NCT00397449

GMZ2-Aluminum Hydroxide Phase I, Tübingen

Assessment of the Safety and Immunogenicity of the Recombinant Lactococcus Lactis Hybrid GMZ2 [GLURP+MSP3] a Malaria Vaccine in Healthy Adult Volunteers. A Phase I, Double-Blind, Randomised, Dose-Selection, Unicentre Trial

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: European Vaccine Initiative · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The trial is a randomised, open, dose-selection, single centre trial. One adjuvant will be assessed, aluminum hydroxide (alum). Three different dosages - 10µg, 30µg, and 100µg - of GMZ2 will be evaluated with the aluminum hydroxide adjuvant. A total of 30 volunteers will be enrolled and randomized into three groups of 10. As this is a dose escalation study, volunteers in Group 1 will receive the initial dose of 10µg on the first vaccination day. After a satisfactory safety profile at this dose (see sections 6.2.2 and 6.2.3), we will proceed to vaccinate volunteers in Group 2 with the higher dose of 30µg after a 2-week interval. The same procedure will also be followed for volunteers in Group 3, who will be administered their initial dose of 100µg GMZ2 if the review of the safety profile of Group 2 is satisfactory. The aim will be to recruit all volunteers before the intended start of the study. The randomization procedure will be performed in the following way: when participants are found to be eligible and have signed their informed consent they will be numbered sequentially (in order of enrollment). The numbers will be randomly assigned to 3 groups of 10 numbers through a specific randomization computer program. These groups will be the treatment groups.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	GMZ2 (GLURP + MSP3 Hybrid) (malaria vaccine)

Timeline

• Start date: 2006-10-01
• Completion: 2007-12-01
• First posted: 2006-11-09
• Last updated: 2007-08-10

Locations

1 site across 1 country: Germany