Technology ID
TAB-985

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

E-Numbers
E-259-2004-3
E-259-2004-2
Lead Inventor
Golding, Hana (FDA)
Co-Inventors
Khurana, Surender (FDA)
Applications
Diagnostics
Therapeutic Areas
Infectious Disease
Lead IC
FDA
ICs
FDA
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.
Commercial Applications
  • Vaccine efficacy studies; Detection of early seroconversion in vaccine recipients
  • Distinguishing between healthy vaccine recipients and natural HIV infection
  • Blood bank screening
Competitive Advantages
Cost effective method to determine vaccines efficacy in clinical studies.
Licensing Contact:
Ronnenberg, William
wronnenberg@mail.nih.gov
Phone: 240-402-4561