-30
Completion
2008-08-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT00730782 on ClinicalTrials.gov