The primary and secondary objectives of this Phase 1 study are respectively to assess the safety and the immunogenicity of two administrations of the RSV vaccine candidate at three different doses. The study has a randomized, placebo-controlled, double-blind, sequential, parallel cohorts, dose-escalation (three dosages) design. Each of the three cohorts (N=20 subjects per cohort, total of 60 subjects) will receive placebo (n=5), or a low (15 µg, n=15), intermediate (50 µg, n=15) or high dosage (150 µg, n=15) of candidate vaccine, on two occasions (Day 0 and Day 56). Subjects will be healthy adult women aged between 18 and 45 years. There will be two phases: an active treatment phase from Day 0 to Month 3, and a follow-up phase from Month 3 + 1 day to Month 12. During the active phase, subjects will complete diary cards to record oral temperature (daily), solicited local and general adverse events (AEs) and unsolicited AEs for 7 days after each administration. Unsolicited AEs will be recorded up to Day 28 post-each administration. Serious adverse events (SAEs) and adverse events of specific interest (AESI) will be recorded throughout the duration of the active phase. Subjects will visit the clinical site for safety monitoring on Days 1, 7 and 28 following each administration. Blood will be drawn at a screening visit and the safety test data will be available just before 1st administration. The screening set includes markers of infection with hepatitis B virus, hepatitis C virus and human immunodeficiency virus. A serum sample will be taken for detection of pregnancy. At the next scheduled time points, pregnancy will be screened in a urine sample. Laboratory safety parameters will be examined further at Days 0, 1, 7, 28, 56, 57, 63 and 84. During the follow-up phase, visits for safety monitoring are scheduled at Months 6, 9 and 12 post-1st administration. SAEs and AESI will be recorded at each visit. Humoral immunity will be measured on Days 0, 28, 56, Month 3, Month 6, Month 9 and Month 12. Cellular immunity will be measured on Days 0, 7, 28, 56, 63 and 84. The duration of the study for each subject will be approximately 13 months. The total duration of the study will be approximately 18 months.
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Solicited local and general adverse events
Timeframe: During 7 days post-each administration
Adverse events of special interest (AESI)
Timeframe: Day 0 to Month 12
Serious adverse events
Timeframe: Day 0 to Month 12