Skip to main content
. 2006 Oct 18;2006(4):CD006198. doi: 10.1002/14651858.CD006198

Brown 1994.

Methods Randomized controlled trial
Generation of allocation sequence: not stated
Allocation concealment: coded vials of similar appearance for vaccine and control; prepared externally by the Swiss Serum and Vaccine Institute and provided to the investigators
Blinding: double blind
Inclusion of all randomized participants: 84% completed the study
Length of follow up: 4 months after last dose
Participants Number: 199 male Thai soldiers; malaria‐naive (44) or malaria‐experienced (155)
Inclusion criteria: age 18 to 45 years
Exclusion criteria: significant cardiac, hepatic, renal, or immunological disease; recent surgery; human immunodeficiency virus (HIV) antibody positivity; use of immunosuppressive drugs; anaemia (haemoglobin < 10 g/dL); diabetes; history of significant allergy
Interventions 1. R32Tox‐A vaccine: 3 doses (320 µg per 0.4 mL dose, adsorbed onto aluminium hydroxide) at 8 and 16 weeks
 2. Tetanus/diphtheria toxoids: 10 and 1 Lf units, respectively, in first dose and phosphate buffered saline in subsequent doses
Outcomes 1. Malaria cases (case definition: positive slide)
 2. Time to malaria diagnosis
 3. Polymerase chain reaction (PCR)‐detected CS sequences from cases
 4. Anti‐R32LR IgG and IgM levels
 5. Anti‐toxin A antibody
 6. Adverse events
Notes Location: Ubon Ratchatani Province on Thai‐Cambodian border
Participants were vaccinated in a non‐endemic area and then deployed in camps in endemic areas
Method of surveillance: bi‐weekly active and passive case detection