Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types

In the clinical trials of the quadrivalent human papillomavirus (qHPV) vaccine, antibodies were measured by a competitive Luminex immunoassay (HPV-4 cLIA). A nine-valent HPV (9vHPV) vaccine targeting the types in the qHPV vaccine (HPV6/11/16/18), as well as 5 of the next most frequent HPV types foun...

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Bibliographic Details
Published in:Human vaccines & immunotherapeutics 2014-01, Vol.10 (8), p.2168-2174
Main Authors: Roberts, Christine, Green, Tina, Hess, Erica, Matys, Katie, Brown, Martha J, Haupt, Richard M, Luxembourg, Alain, Vuocolo, Scott, Saah, Alfred, Antonello, Joseph
Format: Article
Language:English
Subjects:
Animals
Antibodies, Monoclonal
Antibodies, Neutralizing - blood
Antibodies, Viral - blood
Antigens, Viral
Clinical Laboratory Techniques - methods
Cross Reactions
Humans
Immunoassay - methods
Immunoglobulin G - blood
Macaca mulatta
Papillomaviridae - immunology
Papillomavirus Infections - immunology
Papillomavirus Infections - virology
Sensitivity and Specificity
Short Report
Virosomes
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Summary:In the clinical trials of the quadrivalent human papillomavirus (qHPV) vaccine, antibodies were measured by a competitive Luminex immunoassay (HPV-4 cLIA). A nine-valent HPV (9vHPV) vaccine targeting the types in the qHPV vaccine (HPV6/11/16/18), as well as 5 of the next most frequent HPV types found in cervical cancers worldwide (HPV31/33/45/52/58) is under development. To support the 9vHPV vaccine program, a nine-multiplexed cLIA (HPV-9 cLIA) was developed. Antibody titers were determined in a competitive format, where type-specific phycoerythrin (PE)-labeled, neutralizing mAbs (mAbs-PE) compete with an individual's serum antibodies for binding to conformationally sensitive, neutralizing epitopes on the VLPs. Neutralizing antibody levels were quantitated against a reference standard - a pool of sera from 6 Rhesus macaques that were immunized with the 9vHPV vaccine. Specificity of the mAbs was assessed by measuring their individual binding capacities to the type-specific and non-type-specific VLPs at alternative concentrations of the mAbs. Antibody assignments to the HPV-9 cLIA reference standard for HPV6/11/16/18 were determined to provide for a measure of consistency in serostatus assignment between the HPV-4 and HPV-9 cLIAs. Antibody assignments to the HPV-9 reference standard for HPV31/33/45/52/58 were obtained by calibration to HPV11 using a direct binding IgG assay. For each HPV VLP type, the cross-reactivity of the mAb-PEs in the HPV-9 cLIA was
ISSN:2164-5515
2164-554X
DOI:10.4161/hv.29205