Aaskov, John G.

Aichinger, Gerald

Ehrlich, Hartmut J.

et al.

Hens, Annick

van Damme, Pierre

Abstract: Background Ross River virus (RRV) is endemic in Australia and several South Pacific Islands. Approximately 5000 cases of RRV disease, which is characterized by debilitating polyarthritis, are recorded each year in Australia. This study describes the first clinical trial of a candidate RRV vaccine. Methods An inactivated whole-virus Vero cell-derived RRV vaccine was tested in 382 healthy, RRV-na\uefve adults in a phase 1/2 dose-escalation study at ten sites in Austria, Belgium and The Netherlands. Subjects were equally randomized to receive 1.25 \u3bcg, 2.5 \u3bcg, 5 \u3bcg, or 10 \u3bcg aluminum hydroxide-adjuvanted or non-adjuvanted RRV vaccine, with a second dose after three weeks and a booster at six months. Vaccine immunogenicity was determined by measurements of serum IgG and neutralizing antibody titers. Vaccine tolerability and safety were monitored over the entire study period. Results The optimal vaccine formulation was the adjuvanted 2.5 \u3bcg dose, as calculated using a repeated mixed model analysis of covariance comparing log-transformed RRV-specific IgG titers between different dose groups. Geometric means of RRV-specific serum antibodies measured 21 days after the third vaccination with the 2.5 \u3bcg adjuvanted formulation were 520.9 (90% CI 377.2719.4) as determined by IgG ELISA and 119.9 (82.6173.9) as determined by virus neutralization assay, resulting in seropositivity rates of 92.9% (82.698.0) and 92.7% (82.298.0), respectively. All vaccine formulations and doses were well tolerated after the first, second and third vaccination. Conclusions The adjuvanted, inactivated whole-virus Vero cell-derived Ross River virus vaccine is highly immunogenic in RRV-na\uefve adults and well tolerated at all dose levels

Safety and immunogenicity of an inactivated whole virus Vero cell-derived Ross River virus vaccine : a randomized trial

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