viral infections
Conditions
Brief summary
The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 1 and day 8 after revaccination
Detailed description
Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination., Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D8 and D15 after the simulated post-exposure vaccination, Percentage of subjects with RVNA titer >3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP., GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination
Interventions
Sponsors
Academisch Ziekenhuis Leiden
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the rate of increase of geometric mean concentrations (GMC) of neutralizing antibodies between day 1 and day 8 after revaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination., Percentage of subjects with RVNA titer >0.5 IU/mL at D1, D8 and D15 after the simulated post-exposure vaccination, Percentage of subjects with RVNA titer >3 IU/mL, and percentage of subjects with RVNA titers >5 IU/mL at day 8 after simulated PEP., GMCs at D1, D57 or D64, Y1, Y2 and Y5 after primary vaccination, and at D1, D8 and D15 after the simulated post-exposure vaccination | — |
Countries
Netherlands
Outcome results
None listed