Sanofi Pasteur Inc.

Aventis Pasteur Limited

Connaught Laboratories Limited

Sonia E Sanhueza

Michel Henri Klein

Mary E Ewasyshyn

Raymond P Oomen

George A Cates

An immunogenic composition capable of producing a respiratory syncytial (RS) virus specific immune response in a host immunized therewith comprises purified, inactivated RS virus which is substantially free from cellular and serum components and which is non-infectious, non-immunopotentiating, immunogenic and protective. The virus is grown on a vaccine quality cell line and harvested virus is purified under non-denaturing conditions to be substantially free from cellular and serum components. The purified RS virus is inactivated using &#x3b2;-propiolactone, a non-ionic detergent, particularly n-octyl-&#x3b1;-D-glucopyranoside and n-octyl-&#x3b2;-D-glucopyranoside, or ascorbic acid. The immunogenic composition may be formulated as a vaccine for in vivo administration to a human host. The immunogenic composition also may be used in diagnostic applications.

Inactivated respiratory syncytial viral vaccines

An immunogenic composition capable of producing a respiratory syncytial (RS) virus specific immune response in a host immunized therewith comprises purified, inactivated RS virus which is substantially free from cellular and serum components and which is non-infectious, non-immunopotentiating, immunogenic and protective. The virus is grown on a vaccine quality cell line and harvested virus is purified under non-denaturing conditions to be substantially free from cellular and serum components. The purified RS virus is inactivated using &bgr;-propiolactone, a non-ionic detergent, particularly n-octyl-&agr;-D-glucopyranoside and n-octyl-&bgr;D-glucopyranoside, or ascorbic acid. The immunogenic composition may be formulated as a vaccine for in vivo administration to a human host. The immunogenic composition also may be used in diagnostic applications.

The fusion (F) protein, attachment (G) protein and matrix (M) protein of respiratory syncytial virus (RSV) are isolated and purified from respiratory syncytial virus by mild detergent extraction of the proteins from concentrated virus, loading the protein onto a hydroxyapatite or other ion-exchange matrix column and eluting the protein using mild salt treatment. The F, G and M proteins, formulated as immunogenic compositions, are safe and highly immunogenic and protect relevant animal models against decreased caused by respiratory syncytial virus infection.

Subunit respiratory syncytial virus vaccine preparation

The fusion (F) protein, attachment (G) protein and matrix (M) protein of respiratory syncytial virus (RSV) are isolated and purified from respiratory syncytial virus by mild detergent extraction of the proteins from concentrated virus, loading the protein onto a hydroxyapatite or other ion-exchange matrix column and eluting the protein using mild salt treatment. The F, G and M proteins, formulated as immunogenic compositions, are safe and highly immunogenic and protect relevant animal models against respiratory syncytial virus.

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Willowdale, Canada

Sonia E Sanhueza