HIV-1 Infection Detection Assay for Seroconverted HIV-1 Vaccine Recipients


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.

Potential Commercial Applications: Competitive Advantages:
  • Vaccine efficacy studies; Detection of early seroconversion in vaccine recipients
  • Distinguishing between healthy vaccine recipients and natural HIV infection
  • Blood bank screening
 Cost effective method to determine vaccines efficacy in clinical studies.


Inventors:

Hana Golding (FDA)  ➽ more inventions...

Surender Khurana (FDA)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 7,888,003 issued 2011-02-15
U.S. Pat: 8,722,324 issued 2014-05-13
U.S. Pat: 9,121,855 issued 2015-09-01
U.S. Pat: 8,980,546 issued 2015-03-17
US Application No. 12/977,320
US Application No. 12/977,481
US Application No. 12/977,411
US Application No. 13/321,676
and related international patents/patent applications

Publications:
Khurana S, et al. PMID 16474117
Khurana S, et al. PMID 17019363
Khurana S, et al. PMID 19906903

Licensing Contact:
William Ronnenberg, M.S., J.D.
Email: william.ronnenberg@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-259-2004-2
Updated: Jul 31, 2012