Cell culture of hepatitis A virus

A Propagated hepatitis A virus, not previously passaged in a non-human primate, propagated by sequential passage comprising hepatitis A virus, in a first passage stage comprising primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of human or non-human primate origin;

• and in a second passage stage comprising diploid fibroblast cells derived from human or non-human primate lung tissue;
• the inoculum for which was a hepatitis A virus inoculum derived from a human clinical specimen or an inoculum from a hepatitis A virus passaged cell culture whose initial cell culture inoculum was a hepatitis A virus inoculum derived from a human clinical specimen.

A cell culture comprising hepatitis A virus in (i) primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of human or non-human primate origin;

• or in (ii) diploid fibroblast cells derived from human or non-human primate lung tissue;
• the inoculum for which was a hepatitis A virus inoculum derived from a human clinical specimen without passage in a non-human primate host or an inoculum from a hepatitis A virus passaged cell culture whose initial cell culture inoculum was a hepatitis A virus inoculum derived from a human clinical specimen without passage in a non-human primate host.

An infected cell culture harvest comprising hepatitis A virus which was propagated in a cell culture of (i) primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of human or non-human primate origin;

• or (ii) diploid fibroblast cells derived from human or non-human primate lung tissue;
• using as an inoculum a hepatitis A virus inoculum derived from a human clinical specimen without passage in a non-human primate host or an inoculum from a hepatitis A virus passaged cell culture whose initial cell culture inoculum was a hepatitis A virus inoculum derived from a human clinical specimen without passage in a non-human primate host.

A hepatitis A vaccine comprising attenuated, inactivated hepatitis A virus from a cell culture of (i) primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of human or non-human primate origin;

• or (ii) diploid fibroblast cells derived from human or non-human primate lung tissue;
• wherein the hepatitis A virus had not been passaged through a non-human primate prior to cell culture.

A hepatitis A vaccine comprising hepatitis A virus passaged in a first passage stage comprising 5 passages in cell culture of primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of human or non-human primate origin;

• or (ii) diploid fibroblast cells derived from human or non-human primate lung tissue;
• wherein the hepatitis A virus was not passaged through a non-human primate prior to cell culture.

Propagated hepatitis A virus, not previously passaged in a non-human primate, propagated by cell culture passage of hepatitis A virus in:

• (i) primary, continuously cultivated, or transformed cells derived from kidney or liver of non-human primate origin;
• and (ii) diploid fibroblast cells derived from human lung tissue;
• the inoculum for which was a hepatitis A inoculum from a human clinical specimen comprising hepatitis A virus or an inoculum from a hepatitis A virus passaged cell culture whose initial cell culture inoculum was a hepatitis A virus inoculum derived from a human clinical specimen.

Propagated hepatitis A virus, having been previously propagated in cell culture, said virus not having been passaged in a non-human primate, wherein said virus was propagated by cell culture in:

• (i) primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of non-human primate origin;
• and (ii) diploid fibroblast cells derived from human lung tissue.

A cell culture of hepatitis A virus, wherein the hepatitis A virus had been previously propagated in:

• (i) primary, continuously cultivated, or transformed cells derived from kidney or liver tissue of non-human primate origin;
• and (ii) in diploid fibroblast cells derived from human lung tissue, wherein the inoculum for (i) was a hepatitis A virus inoculum derived from a human clinical specimen without passage in a non-human primate host or an inoculum from a hepatitis A virus passaged cell culture whose initial cell culture inoculum was a hepatitis A virus inoculum derived from a human clinical specimen.