title: An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial.
abstract: Ross River virus (RRV) is endemic in Australia and several South Pacific Islands. More than 90,000 cases of RRV disease, which is characterized by debilitating polyarthritis, were reported in Australia in the last 20 years. There is no vaccine available to prevent RRV disease. A phase 3 study was undertaken at 17 sites in Australia to investigate the safety and immunogenicity of an inactivated whole-virus Vero cell culture-derived RRV vaccine in 1,755 healthy younger adults aged 16 to 59 years and 209 healthy older adults aged ≥60 years. Participants received a 2.5-μg dose of Al(OH)(3)-adjuvanted RRV vaccine, with a second and third dose after 3 weeks and 6 months, respectively. Vaccine-induced RRV-specific neutralizing and total IgG antibody titers were measured after each immunization. Vaccine safety was monitored over the entire study period. The vaccine was safe and well-tolerated after each vaccination. No cases of arthritis resembling RRV disease were reported. The most frequently reported systemic reactions were headache, fatigue, and malaise; the most frequently reported injection site reactions were tenderness and pain. After the third immunization, 91.5% of the younger age group and 76.0% of the older age group achieved neutralizing antibody titers of ≥1:10; 89.1% of the younger age group and 70.9% of the older age group achieved enzyme-linked immunosorbent assay (ELISA) titers of ≥11 PanBio units. A whole-virus Vero cell culture-derived RRV vaccine is well tolerated in an adult population and induces antibody titers associated with protection from RRV disease in the majority of individuals. (This study is registered at www.clinicaltrials.gov under registration no. NCT01242670.).
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria nina_wressnigg@baxter.com.
authors.forename: Nina
authors.initials: N
authors.lastname: Wressnigg
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Maikel V W
authors.initials: MV
authors.lastname: van der Velden
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Portsmouth
authors.affiliation: Global R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Draxler
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: Maria
authors.initials: M
authors.lastname: O'Rourke
authors.affiliation: University of Western Australia School of Paediatrics and Child Health and Vaccine Trials Group, Subiaco, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Richmond
authors.affiliation: Emeritus Research, Monash University, Victoria, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hall
authors.affiliation: James Cook University, School of Medicine and Dentistry, Cairns, Australia.
authors.forename: William J H
authors.initials: WJ
authors.lastname: McBride
authors.affiliation: Linear Clinical Research Ltd., QEII Medical Centre, Nedlands, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Redfern
authors.affiliation: Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia Australian Army Malaria Institute, Brisbane, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Aaskov
authors.affiliation: Vaccine R&D, Baxter BioScience, Orth/Donau, Austria.
authors.forename: P Noel
authors.initials: PN
authors.lastname: Barrett
authors.affiliation: Vaccine R&D, Baxter BioScience, Vienna, Austria.
authors.forename: Gerald
authors.initials: G
authors.lastname: Aichinger
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018354:Alphavirus Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral; D001315:Australia / Q000453:epidemiology; D002522:Chlorocebus aethiops; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D012398:Ross River virus / Q000276:immunology*; D014611:Vaccination; D015164:Vaccines, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014709:Vero Cells; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D015164:Vaccines, Inactivated; D014765:Viral Vaccines