Literature DB >> 16959262

Statistical positivity criteria for the analysis of ELISpot assay data in HIV-1 vaccine trials.

Zoe Moodie1, Yunda Huang, Lin Gu, John Hural, Steven G Self.   

Abstract

The enzyme-linked immunospot (ELISpot) assay is one of the leading technologies used to measure cellular responses in many settings including HIV vaccine clinical trials. HIV-1-specific effector T lymphocyte responses are considered necessary in the control of infection. Accurate measurement and summary of cellular immune responses are critical to HIV research. ELISpot assay readout is often dichotomized into positive/negative responses according to some pre-specified criteria. Given the increase in the number of replicates used for each stimulation with current assay configurations in the HIV Vaccine Trials Network (HVTN) laboratories, a new approach is now possible. We propose an objective criteria based on a hypothesis-driven method that controls the false positive rate while maintaining sensitivity to each of the antigen-specific responses under study. The new approach is compared to other commonly employed criteria using real and simulated data.

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Year:  2006        PMID: 16959262     DOI: 10.1016/j.jim.2006.07.015

Source DB:  PubMed          Journal:  J Immunol Methods        ISSN: 0022-1759            Impact factor:   2.303


  33 in total

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2.  Epitope specific T-cell responses against influenza A in a healthy population.

Authors:  Miloje Savic; Jennifer L Dembinski; Yohan Kim; Gro Tunheim; Rebecca J Cox; Fredrik Oftung; Bjoern Peters; Siri Mjaaland
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3.  Long-term toxicity, pharmacokinetics and immune effects of a recombinant adenovirus vaccine expressing human papillomavirus 16 E6 and E7 proteins (HPV16 E6E7-Ad5 Vac) in primates.

Authors:  Jie Wu; Gang Chen; Fang-Cheng Zhuang; Meng Gao; Chuan-Dong Wu; Zhan-Long He; Yun-Shui Jiang; Jian-Bo Li; Jia-Yuan Bao; Zi-An Mao
Journal:  Am J Transl Res       Date:  2018-05-15       Impact factor: 4.060

4.  Optimal auxiliary-covariate-based two-phase sampling design for semiparametric efficient estimation of a mean or mean difference, with application to clinical trials.

Authors:  Peter B Gilbert; Xuesong Yu; Andrea Rotnitzky
Journal:  Stat Med       Date:  2013-10-09       Impact factor: 2.373

5.  Statistical methods for the assessment of EQAPOL proficiency testing: ELISpot, Luminex, and Flow Cytometry.

Authors:  Wes Rountree; Nathan Vandergrift; John Bainbridge; Ana M Sanchez; Thomas N Denny
Journal:  J Immunol Methods       Date:  2014-01-20       Impact factor: 2.303

6.  Development of an interferon-gamma ELISPOT assay to detect human T cell responses to HSV-2.

Authors:  Christine M Posavad; Amalia S Magaret; Lin Zhao; Dawn E Mueller; Anna Wald; Lawrence Corey
Journal:  Vaccine       Date:  2011-07-27       Impact factor: 3.641

7.  BNT162b2 vaccine induces neutralizing antibodies and poly-specific T cells in humans.

Authors:  Ugur Sahin; Alexander Muik; Isabel Vogler; Evelyna Derhovanessian; Lena M Kranz; Mathias Vormehr; Jasmin Quandt; Nicole Bidmon; Alexander Ulges; Alina Baum; Kristen E Pascal; Daniel Maurus; Sebastian Brachtendorf; Verena Lörks; Julian Sikorski; Peter Koch; Rolf Hilker; Dirk Becker; Ann-Kathrin Eller; Jan Grützner; Manuel Tonigold; Carsten Boesler; Corinna Rosenbaum; Ludwig Heesen; Marie-Cristine Kühnle; Asaf Poran; Jesse Z Dong; Ulrich Luxemburger; Alexandra Kemmer-Brück; David Langer; Martin Bexon; Stefanie Bolte; Tania Palanche; Armin Schultz; Sybille Baumann; Azita J Mahiny; Gábor Boros; Jonas Reinholz; Gábor T Szabó; Katalin Karikó; Pei-Yong Shi; Camila Fontes-Garfias; John L Perez; Mark Cutler; David Cooper; Christos A Kyratsous; Philip R Dormitzer; Kathrin U Jansen; Özlem Türeci
Journal:  Nature       Date:  2021-05-27       Impact factor: 49.962

8.  Safety and immunogenicity of a CTL multiepitope peptide vaccine for HIV with or without GM-CSF in a phase I trial.

Authors:  Paul Spearman; Spyros Kalams; Marnie Elizaga; Barbara Metch; Ya-Lin Chiu; Mary Allen; Kent J Weinhold; Guido Ferrari; Scott D Parker; M Juliana McElrath; Sharon E Frey; Jonathan D Fuchs; Michael C Keefer; Michael D Lubeck; Michael Egan; Ralph Braun; John H Eldridge; Barton F Haynes; Lawrence Corey
Journal:  Vaccine       Date:  2008-11-07       Impact factor: 3.641

9.  Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses.

Authors:  Richard A Koup; Mario Roederer; Laurie Lamoreaux; Jennifer Fischer; Laura Novik; Martha C Nason; Brenda D Larkin; Mary E Enama; Julie E Ledgerwood; Robert T Bailer; John R Mascola; Gary J Nabel; Barney S Graham
Journal:  PLoS One       Date:  2010-02-02       Impact factor: 3.240

10.  Response definition criteria for ELISPOT assays revisited.

Authors:  Z Moodie; L Price; C Gouttefangeas; A Mander; S Janetzki; M Löwer; M J P Welters; C Ottensmeier; S H van der Burg; Cedrik M Britten
Journal:  Cancer Immunol Immunother       Date:  2010-06-15       Impact factor: 6.968

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