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 |
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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 |
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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 |