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Journal of Virology, March 2006, p. 2092-2099, Vol. 80, No. 5
0022-538X/06/$08.00+0     doi:10.1128/JVI.80.5.2092-2099.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

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

Surender Khurana,1 James Needham,1 Bonnie Mathieson,2 Isaac R. Rodriguez-Chavez,3 Andrew T. Catanzaro,4 Robert T. Bailer,4 Jerome Kim,5 Vicky Polonis,6 David A. Cooper,7 Jan Guerin,7 Michael L. Peterson,8 Marc Gurwith,8 Nga Nguyen,9 Barney S. Graham,4 Hana Golding,1* the HIV Vaccine Trial Network

Division of Viral Products,1 Core Facility, Center for Biologics Evaluation and Research (CBER), FDA, Bethesda, Maryland 20892,9 Office of AIDS Research, NIH, Bethesda, Maryland 20892,2 Vaccine Clinical Research Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892,3 Vaccine Research Center, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892,4 U.S. Army Medical Component-Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS), APO AP 96546,5 U.S. Military HIV Research Program, Rockville, Maryland 20850,6 National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia 2010,7 VaxGen, Inc., Brisbane, California 940058

Received 19 October 2005/ Accepted 3 December 2005

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.

* Corresponding author. Mailing address: Division of Viral Products, Center for Biologics Evaluation and Research (CBER), FDA, Bethesda, MD 20892. Phone: (301) 827-0784. Fax: (301) 496-1810. E-mail: goldingh{at}cber.FDA.gov.

Journal of Virology, March 2006, p. 2092-2099, Vol. 80, No. 5
0022-538X/06/$08.00+0     doi:10.1128/JVI.80.5.2092-2099.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Corey, L. (2009). CDC Recommendations for Opt-Out HIV Testing. JAMA 301: 274-275 [Full Text]  


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