None listed
Conditions
Brief summary
The goal of this Phase 1 vaccine trial is to demonstrate safety and immunogenicity of MSP2-C1/ISA720 malaria vaccine in healthy adult human volunteers. The World Health Organisation reported in 2005 that malaria kills more than 1 million people annually and that approximately 3.2 million people living in 107 countries or territories are at risk of infection [1]. Most of the malaria mortality occurs in sub Saharan Africa and in children under 5 years of age. Of the four species of malaria parasite that infect humans, Plasmodium falciparum is responsible for the majority of these deaths. Mounting drug resistance of the malaria parasite, as well as widespread resistance of mosquitoes to insecticides, make these control strategies increasingly unrealistic. A vaccine that would reduce both mortality and morbidity secondary to P. falciparum infection would be a valuable resource in the fight against this disease.
Interventions
The MSP2-C1/ ISA720 malaria vaccine is supplied as a milky white emulsion in single dose vials. Each 5 mL vial contains 0.8 mL, of which 0.5 mL is the intended volume to be injected. 0.5 mL of vaccine contains the equivalent of 0.15 ml of buffer containing antigen emulsified in Montanide® ISA720. The MSP2-C1/ ISA720 vaccine and ISA720 Control conforms to established requirements for sterility, safety and identity. The MSP2-C1/ISA720 malaria vaccine will be injected intramascularly into the 3
The MSP2-C1/ ISA720 malaria vaccine is supplied as a milky white emulsion in single dose vials. Each 5 mL vial contains 0.8 mL, of which 0.5 mL is the intended volume to be injected. 0.5 mL of vaccine contains the equivalent of 0.15 ml of buffer containing antigen emulsified in Montanide® ISA720. The MSP2-C1/ ISA720 vaccine and ISA720 Control conforms to established requirements for sterility, safety and identity. The MSP2-C1/ISA720 malaria vaccine will be injected intramascularly into the 3 subgroups of participants within the intervention group. The vaccine will be provided in multiple doses, as three immunizations, twelve weeks apart. The first subgroup will receive 10 micrograms in each injection, the second subgroup will receive 40 micrograms in each injection, and the third subgroup will receive 80 micrograms in each injection.
Sponsors
The Queensland Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, withhold donating blood.
Exclusion criteria
Malaria disease or exposure, intercurrent disease, recent illness, treatment with corticosteroids, anti-coagulant, anti-inflammatory or immunomodulator drugs, history severe allergic reaction or anaphylaxis, live vaccination within 4 weeks or dead vaccination within 2 weeks or participation in a clinical trial in the 4 weeks prior
Outcome results
None listed