International Technology Transfer of a GCLP-Compliant HIV-1 Neutralizing Antibody Assay for Human Clinical Trials
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{"title"=>"International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials", "type"=>"journal", "authors"=>[{"first_name"=>"Daniel A.", "last_name"=>"Ozaki", "scopus_author_id"=>"6602821685"}, {"first_name"=>"Hongmei", "last_name"=>"Gao", "scopus_author_id"=>"36608093600"}, {"first_name"=>"Christopher A.", "last_name"=>"Todd", "scopus_author_id"=>"35199387900"}, {"first_name"=>"Kelli M.", "last_name"=>"Greene", "scopus_author_id"=>"35175871900"}, {"first_name"=>"David C.", "last_name"=>"Montefiori", "scopus_author_id"=>"7005651585"}, {"first_name"=>"Marcella", "last_name"=>"Sarzotti-Kelsoe", "scopus_author_id"=>"7004914316"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-84856398863", "pui"=>"364168025", "doi"=>"10.1371/journal.pone.0030963", "isbn"=>"1932-6203 (Electronic)\\n1932-6203 (Linking)", "sgr"=>"84856398863", "pmid"=>"22303476"}, "id"=>"c98a5ad3-0bad-3042-960f-847b6ae7898a", "abstract"=>"The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.", "link"=>"http://www.mendeley.com/research/international-technology-transfer-gclpcompliant-hiv1-neutralizing-antibody-assay-human-clinical-tria-1", "reader_count"=>24, "reader_count_by_academic_status"=>{"Student > Doctoral Student"=>2, "Researcher"=>6, "Student > Ph. D. Student"=>8, "Other"=>2, "Student > Master"=>5, "Professor"=>1}, "reader_count_by_user_role"=>{"Student > Doctoral Student"=>2, "Researcher"=>6, "Student > Ph. D. Student"=>8, "Other"=>2, "Student > Master"=>5, "Professor"=>1}, "reader_count_by_subject_area"=>{"Engineering"=>1, "Biochemistry, Genetics and Molecular Biology"=>3, "Nursing and Health Professions"=>1, "Agricultural and Biological Sciences"=>6, "Medicine and Dentistry"=>6, "Arts and Humanities"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Chemistry"=>2, "Social Sciences"=>1, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>6}, "Chemistry"=>{"Chemistry"=>2}, "Social Sciences"=>{"Social Sciences"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}, "Arts and Humanities"=>{"Arts and Humanities"=>1}}, "reader_count_by_country"=>{"Portugal"=>1}, "group_count"=>0}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/687371"], "description"=>"<p>The neutralization curve depicts the linear portion of the curve between 20% and 80% neutralization.</p>", "links"=>[], "tags"=>["neutralization"], "article_id"=>357863, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g005", "stats"=>{"downloads"=>3, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Example_of_Neutralization_Curve_/357863", "title"=>"Example of Neutralization Curve.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:27:56"}
  • {"files"=>["https://ndownloader.figshare.com/files/686998"], "description"=>"<p>Briefly, pseudovirus infection of TZM-bl Cells stimulates expression of Luciferase Reporter gene thereby emitting luminescence (A). When the pseudovirus is neutralized prior to the infection of TZM-bl Cells, the Luciferase reporter gene is not expressed and no luminescence is emitted (B).</p>", "links"=>[], "tags"=>["tzm", "bl", "nab"], "article_id"=>357479, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g001", "stats"=>{"downloads"=>3, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Pictorial_representation_of_the_TZM_bl_NAb_Assay_/357479", "title"=>"Pictorial representation of the TZM bl NAb Assay.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:25:54"}
  • {"files"=>["https://ndownloader.figshare.com/files/687530"], "description"=>"<p>Average fold difference between ID<sub>50</sub> values calculated from robustness experiments that varied the number of cells that were used in the assay. Assays were performed using the optimal cell number, twice the optimal cell number, four times the optimal cell number, one-half of the optimal cell number, and one-quarter of the optimal cell number. The ID<sub>50</sub> values for each condition were required to remain within 3-fold of the ID<sub>50</sub> values generated by the optimal cell number.</p>", "links"=>[], "tags"=>["robustness"], "article_id"=>358022, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g007", "stats"=>{"downloads"=>0, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Results_from_robustness_experiments_/358022", "title"=>"Results from robustness experiments.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:28:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/687468"], "description"=>"<p>Laboratories were required to achieve a relative ID<sub>50</sub> value within 3-fold of the mean ID<sub>50</sub> value (established from CRL and all other participating laboratories) for a minimum of 80% of reagent/pseudovirus combinations. Only 7 of the laboratories used the identical batch of competency test kits. The other laboratory used a similar kit from the Proficiency Testing program and was able to achieve the pre-determined pass/fail criteria for the program (data not shown).</p>", "links"=>[], "tags"=>["means", "on-site", "competency"], "article_id"=>357955, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g006", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Average_fold_difference_between_laboratory_values_and_means_during_initial_on_site_competency_testing_/357955", "title"=>"Average fold difference between laboratory values and means during initial on-site competency testing.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:28:25"}
  • {"files"=>["https://ndownloader.figshare.com/files/687160"], "description"=>"<p>The optimal concentration of DEAE-Dextran (x-axis) to use in the TZM-bl NAb Assay is calculated by selecting a concentration lower than the concentration yielding the peak RLU values on both titration curves of two pseudoviruses (in this instance QHO692.42, CAAN5342.A2). By picking the concentration lower than the peak, one avoids potential cell toxicity that may result with the use of other pseudoviruses. The vertical dotted line in the graph represents the concentration of DEAE-Dextran that maximizes the infectivity of the pseudovirus without being toxic to the TZM-bl cells.</p>", "links"=>[], "tags"=>["deae-dextran", "titration"], "article_id"=>357649, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g003", "stats"=>{"downloads"=>1, "page_views"=>48, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Example_of_a_DEAE_Dextran_titration_curve_using_two_pseudoviruses_/357649", "title"=>"Example of a DEAE-Dextran titration curve using two pseudoviruses.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:26:48"}
  • {"files"=>["https://ndownloader.figshare.com/files/687091"], "description"=>"<p>Each month the values of a NIST-traceable-calibrated validation plate are plotted on a graph. The graphs are then superimposed and the values must remain within 10% of the established baseline (mean of the 20 initial runs).</p>", "links"=>[], "tags"=>["luminometer", "validation"], "article_id"=>357583, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g002", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Example_of_a_luminometer_validation_curve_/357583", "title"=>"Example of a luminometer validation curve.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:26:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/687606"], "description"=>"<p>(A) Results show the %CV between the ID<sub>50</sub> values generated by two operators carrying out the identical experiment on the same days. Each point represents one sample/pseudovirus combination. (B) Results show the %CV between ID<sub>50</sub> values generated from identical experiments conducted by the same operator on 3 different days. Each point represents one sample/pseudovirus combination.</p>", "links"=>[], "tags"=>["precision", "inter-operator"], "article_id"=>358094, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g008", "stats"=>{"downloads"=>1, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Results_from_precision_experiments_inter_operator_and_inter_assay_/358094", "title"=>"Results from precision experiments: inter-operator and inter-assay.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:29:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/687708"], "description"=>"<p>CAVD/CA-VIMC Regional Laboratories that completed the Assay Implementation Plan.</p>", "links"=>[], "tags"=>["laboratories", "completed", "assay"], "article_id"=>358195, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.t001", "stats"=>{"downloads"=>3, "page_views"=>36, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CAVD_CA_VIMC_Regional_Laboratories_that_completed_the_Assay_Implementation_Plan_/358195", "title"=>"CAVD/CA-VIMC Regional Laboratories that completed the Assay Implementation Plan.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-20 09:29:43"}
  • {"files"=>["https://ndownloader.figshare.com/files/687261"], "description"=>"<p>The %CV of replicate wells was required to be lower than 10% at least 80% of the time.</p>", "links"=>[], "tags"=>["replicate", "wells", "titrations", "achieved"], "article_id"=>357746, "categories"=>["Science Policy", "Infectious Diseases", "Immunology"], "users"=>["Daniel A. Ozaki", "Hongmei Gao", "Christopher A. Todd", "Kelli M. Greene", "David C. Montefiori", "Marcella Sarzotti-Kelsoe"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0030963.g004", "stats"=>{"downloads"=>0, "page_views"=>20, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Average_CV_of_the_replicate_wells_for_the_virus_titrations_that_achieved_8220_pass_8221_criteria_/357746", "title"=>"Average %CV of the replicate wells for the virus titrations that achieved “pass” criteria.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-20 09:27:18"}

PMC Usage Stats | Further Information

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Relative Metric

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