Genton 2000.
Methods | Randomized controlled trial Generation of allocation sequence: computer‐generated list Allocation concealment: unclear Blinding: participants blinded Inclusion of all randomized participants: 100% completed trial Length of follow up: 6 weeks after second dose |
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Participants | Number: 12 adults Inclusion criteria: age 18 to 50 years Exclusion criteria: allergic predisposition; acute illness on day of screening; chronic illness; impaired liver or kidney function; human immunodeficiency virus (HIV) infection |
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Interventions | 1. MSP1/MSP2/RESA vaccine in adjuvant Montanide ISA720: 2 doses at 4‐week intervals; 0.55 mL per dose containing 15 µg of each antigen
2. Adjuvant only: 0.55 mL All participants given sulfadoxine‐pyrimethamine before first dose to clear parasites |
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Outcomes | 1. Adverse events (local or systemic) 2. Immunologic outcomes | |
Notes | Location: Goroka and Wosera, Papua New Guinea; participants were moved to Goroka (non‐endemic area) during immunization Method of surveillance: observation by physician for 6 h after immunization, daily visits for 2 weeks; weekly observation for 6 weeks |