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.
Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the Merozoite Surface Protein 3 (MSP 3).This product has been developed at State Serum Institute/EMVI in Denmark and Batch released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers was done in Germany, at Tuebingen University. This phase Ia trial established safety of the vaccine and also assisted in selecting the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be tested for the phase Ib trials in Gabon, including this phase Ib trial in children. Objectives: Primary objective: To evaluate the safety and reactogenicity of three doses of 30 and 100µg GMZ2, adsorbed on aluminium hydroxide, in comparison with three doses of the control vaccine (rabies), in healthy Gabonese children aged 1-5 years. Secondary objectives: To assess the humoral immune response to the vaccine antigens GMZ2, GLURP and MSP3 by measuring the total IgG concentration and IgG isotypes against GMZ2 by ELISA. To assess B-cell memory by memory B-cell ELISPOT. Exploratory Objectives: To assess the functionality of the immune response by measuring the Growth Inhibition of P. falciparum in the presence or absence of Monocytes, and by measuring the recognition of native antigen of P. falciparum by IFA. Study Design: Phase Ib double-blind, randomised, and controlled trial with three groups at one study site; rabies vaccine,30µg and 100 µg GMZ 2 vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
30
three doses of 30µg of GMZ 2 vaccine,
100 µg of GMZ 2 vaccine
3 doses of Rabies vaccine
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, Gabon
Immediate reactogenicity.
Time frame: within 30 minutes after each injection
Local and systemic reactogenicity
Time frame: 14 days following each immunization
unsolicited Adverse events
Time frame: up to 1 month after the 3rd vaccination
Occurrence of serious adverse events
Time frame: 1 year
Biological safety
Time frame: 1 year
Humoral immune response to GLURP and MSP 3
Time frame: 1 year
Cellular immune response
Time frame: 1 year
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