Scientific Publications by FDA Staff

J Acquir Immune Defic Syndr 2006 Nov 1;43(3):304-12

Novel Approach for Differential Diagnosis of HIV Infections in the Face of Vaccine-Generated Antibodies: Utility for Detection of Diverse HIV-1 Subtypes.

Khurana S, Needham J, Park S, Mathieson B, Busch MP, Nemo G, Nyambi P, Zolla-Pazner S, Laal S, Mulenga J, Chomba E, Hunter E, Allen S, McIntyre J, Hewlett I, Lee S, Tang S, Cowan E, Beyrer C, Altfeld M, Yu XG, Tounkara A, Koita O, Kamali A, Nguyen N, Graham BS, Todd D, Mugenyi P, Anzala O, Sanders E, Ketter N, Fast P, Golding H

Golding H (reprint author), FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Room 1A21,Bldg 29A,8800 Rockville Pike, Bethesda, MD 20892 USA FDA, Ctr Biol Evaluat & Res, Div Viral Prod, Bethesda, MD 20892 USA NIH, Off Aids Res, Bethesda, MD 20892 USA Blood Syst Res Inst, San Francisco, CA USA NHLBI, NIH, Bethesda, MD 20892 USA NYU, Sch Med, Dept Pathol, New York, NY USA Zambia Emory HIV Res Project, Lusaka, Zambia Zambia Blood Transfus Serv, Lusaka, Zambia Emory Vaccine Res Ctr, Atlanta, GA USA Emory Univ, Sch Publ Hlth, Atlanta, GA USA Univ Witwatersrand, Chris Hani Baragwanath Hosp, Johannesburg, South Africa FDA, Div Emerging & Transfus Transmitted Dis, Bethesda, MD USA Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Epidemiol, Baltimore, MD USA MA Gen Hosp, Partners AIDS Res Ctr, Charlestown, MA USA Univ Bamako, Bamako, Mali FDA, CBER, Core Facil, Bethesda, MD USA NIAID, Vaccine Res Ctr, NIH, Bethesda, MD 20892 USA Westat Corp, Rockville, MD USA Joint Clin Res Ctr, Mengo, Uganda Int AIDS Vaccine Initiat, New York, NY USA Univ Nairobi, Nairobi, Kenya Ctr Geog Med Cost Res, Kilifi, Kenya

Because increasing numbers of HIV vaccine candidates are being tested globally, it is essential to differentiate vaccine-from virus-induced antibodies. Most of the currently tested vaccines contain multiple viral components. As a result, many vaccine recipients give positive results in FDA-licensed HIV serodetection tests. We have identified conserved sequences in Env-gp41 and Gag-p6, which are recognized soon after infection but are not included in most HIV vaccine candidates. A new HIV serodetection assay, the HIV-SELECTEST, was established that distinguishes between vaccineinduced antibodies and seroconversion due to true HIV infections. It is important to make this assay globally relevant, because many clinical trials are conducted around the world where most HIV infections are due to non-B subtype HIV-1. Therefore, the current study examined the reactivity of plasma samples from >3000 infections with diverse HIV subtypes worldwide. The HIV-SELECTEST performed at >99% specificity and sensitivity. Both recent and established infections with clades A, B, C, D, E, F, G, J, and CRFs were detected. Antibodies elicited by other vaccinations or infections endemic to the clinical trial sites did not react in this assay. Therefore, HIV-SELECTEST could be an important differential diagnostic tool for HIV vaccine trials, blood banks, and population screening worldwide.