The preclinical testing of a formaldehyde inactivated Ross River virus vaccine designed for use in humans.
Ross River virus was grown in industrial facilities in vaccine-certified Vero cells in the absence of serum, inactivated using standard formalin-inactivation protocols, treated with Benzonase to digest host cell DNA and purified on a sucrose gradient. Mice given two subcutaneous injections of 0.625 microg of this vaccine or two doses of 0.156 microg vaccine with aluminium hydroxide adjuvant failed to develop a detectable viraemia after intravenous challenge with 10(6)TCID50 of the prototype strain of Ross River virus (T48). Guinea pigs immunised with one or two10 microg doses of vaccine with adjuvant also failed to develop a detectable viraemia following a similar challenge. The levels of neutralising antibody (neutralisation index 1.9-3.1) in the mice protected against challenge with 10(6)TCID50 Ross River virus were similar to those in 16 former epidemic polyarthritis patients (1.1-3.5) who had not experienced a second clinical infection with Ross River virus in the 20 years following their initial infection.
Kistner
Otfried
O
Biomedical Research Center, Baxter Vaccine AG, Uferstrasse 15, A-2304 Orth/Donau, Austria.
Barrett
Noel
N
Brühmann
Axel
A
Reiter
Manfred
M
Mundt
Wolfgang
W
Savidis-Dacho
Helga
H
Schober-Bendixen
Susanne
S
Dorner
Friedrich
F
Aaskov
John
J
D000276:Adjuvants, Immunologic / Q000494:pharmacology; D018354:Alphavirus Infections / Q000517:prevention & control*; D000818:Animals; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D002522:Chlorocebus aethiops; D004353:Drug Evaluation, Preclinical; D004591:Electrophoresis, Polyacrylamide Gel; D004797:Enzyme-Linked Immunosorbent Assay; D005557:Formaldehyde; D006168:Guinea Pigs; D006801:Humans; D007114:Immunization; D007075:Immunoglobulin M / Q000032:analysis / Q000096:biosynthesis; D008854:Microscopy, Electron; D012398:Ross River virus / Q000276:immunology*; D015164:Vaccines, Inactivated / Q000276:immunology; D014709:Vero Cells; D010948:Viral Plaque Assay; D014764:Viral Proteins / Q000032:analysis / Q000096:biosynthesis; D014765:Viral Vaccines / Q000276:immunology* / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007075:Immunoglobulin M; D015164:Vaccines, Inactivated; D014764:Viral Proteins; D014765:Viral Vaccines; D005557:Formaldehyde