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GMZ2-Aluminum Hydroxide Phase I, Tübingen

NCT00397449 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-08-10

No results posted yet for this study

Summary

This is a randomized, open, dose-selection Phase 1 study. The study aims to evaluate the safety and immunogenicity of 3 doses (10,30 \& 100 micrograms) of the GMZ2 hybrid (GLURP and MSP3) blood stage vaccine in healthy non-immune European adults. The vaccines will be administered with aluminum hydroxide as adjuvant. The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions related to the vaccine. The safety profile will include local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria. The immunogenicity of the different formulation of the vaccine will be assessed on the level and the quality of circulating antibodies as well as the stimulation of the T-cell immune response.

Conditions

Interventions

BIOLOGICAL

GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)

Sponsors & Collaborators

  • European Vaccine Initiative

    lead OTHER

Principal Investigators

  • Jurgen Knobloch, MD · Insitut of Tropical Medicine, University of Tubingen

  • Peter Kremsner, MD, PhD · Insitut of Tropical Medicine, University of Tubingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Completion
2007-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00397449 on ClinicalTrials.gov