Claims for Patent: 5,230,997

Summary for Patent: 5,230,997

Title:	Methods of detecting the presence of human herpesvirus-7 infection
Abstract:	The present invention relates to a new human herpesvirus-7, proteins encoded in the genome of the virus, and antibodies specific for the virus and proteins. The virus was isolated from human peripheral blood mononuclear cells following incubation of the cells under conditions promoting T cell activation. Cultures of lymphocytes infected with the virus exhibited a cytopathic effect and electron microscopic analyses revealed a characteristic herpesvirus structure. The new virus is distinct from previously characterized human herpesviruses. The invention also relates to bioassays for the diagnosis of human herpesvirus-7 and the detection of human herpesvirus-7 in a biological sample. It further relates to a vaccine for humans against human herpesvirus-7.
Inventor(s):	Frenkel; Niza (Rockville, MD)
Assignee:	The United States of America as represented by the Department of Health (Washington, DC)
Application Number:	07/553,798
Patent Claims:	1. A method for the diagnosis of human herpesvirus-7 infection in a human patient, comprising the steps of: ii) coating a substrate surface with a human herpesvirus-7 structural antigen ii) contacting said surface with serum suspected of containing human herpesvirus-7 specific antibodies from said human patient and iii) detecting the presence or absence of a complex formed between said antigen and antibodies specific thereof, if present in said serum, wherein the presence of said complex indicates the presence of said infection. 2. The method of claim 1 wherein said complex is detected by biotinylated antibodies. 3. The method of claim 2 wherein said biotinylated antibodies are detected by streptavidin. 4. The method of claim 1 wherein said complex is detected with fluorescein conjugated anti-human immunoglobulin G. 5. The method of claim 1 wherein said substrate surface is a gel, a slide, membrane, a microtitration plate, or column material. 6. The method of claim 1, wherein said antigen is displayed on the surface of human herpesvirus-7. 7. A method for the diagnosis of human herpesvirus-7 infection in a human patient, comprising the steps of: i) coating a surface with antibodies a human herpesvirus-7 structural antigen; ii) obtaining a biological sample from said patient; iii) contacting said surface with said sample; and iv) detecting the presence or absence of a complex formed between said antibodies and virus, if present in said sample, wherein the presence of said complex indicates the presence of said infection in said patient. 8. The method of claim 7, wherein said antigen is displayed on the surface of human herpesvirus-7. 9. A method of detecting the presence of human herpesvirus-7 infection in a patient, comprising the steps of: obtaining a sample of serum suspected of containing herpesvirus-7 specific antibodies from said patient; contacting said sample of serum with a human herpesvirus-7 structural antigen; and determining if specific binding has occurred between said antigen and the antibodies, if contained in said serum sample, wherein the presence of said specific binding indicates the presence of human herpesvirus-7 infection in said patient. 10. The method of claim 9, wherein the determining step comprises a test selected from the group consisting of IFA, immunoblots, RIA, RIST, ELISA, agglutination and hemagglutination. 11. The method of claim 9, wherein said antigen comprises an immunogenic protein of human herpesvirus-7 having a molecular weight of approximately 83 kilodaltons. 12. The method of claim 9, wherein the contacting step comprises contacting said serum with proteins from human herpesvirus-7 infected cells. 13. The method of claim 12, additionally comprising electrophoresing said proteins from human herpesvirus-7 infected cells prior to the contacting step. 14. The method of claim 13, wherein the determining step comprises determining whether any antibodies in said serum component have specifically bound to protein having an apparent molecular weight of approximately 83 kilodaltons in the electrophoresis system used for the electrophoresis step. 15. The method of claim 13, wherein the electrophoresing step comprises subjecting said proteins to polyacrylamide gel electrophoresis, resulting in a gel with separated proteins, additionally comprising blotting the proteins in said gel to another material. 16. The method of claim 15, wherein the contacting step comprises a first contacting step wherein said serum is contacted with said material. 17. The method of claim 16, additionally comprising a second contacting step wherein antibodies specific for human herpesvirus-7 specific antibodies are contacted with said material, said second contacting step being performed subsequently to said first contacting step. 18. The method of claim 17, wherein the determining step comprises determining whether said antibodies specific for human herpesvirus-7 specific antibodies are specifically bound to said material. 19. The method of claim 17, wherein said antibodies specific for human herpesvirus-7 specific antibodies carry a label. 20. The method of claim 19, wherein said label comprises biotin. 21. A method of detecting the presence of human herpesvirus-7 infection in a patient, comprising the steps of: obtaining a biological sample from said patient; contacting said biological sample with an antibody specific to a human herpesvirus-7 structural antigen; determining if specific binding has occurred between said antibody and said antigen present in said sample, wherein the presence of said specific binding indicates the presence of human herpesvirus-7 infection in said patient. 22. A monoclonal antibody specific for a human herpesvirus-7 structural antigen, but not for other human herpesviruses. 23. An isolated antibody that specifically binds to a human herpesvirus-7 structural antigen, but not to any other herpesviruses. 24. An antibody according to claim 23, wherein said antibody does not specifically bind to any exposed epitope of human herpesvirus-6. 25. An antibody according to either claim 22 or claim 23, wherein said antibody is specific for an antigen displayed on the surface of human herpesvirus-7. 26. An antibody according to either claim 22 or claim 23, wherein said antigen is a protein encoded by human herpesvirus-7 DNA .

Details for Patent 5,230,997

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2040-01-28
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2040-01-28
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2040-01-28
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2040-01-28
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		2040-01-28
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	02/06/2017		2040-01-28