Outcomes
VIRUS, ADVERSE EVENTS, RVF, SECONDARY, APPENDIX
The primary objective of the study was assessment of safety and tolerability of the vaccine in a healthy adult population. Primary outcome measures were: occurrence of local and systemic solicited adverse events for 7 days after vaccination, occurrence of unsolicited adverse events for 28 days after vaccination, changes in clinical laboratory measures from baseline to day 28, and occurrence of serious adverse events (SAEs) throughout the trial period. The secondary objective was humoral and cellular immunogenicity of the vaccine. Secondary outcome measures were: RVF nAb titres measured against live RVF virus, IgG binding antibody titres measured by enzyme-linked immunosorbent assay (ELISA) against recombinant Gn and Gc proteins, and cellular responses to overlapping peptides spanning the Gn-Gc polyprotein measured by ex-vivo interferon-γ (IFNγ) enzyme-linked immunospot (ELISpot) assay. Exploratory outcomes measures were: IgG1-4 subclass antibody ELISA titres against Gn and Gc proteins, and analysis of correlations between immune parameters. Full details of the immunological assay procedures are in the Supplementary Appendix.