Kits for the detection of human immunodeficiency virus type...

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Reexamination Certificate

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C530S387100, C435S005000, C435S810000, C436S513000, C436S548000

Reexamination Certificate

active

06296807

ABSTRACT:

The invention relates to new virus forms capable of causing lymphadenopathies which are capable of then developing into acquired immuno-deficiency syndrome (AIDS). The invention also applies to antigens which may be obtained from these viruses and other viruses having certain properties in common with them. It also concerns antibodies which may be induced against these various antigens. Lastly, the invention relates to using these antigens or antibodies in diagnosing certain AIDS forms and, with respect to some of these AIDS forms, to producing immunizing and vaccinating compositions against these retroviruses such as purified proteins, glyco-proteins, recombinant proteins or synthetic peptides.
An article by F. Barre-Sinoussi et al. in Science, Vol 220: pp 868-871 [1983] describes the isolation of the first retrovirus which was known to be responsible for AIDS. European Patent Application 138,667 specifically describes diagnosis of AIDS and pre-AIDS by detection of the presence of antibodies against the virus through the use of certain virus extracts and particularly through the use of some of the viral proteins. This retrovirus is known generally as LAV. Since that time, other similar strains and variations of LAV have been isolated. Illustrative strains include HTLV-III and ARV. The expression “LAV-I” has been coined to cover these designations and the corresponding viral strains. Thus, the set of viruses which are identical with or close to the initial isolate shall be called herein “LAV type 1” or “LAV-I”.
The “LAV” set may be defined as a set of viruses either causing generalized and persistent polyadenopathies, or AIDS, and having in vitro a tropism for T4 cells wherein this retrovirus induces a cytopathogenic effect. These retroviruses have been found to be distinct from the other already known human retoviruses (HTLV-I and HTLV-II).
Even though the LAV virus does vary genetically rather substantially, the diverse strains isolated to-date from African, Haitian, European and American patients have in common certain antigen sites on their main proteins: p25 core protein; gp 110 envelope glyco-protein; and gp 41-43 transmembrane protein. As a result, the prototype strain LAV-I deposited at COLLECTION NATIONALE DES CULTURES DE MICRO-ORGANISMES (CNCM) under No. 1-232 may be used as an antigen strain to detect antibodies for all types of affiliated patients regardless of origin. For example, the HTLV-III virus isolated by R. C. Gallo et al. which is presently being used to detect antibodies in blood donors and patients by means of ELISA, immunofluorescence, and “Western blot” (or immuno-print) techniques and RIPA (radio immuno-precipitation assay).
However it was found in serological research on patients; native to Guinea-Bissau and hospitalized in Portugal that some had seronegative or very weakly positive reactions to these tests using an LAV-I lysate, whereas they evinced the clinical and immunological symptoms of AIDS.
Starting with the cultured lymphocytes from one of these patients, a retrovirus was isolated which structure, when examined under the electron microscope, and protein contour in the SDS electrophoresis gel were generally even similar in their properties to those of LAV-I, however, this retrovirus is less related to the LAV-I both as regards the antigenic homology of its proteins and the homology of its genetic material than the other, previously identified LAV strains.


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Kanki et al., “Serologic Identification and Characterization of a Macaque T-Lymphotropic Retrovirus Closely Related to HTLV-III,”Science, 228, 1199-1201 (1985).
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