An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial

Nina Wressnigg, Maikel V W van der Velden, Daniel Portsmouth, Wolfgang Draxler, Maria O'Rourke, Peter Richmond, Stephen Hall, William John McBride, Andrew D Redfern, John Aaskov, P Noel Barrett, Gerald Aichinger

Research output: Contribution to journalArticleResearchpeer-review

15 Citations (Scopus)

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- g 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 welltolerated 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.)
Original languageEnglish
Pages (from-to)267 - 273
Number of pages7
JournalClinical and Vaccine Immunology
Volume22
Issue number3
DOIs
Publication statusPublished - 2015

Cite this

Wressnigg, N., van der Velden, M. V. W., Portsmouth, D., Draxler, W., O'Rourke, M., Richmond, P., ... Aichinger, G. (2015). An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial. Clinical and Vaccine Immunology, 22(3), 267 - 273. https://doi.org/10.1128/CVI.00546-14
Wressnigg, Nina ; van der Velden, Maikel V W ; Portsmouth, Daniel ; Draxler, Wolfgang ; O'Rourke, Maria ; Richmond, Peter ; Hall, Stephen ; McBride, William John ; Redfern, Andrew D ; Aaskov, John ; Barrett, P Noel ; Aichinger, Gerald. / An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial. In: Clinical and Vaccine Immunology. 2015 ; Vol. 22, No. 3. pp. 267 - 273.
@article{133a88c1912b42b5bbd905ea71672b16,
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- g 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 welltolerated 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.)",
author = "Nina Wressnigg and {van der Velden}, {Maikel V W} and Daniel Portsmouth and Wolfgang Draxler and Maria O'Rourke and Peter Richmond and Stephen Hall and McBride, {William John} and Redfern, {Andrew D} and John Aaskov and Barrett, {P Noel} and Gerald Aichinger",
year = "2015",
doi = "10.1128/CVI.00546-14",
language = "English",
volume = "22",
pages = "267 -- 273",
journal = "Clinical and Vaccine Immunology",
issn = "1556-6811",
publisher = "American Society for Microbiology",
number = "3",

}

Wressnigg, N, van der Velden, MVW, Portsmouth, D, Draxler, W, O'Rourke, M, Richmond, P, Hall, S, McBride, WJ, Redfern, AD, Aaskov, J, Barrett, PN & Aichinger, G 2015, 'An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial', Clinical and Vaccine Immunology, vol. 22, no. 3, pp. 267 - 273. https://doi.org/10.1128/CVI.00546-14

An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial. / Wressnigg, Nina; van der Velden, Maikel V W; Portsmouth, Daniel; Draxler, Wolfgang; O'Rourke, Maria; Richmond, Peter; Hall, Stephen; McBride, William John; Redfern, Andrew D; Aaskov, John; Barrett, P Noel; Aichinger, Gerald.

In: Clinical and Vaccine Immunology, Vol. 22, No. 3, 2015, p. 267 - 273.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - An inactivated Ross River virus vaccine is well tolerated and immunogenic in an adult population in a randomized phase 3 trial

AU - Wressnigg, Nina

AU - van der Velden, Maikel V W

AU - Portsmouth, Daniel

AU - Draxler, Wolfgang

AU - O'Rourke, Maria

AU - Richmond, Peter

AU - Hall, Stephen

AU - McBride, William John

AU - Redfern, Andrew D

AU - Aaskov, John

AU - Barrett, P Noel

AU - Aichinger, Gerald

PY - 2015

Y1 - 2015

N2 - 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- g 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 welltolerated 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.)

AB - 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- g 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 welltolerated 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.)

UR - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4340901/

U2 - 10.1128/CVI.00546-14

DO - 10.1128/CVI.00546-14

M3 - Article

VL - 22

SP - 267

EP - 273

JO - Clinical and Vaccine Immunology

JF - Clinical and Vaccine Immunology

SN - 1556-6811

IS - 3

ER -