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J Virol 2006 Mar;80(5):2092-9

Human Immunodeficiency Virus (HIV) Vaccine Trials: a Novel Assay for Differential Diagnosis of HIV Infections in the Face of Vaccine-Generated Antibodies.

Khurana S, Needham J, Mathieson B, Rodriguez-Chavez IR, Catanzaro AT, Bailer RT, Kim J, Polonis V, Cooper DA, Guerin J, Peterson ML, Gurwith M, Nguyen N, Graham BS, Golding H

Golding H, Ctr Biol Evaluat & Res, Div Viral Prod, FDA, Bethesda, MD 20892 USA Ctr Biol Evaluat & Res, Div Viral Prod, FDA, Bethesda, MD 20892 USA Ctr Biol Evaluat & Res, Core Facil, FDA, Bethesda, MD 20892 USA NIH, Off AIDS Res, Bethesda, MD 20892 USA NIAID, Vaccine Clin Res Branch, Div AIDS, NIH, Bethesda, MD 20892 USA NIAID, Vaccine Res Ctr, NIH, Bethesda, MD 20892 USA USAMC, Armed Forces Res Inst Med Sci, APO, AP 96546 USA US Mil HIV Res Program, Rockville, MD 20850 USA Univ New S Wales, Natl Ctr HIV Epidemiol & Clin Res, Sydney, NSW 2010, Australia VaxGen Inc, Brisbane, CA 94005 USA


All current human immunodeficiency virus (HIV) vaccine candidates contain multiple viral components and elicit antibodies that react positively in licensed HIV diagnostic tests, which contain similar viral products. Thus, vaccine trial participants could be falsely diagnosed as infected with HIV. Additionally, uninfected, seropositive vaccinees may encounter long-term social and economic harms. Moreover, this also interferes with early detection of true HIV infections during preventive HIV vaccine trials. An HIV-seropositive test result among uninfected vaccine trial participants is a major public health concern for volunteers who want to participate in future HIV vaccine trials. Based on the increased number of HIV vaccines being tested globally, it is essential to differentiate vaccine- from virus-induced antibodies. Using a whole-HIV-genome phage display library, we identified conserved sequences in Env-gp41 and Gag-p6 which are recognized soon after infection, do not contain protective epitopes, and are not part of most current HIV vaccines. We established a new HIV serodetection assay based on these peptides. To date, this assay, termed HIV-SELECTEST, demonstrates >99% specificity and sensitivity. Importantly, in testing of plasma samples from multiple HIV vaccine trials, uninfected trial participants scored negative, while all intercurrent infections were detected within 1 to 3 months of HIV infection. The new HIV-SELECTEST is a simple but robust diagnostic tool for easy implementation in HIV vaccine trials and blood banks worldwide.

Category: Journal Article
PubMed ID: #16474117
PubMed Central ID: #PMC1395407
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2011-10-04 Entry Last Modified: 2012-08-29