Performance of a Redesigned HIV Selectest Enzyme-Linked Immunosorbent Assay Optimized To Minimize Vaccine-Induced Seropositivity in HIV Vaccine Trial Participants

Penezina, Oksana; Krueger, Neil X.; Rodriguez-Chavez, Isaac R.; Busch, Michael P.; Kim, Jerome H.; O’Connell, Robert J.; Hunter, Eric; Aboud, Said; Higgins, Keith; Kovalenko, V. A.; Clapham, David; Crane, David; Levin, Andrew

doi:10.1128/cvi.00748-13

Cited by 14 publications

(10 citation statements)

References 30 publications

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“…The tool is undergoing redevelopment to improve its function across multiple clades of HIV-1 virus, so that it can be used to help manage global aspects of the HIV epidemic. 44 Although still under development, it is expected to be used in upcoming large HIV vaccine clinical trials.…”

Section: Research To Improve Clinical Trialsmentioning

confidence: 99%

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Obias-Manno

Scott

Kaczmarczyk

et al. 2016

Journal of Women's Health

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The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

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Section: Research To Improve Clinical Trialsmentioning

confidence: 99%

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Obias-Manno

Scott

Kaczmarczyk

et al. 2016

Journal of Women's Health

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“…Several small companies are making good progress toward differential tests. One such example is HIV-Selectest 9–11 , which is being developed by Immunetics, Inc. HIV-Selectest detects antibodies to a region in gp41 that is rarely included in vaccine immunogens and can therefore be used for differential serologic testing. HIV-Selectest has been tested against specimens from a number of clinical trials with good results 11,12 .…”

Section: Scope Of the Problemmentioning

confidence: 99%

HIV vaccine-induced sero-reactivity: A challenge for trial participants, researchers, and physicians

Zinszner

Karg

Brooks

et al. 2015

Vaccine

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Antibody-inducing vaccines are a major focus in the preventive HIV vaccine field. Because the most common tests for HIV infection rely on detecting antibodies to HIV, they may also detect antibodies induced by a candidate HIV vaccine. The detection of vaccine-induced antibodies to HIV by serological tests is most commonly referred to as vaccine-induced sero-reactivity (VISR). VISR can be misinterpreted as a sign of HIV infection in a healthy study participant. In a participant who has developed vaccine-induced antibodies, accurate diagnosis of HIV infection (or lack thereof) may require specialized tests and algorithms (differential testing) that are usually not available in community settings. Organizations sponsoring clinical testing of preventive HIV vaccine candidates have an ethical obligation not only to inform healthy volunteers about the potential problems associated with participating in a clinical trial but also to help manage any resulting issues. This article explores the scope of VISR-related issues that become increasingly prevalent as the search for an effective HIV vaccine continues and will be paramount once a preventive vaccine is deployed. We also describe ways in which organizations conducting HIV vaccine trials have addressed these issues and outline areas where more work is needed.

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“…This test is based on consensus and clade‐specific HIV peptides that are omitted in HIV‐vaccine constructs. The assay, originally developed by FDA scientists, has recently been redesigned to enhance performance across worldwide clades and to simplify routine use via a standard kit format . Based on testing of sera from vaccine trial participants, HIV‐infected and uninfected individuals and healthy controls, the HIV Selectest demonstrated 99.5% specificity with sera from uninfected recipients of six different HIV vaccines and 100% specificity with normal donors, while detecting HIV‐1 infected individuals including intercurrent vaccine‐breakthrough infections at 95–100% sensitivity depending on clade, with the highest sensitivity for clades A and C. The HIV Selectest provides a new laboratory tool for use in vaccine settings to distinguish the immune response to HIV‐vaccine antigens from that due to true infection and potentially may be important for blood‐donor screening.…”

Section: Evolution and Progressive Impact Of Hiv Serological Assays Tmentioning

confidence: 99%

Testing for HIV – the first three decades

Busch

2015

ISBT Science Series

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Background HIV was discovered in 1984, with high rates of virus isolation and antibody (Ab) detection in haemophiliacs and recipients of blood from HIV‐infected donors, demonstrating the critical need to develop tests for donor screening. Aims/Methods Review evolution of HIV‐donor screening, and broader applications of HIV tests and infected‐donor surveillance to research and public health. Results In mid‐1984, scientists in governments and industry collaborated to develop HIV‐Ab tests that were implemented in blood banks ~1 year following discovery of HIV. Initial Ab screening did not eliminate TT‐HIV, however, with numerous breakthrough cases detected following introduction of first‐generation assays, which were determined to have an infectious pre‐seroconversion (SC) window period (WP) of ~56 days. Improvements in sensitivity of second‐generation tests in the late‐1980s and third‐generation tests in the mid‐1990s reduced the pre‐SC WP to approximately 3 weeks. Subsequent additions of p24 antigen and then nucleic acid technology (NAT)‐screening in the late 1990s closed the infectious WP to 5–10 days. NAT‐screening assays and algorithms and fourth‐generation Ag/Ab serological tests developed for blood bank screening and staging of early HIV infections are now in widespread use in clinical diagnostic, research and public health settings. NAT assays developed for donor screening have been applied to detect persistent low‐level viral replication in studies of patients on HAART, ‘elite controllers’ and ‘HIV‐eradication’ research. Conclusions Progressive improvements in HIV screening assays have virtually eliminated TT‐HIV infections, and consequent advances in HIV testing have contributed to HIV diagnostics, research and public health.

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Performance of a Redesigned HIV Selectest Enzyme-Linked Immunosorbent Assay Optimized To Minimize Vaccine-Induced Seropositivity in HIV Vaccine Trial Participants

Cited by 14 publications

References 30 publications

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

HIV vaccine-induced sero-reactivity: A challenge for trial participants, researchers, and physicians

Testing for HIV – the first three decades

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