HIV-1 Infection Detection Assay for Seroconverted HIV-1 Vaccine Recipients
Description of Invention:
Available for licensing and commercial distribution is an assay method and kit having diagnostic peptide fragments derived from human immunodeficiency virus-1 (HIV-1). The new serology assay includes HIV-1 peptide fragments epitopes that map to HIV-1 GAG-p6, and gp41 genes. These epitopes are broadly reactive with early sera from HIV infected individuals, do not illicit protective antibodies, do not illicit immunologic cytotoxicity and are readily removable from current and future HIV-1 candidates. The assay is advantageous in detecting HIV-1 early breakthrough infections in seroconverted vaccine recipients while being able to distinguish between individuals with bonafide breakthrough infections versus non-HIV infected vaccine recipients presenting only vaccine borne antibodies. For example, 90% of vaccine recipients receiving a Canarypox construct expressing a plurality of HIV antigens (Env, Gag, Pol, HIV Protease, Nef) followed by an envelope protein boost, scored positive in FDA licensed enzyme immunoassay, rapid test, and Western blot (Marta-Louise Ackers et al., J Infect Dis. 187:879 (2003)). Such seroconversion has a negative impact on phase III efficacy trials of prophylactic HIV vaccines that require early detection of breakthrough infections and also exclude non-HIV infected vaccine recipients from the pool of potential blood donors.
Inventors:
Hana Golding and Surender Khurana (FDA/CBER)
For Additional Information Please Contact: Michael Shmilovich J.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301) 435-5019
Email: shmilovm@mail.nih.gov
Fax: (301) 402-0220
