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. 2006 Oct 18;2006(4):CD006199. doi: 10.1002/14651858.CD006199

Saul 1999a.

Methods Randomized controlled trial
Generation of allocation sequence: computer‐generated randomization; participants were randomly divided in 3 groups that were vaccinated sequentially, but screening and scheduling arrangements led to some reassignment between groups; 2 in each group were randomly chosen to receive placebo
Allocation concealment: unclear
Blinding: participants blinded; immunological assessors also blinded
Inclusion of all randomized participants: 100% completed trial, although 1 participant in placebo group was inadvertently given vaccine instead
Length of follow up: 12 months for immunologic outcomes; unclear for adverse events
Participants Number: 32 adults
Inclusion criteria: medical or veterinary student at University of Queensland
Exclusion criteria: history of malaria; visit to malaria endemic region in last 12 months; acute illness or immunization with live vaccine in last 4 weeks; markers of current hepatitis B or HIV infection; current medication with corticosteroids, anti‐inflammatory drugs, or anticoagulants; current smoking > 10/day; pregnancy; elevated antinuclear antibodies
Interventions 1. Mixture of 3 antigens (MSP1, MSP2, RESA) plus adjuvant: 2 doses; each 1.8 mL in 1 site 
 2. Placebo (adjuvant in saline): 2 doses; each 1.8 mL in 1 site
 3. MSP1, MSP2, RESA plus adjuvant: 2 doses in separate sites; each 0.6 mL
 4. Placebo (adjuvant in saline): 2 doses in separate sites; each 0.6 mL
The planned dose schedule was 2 doses at 4‐week intervals with 100 µg each antigen each dose, but adverse reactions in first two‐thirds of vaccinees resulted in drop to 50 µg of antigen at first dose for the remaining one third of participants and a delay between doses of approximately 6 weeks. The second dose was 20 µg each antigen in 0.36 mL at single site or 0.12 mL at each of 3 separate sites
Outcomes 1. Adverse events, classified as mild, moderate, or severe
 2. Immunological outcomes
Notes Location: Brisbane, Australia
This trial reported in same publication as Saul 1999b