Wright 2008.
| Methods |
Design: double‐blind randomized placebo controlled study conducted in two phases (Phase 1:a first dose of vaccine or placebo administered to participants; Phase 2: a second dose of vaccine or placebo admnistered to participants) Length of follow up: 180 days for Phase 1 and Phase 2 studies |
| Participants | Number: 28 healthy adult volunteers |
| Interventions |
Vaccine: live‐attenuated Langat/dengue 4 chimeric virus vaccine Placebo: vaccine diluent Schedule: 2 x 0.5 mL/dose (Phase 1: first dose; Phase 2: second dose) subcutaneously in the deltoid region |
| Outcomes | 1. Seroconversion defined as a serum neutralizing antibody titer of at least 1:20 compared with prevaccination titre < 1:5 2. Geometric mean titre 3. LGT/DEN4 virus infection; vaccine related meningoencephalitic‐like syndrome 4. Local reactogenicity 5. Headache, rash, fever, neutropenia, elevated ALT level 5. Serious adverse events (hospitalization, congenital anomaly or birth defect, disability, death) |
| Notes | Location: Nashville area (USA) |