GMZ2-Aluminum Hydroxide Phase I, Tübingen

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.

Timeline

Start

2006-10

Primary completion

—

Completion

2007-12

Drugs

Indications