HIV-1 Infection Detection Assay for Seroconverted HIV-1 Vaccine Recipients
Posted Jan 21 2010 4:00pm
Description of Invention: Available for licensing and commercial distribution is a serological test specifically designed to distinguish between antibodies generated in HIV vaccine recipients and those generated in a natural HIV infection. The method is useful in HIV vaccine development and clinical studies as it can readily detect early breakthrough infections in seroconverted vaccine recipients, thus providing the information required to determine vaccine efficacy. The test kit includes diagnostic peptide fragments derived from human immunodeficiency virus-1 (HIV-1). The peptide epitopes are primarily derived from the GAG-p6 and gp41 genes. These epitopes are broadly reactive with early sera from HIV infected individuals, but do not illicit protective antibodies, or immunologic cytotoxicity, and thus can readily be excluded from current and future HIV-1 vaccine candidates.
Applications:
Vaccine efficacy studies; Detection of early seroconversion in vaccine recipients
Distinguishing between healthy vaccine recipients and natural HIV infection
Blood bank screening
Advantages: Cost effective method to determine vaccines efficacy in clinical studies.
Inventors: Hana Golding (FDA) Surender Khurana (FDA)
and related international patents/patent applications
Relevant Publication:
S Khurana et al. Human immunodeficiency virus (HIV) vaccine trials: a novel assay for differential diagnosis of HIV infections in the face of vaccine-generated antibodies. J Virol. 2006 March;80(5): 2092-2099. [ PubMed: 16474117 ]
S Khurana et al. Novel approach for differential diagnosis of HIV infections in the face of vaccine-generated antibodies: utility for detection of diverse HIV-1 subtypes. J Acquir Immune Defic Syndr. 2006 Nov 1;43(3):304-312. [ PubMed: 17019363 ]
S Khurana et al. HIV-SELECTEST EIA and rapid test: ability to detect seroconversion following HIV-1 infection. J Clin Microbiol. 2009 Nov 11. Epub ahead of print. doi:10.1128/JCM.01573-09. [ PubMed: 19906903 ]
For Additional Information Please Contact: Michael Shmilovich Esq. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: shmilovm@mail.nih.gov Phone: 301-435-5019 Fax: 301-402-0220
Description of Invention:
Available for licensing and commercial distribution is a serological test specifically designed to distinguish between antibodies generated in HIV vaccine recipients and those generated in a natural HIV infection. The method is useful in HIV vaccine development and clinical studies as it can readily detect early breakthrough infections in seroconverted vaccine recipients, thus providing the information required to determine vaccine efficacy. The test kit includes diagnostic peptide fragments derived from human immunodeficiency virus-1 (HIV-1). The peptide epitopes are primarily derived from the GAG-p6 and gp41 genes. These epitopes are broadly reactive with early sera from HIV infected individuals, but do not illicit protective antibodies, or immunologic cytotoxicity, and thus can readily be excluded from current and future HIV-1 vaccine candidates.
Applications:
Advantages:
Cost effective method to determine vaccines efficacy in clinical studies.
Inventors:
Hana Golding (FDA)
Surender Khurana (FDA)
Patent Status:
HHS, Reference No. E-259-2004/2
US, Application No. 11/662,370 filed 02 Sep 2005
PCT, Application No. PCT/US2005/031287 filed 02 Sep 2005
PCT, Application No. PCT/US2010/035801 filed 21 May 2010
and related international patents/patent applications
Relevant Publication:
Licensing Status:
Available for licensing.
Portfolios:
Infectious Diseases
Infectious Diseases - Diagnostics
Miscellaneous
For Additional Information Please Contact:
Michael Shmilovich Esq.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: shmilovm@mail.nih.gov
Phone: 301-435-5019
Fax: 301-402-0220
Ref No: 985
Updated: 01/2010