The United States of America, as Represented by the Secretary, Department of Health and Human Services

Melbourne Health

Fundacion Investigacion Y Educacion En Sida

Berta Rodes

Hsi Liu

Bret M Steiner

Angeline Ingrid Bartholomeusz

Julie Sheldon

Vincent Soriano

The present invention relates generally to viral variants exhibiting reduced sensitivity to particular agents and/or reduced interactivity with immunological reagents. More particularly, the present invention is directed to hepatitis B virus (HBV) variants exhibiting complete or partial resistance to nucleoside or nucleotide analogs or other antagonists of HBV DNA polymerase activity and/or reduced interactivity with antibodies to viral surface components including reduced sensitivity to these antibodies. The present invention further contemplates assays for detecting such viral variants. These assays are useful in monitoring anti-viral therapeutic regimens and in developing new or modified vaccines directed against viral agents and in particular the resistant HBV variants of the present invention. The present invention also contemplates the use of the viral variants to screen for agents capable of inhibiting infection, replication and/or release of the virus.

Variants of hepatitis B virus with resistance to anti-viral nucleoside agents and applications thereof

Methods for the specific and highly sensitive detection ofinfection comprising the use of specific antigenic proteins and peptides unique toare provided. In particular, detection assays based on recognition of acidic repeat protein are provided. The methods of the present invention are useful for detection of primary syphilis at early stages of infection. In addition, the methods and compositions disclosed herein are directed to the differential detection of specificinfections enabling the identification of causative agents for specificdisease states: syphilis (subspecies), yaws (subspeciesCDC-1 or CDC-2 strain), and bejel (subspecies).

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Methods for the specific and highly sensitive detection ofinfection comprising the use of specific antigenic proteins and peptides unique toare provided. In particular, detection assays based recognition of acidic repeat protein are provided. The methods of the present invention are useful for detection of primary syphilis at early stages of infection. In addition, the methods and compositions disclosed herein are directed to the differential detection of specificinfections enabling the identification of causative agents for specificdisease states: syphilis (subspecies), yaws (subspeciesCDC-1 or CDC-2 strain), and bejel (subspecies).

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Madrid, Spain

Berta Rodes