A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years
The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety. This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.
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
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.