Safety and Immunogenicity of H1/IC31®, an Adjuvanted TB Subunit Vaccine, in HIV-Infected Adults with CD4+ Lymphocyte Counts Greater than 350 cells/mm3: A Phase II, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled Trial
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{"title"=>"Safety and immunogenicity of h1/ic31h, an adjuvanted tb subunit vaccine, in hiv-infected adults with cd4+ lymphocyte counts greater than 350 cells/mm3: A phase ii, multi-centre, double-blind, randomized, placebo-controlled trial e114602", "type"=>"journal", "authors"=>[{"first_name"=>"Klaus", "last_name"=>"Reither", "scopus_author_id"=>"6602669662"}, {"first_name"=>"Lynn", "last_name"=>"Katsoulis", "scopus_author_id"=>"55828710500"}, {"first_name"=>"Trevor", "last_name"=>"Beattie", "scopus_author_id"=>"56442179800"}, {"first_name"=>"Nicolene", "last_name"=>"Gardiner", "scopus_author_id"=>"55175309600"}, {"first_name"=>"Nicole", "last_name"=>"Lenz", "scopus_author_id"=>"56442584100"}, {"first_name"=>"Khadija", "last_name"=>"Said", "scopus_author_id"=>"55898214300"}, {"first_name"=>"Elirehema", "last_name"=>"Mfinanga", "scopus_author_id"=>"55155461600"}, {"first_name"=>"Christian", "last_name"=>"Pohl", "scopus_author_id"=>"55920819300"}, {"first_name"=>"Katherine L.", "last_name"=>"Fielding", "scopus_author_id"=>"35493200400"}, {"first_name"=>"Hannah", "last_name"=>"Jeffery", "scopus_author_id"=>"57014824900"}, {"first_name"=>"Benjamin M.", "last_name"=>"Kagina", "scopus_author_id"=>"35733887600"}, {"first_name"=>"Elisabeth J.", "last_name"=>"Hughes", "scopus_author_id"=>"18835810100"}, {"first_name"=>"Thomas J.", "last_name"=>"Scriba", "scopus_author_id"=>"6506142685"}, {"first_name"=>"Willem A.", "last_name"=>"Hanekom", "scopus_author_id"=>"6603950018"}, {"first_name"=>"Søren T.", "last_name"=>"Hoff", "scopus_author_id"=>"16833590100"}, {"first_name"=>"Peter", "last_name"=>"Bang", "scopus_author_id"=>"36852757600"}, {"first_name"=>"Ingrid", "last_name"=>"Kromann", "scopus_author_id"=>"7801460563"}, {"first_name"=>"Claudia", "last_name"=>"Daubenberger", "scopus_author_id"=>"6603959487"}, {"first_name"=>"Peter", "last_name"=>"Andersen", "scopus_author_id"=>"7403262630"}, {"first_name"=>"Gavin J.", "last_name"=>"Churchyard", "scopus_author_id"=>"7004276892"}], "year"=>2014, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-84916631561", "sgr"=>"84916631561", "pui"=>"600717257", "isbn"=>"978-92-95069-34-3", "pmid"=>"25490675", "doi"=>"10.1371/journal.pone.0114602"}, "id"=>"9ef2670b-39f2-38f5-bcb8-3186573ba6e0", "abstract"=>"BACKGROUND: Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1) formulated with the adjuvant IC31, was evaluated in HIV-infected adults.\\n\\nMETHODS: HIV-infected adults with CD4+ T cell counts >350/mm3 and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5:1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.\\n\\nRESULTS: 47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015). Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.\\n\\nCONCLUSION: H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.\\n\\nTRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR) PACTR201105000289276.", "link"=>"http://www.mendeley.com/research/safety-immunogenicity-h1ic31h-adjuvanted-tb-subunit-vaccine-hivinfected-adults-cd4-lymphocyte-counts", "reader_count"=>29, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>9, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>8, "Student > Bachelor"=>2, "Professor"=>2, "Student > Doctoral Student"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Librarian"=>1, "Researcher"=>9, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>8, "Student > Bachelor"=>2, "Professor"=>2, "Student > Doctoral Student"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Biochemistry, Genetics and Molecular Biology"=>3, "Nursing and Health Professions"=>1, "Agricultural and Biological Sciences"=>6, "Medicine and Dentistry"=>9, "Pharmacology, Toxicology and Pharmaceutical Science"=>2, "Social Sciences"=>1, "Computer Science"=>1, "Immunology and Microbiology"=>5}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>9}, "Social Sciences"=>{"Social Sciences"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>5}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>6}, "Computer Science"=>{"Computer Science"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}}, "reader_count_by_country"=>{"Tanzania"=>1}, "group_count"=>2}

Scopus | Further Information

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  • {"files"=>["https://ndownloader.figshare.com/files/1830903", "https://ndownloader.figshare.com/files/1830904"], "description"=>"<div><p>Background</p><p>Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1) formulated with the adjuvant IC31, was evaluated in HIV-infected adults.</p><p>Methods</p><p>HIV-infected adults with CD4+ T cell counts >350/mm<sup>3</sup> and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5∶1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.</p><p>Results</p><p>47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015). Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.</p><p>Conclusion</p><p>H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm<sup>3</sup>. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.</p><p>Trial registration</p><p>Pan African Clinical Trials Registry (PACTR) <a href=\"http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?_nfpb=true&_windowLabel=BasicSearchUpdateController_1&BasicSearchUpdateController_1_actionOverride=%2Fpageflows%2Ftrial%2FbasicSearchUpdate%2FviewTrail&BasicSearchUpdateController_1id=289\" target=\"_blank\">PACTR201105000289276</a></p></div>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265403, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0114602.s001", "https://dx.doi.org/10.1371/journal.pone.0114602.s002"], "stats"=>{"downloads"=>1, "page_views"=>26, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Safety_and_Immunogenicity_of_H1_IC31_an_Adjuvanted_TB_Subunit_Vaccine_in_HIV_Infected_Adults_with_CD4_Lymphocyte_Counts_Greater_than_350_cells_mm_3_A_Phase_II_Multi_Centre_Double_Blind_Randomized_Placebo_Controlled_Trial/1265403", "title"=>"Safety and Immunogenicity of H1/IC31®, an Adjuvanted TB Subunit Vaccine, in HIV-Infected Adults with CD4+ Lymphocyte Counts Greater than 350 cells/mm<sup>3</sup>: A Phase II, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830888"], "description"=>"<p>Footnote: comparison of CD4+ T cell IFN-γ and/or IL-2 and/or TNF-α responses to H1 at day 70 by those QFT positive or negative, p = 0.5.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265388, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g005", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequencies_of_H1_specific_CD4_T_cells_expressing_IFN_947_TNF_945_or_IL_2_at_day_0_14_56_70_and_182_for_vaccination_group_H1_IC31_group_unstimulated_frequencies_have_been_subtracted_for_a_QFT_positive_n_8202_8202_6_and_b_QFT_negative_n_8202_8202_14_/1265388", "title"=>"Frequencies of H1 specific CD4+ T cells expressing IFN-γ, TNF-α or IL-2 at day 0, 14, 56, 70 and 182, for vaccination group H1/IC31 group [unstimulated frequencies have been subtracted] for a) QFT positive n = 6 and b) QFT negative n = 14.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830885"], "description"=>"<p>Footnote: sample size for all measurements at days 0, 14 and 56 was n = 20 and for day 70 and 182 was n = 19.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265385, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g004", "stats"=>{"downloads"=>1, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kinetics_of_IFN_947_TNF_945_IL_2_and_IL_17_expressing_CD4_T_cells_after_stimulation_with_H1_over_a_6_month_period_day_0_8211_182_in_the_H1_IC31_vaccination_group_detected_by_a_short_term_whole_blood_intracellular_cytokine_assay_/1265385", "title"=>"Kinetics of IFN-γ, TNF-α, IL-2 and IL-17 expressing CD4+ T cells after stimulation with H1 over a 6-month period (day 0–182) in the H1/IC31 vaccination group detected by a short-term whole blood intracellular cytokine assay.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830898"], "description"=>"<p>*reported as possibly related.</p><p>Adverse events (AEs) during trial period (day 0–182) by vaccination group.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265397, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.t002", "stats"=>{"downloads"=>4, "page_views"=>15, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Adverse_events_AEs_during_trial_period_day_0_8211_182_by_vaccination_group_/1265397", "title"=>"Adverse events (AEs) during trial period (day 0–182) by vaccination group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830894"], "description"=>"<p>Frequencies of H1 specific CD4+ T cells expressing any combination of IFN-γ, TNF-α and IL-2 at day 0, 14, 56, 70 and 182 in the vaccination group [unstimulated frequencies have been subtracted].</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265393, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g006", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequencies_of_H1_specific_CD4_T_cells_expressing_any_combination_of_IFN_947_TNF_945_and_IL_2_at_day_0_14_56_70_and_182_in_the_vaccination_group_unstimulated_frequencies_have_been_subtracted_/1265393", "title"=>"Frequencies of H1 specific CD4+ T cells expressing any combination of IFN-γ, TNF-α and IL-2 at day 0, 14, 56, 70 and 182 in the vaccination group [unstimulated frequencies have been subtracted].", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830858"], "description"=>"<p>CONSORT diagram of subjects for screening, exclusions, randomisation, vaccination and follow-up in the vaccine trial.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265359, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g001", "stats"=>{"downloads"=>3, "page_views"=>68, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CONSORT_diagram_of_subjects_for_screening_exclusions_randomisation_vaccination_and_follow_up_in_the_vaccine_trial_/1265359", "title"=>"CONSORT diagram of subjects for screening, exclusions, randomisation, vaccination and follow-up in the vaccine trial.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830871"], "description"=>"<p>The plots show sequentially the gating hierarchy of one representative sample: CD3+ T cells, single cells, lymphocytes, time, CD8-T cells, which were further gated for CD4+ cells. The plots on the lowest row include the cytokine expression gates for either unstimulated or H1 fusion protein stimulated PBMC at day 70 divided in the co-expression of IL-17 and IL-2 or TNF-α and IFN-γ by CD4+ T cells.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265373, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g002", "stats"=>{"downloads"=>2, "page_views"=>136, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Gating_strategy_used_for_flow_cytometric_analysis_of_H1_induced_T_cell_cytokine_expression_/1265373", "title"=>"Gating strategy used for flow cytometric analysis of H1-induced T cell cytokine expression.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830900"], "description"=>"<p>QuantiFERON status at baseline and at day 182.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265400, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.t003", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_QuantiFERON_status_at_baseline_and_at_day_182_/1265400", "title"=>"QuantiFERON status at baseline and at day 182.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830895"], "description"=>"<p><sup>*</sup>other groups included Indian, White, Asian or mixed heritage.</p>#<p>based on arithmetic mean of participant data from the two screening visits and day 0.</p>○<p>based on arithmetic mean of participant data from the first screening visit and day 0.</p><p>IQR interquartile range.</p><p>Demographic and baseline characteristics of the study participants by vaccination group.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265395, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.t001", "stats"=>{"downloads"=>1, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographic_and_baseline_characteristics_of_the_study_participants_by_vaccination_group_/1265395", "title"=>"Demographic and baseline characteristics of the study participants by vaccination group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-12-09 02:42:07"}
  • {"files"=>["https://ndownloader.figshare.com/files/1830881"], "description"=>"<p>Kinetics of Ag85B, ESAT-6 and H1 specific CD4+ and CD8+ T cells expressing IFN-γ, TNF-α or IL-2 for day 0 for the placebo arm (P: day 0) and over a 6-month period (day 0–182) in the vaccine (H1/IC31) arm detected by a short-term whole blood intracellular cytokine assay.</p>", "links"=>[], "tags"=>["Adjuvanted TB Subunit Vaccine", "PACTR", "ifn", "48 randomised participants", "blood intracellular cytokine staining assay.Results 47", "vaccine", "il", "Clinical Trials Registry", "56. Safety assessment", "hiv", "85B", "study arm", "count", "Local injection site reactions", "ii", "tnf", "ic"], "article_id"=>1265380, "categories"=>["Biological Sciences"], "users"=>["Klaus Reither", "Lynn Katsoulis", "Trevor Beattie", "Nicolene Gardiner", "Nicole Lenz", "Khadija Said", "Elirehema Mfinanga", "Christian Pohl", "Katherine L. Fielding", "Hannah Jeffery", "Benjamin M. Kagina", "Elisabeth J. Hughes", "Thomas J. Scriba", "Willem A. Hanekom", "Søren T. Hoff", "Peter Bang", "Ingrid Kromann", "Claudia Daubenberger", "Peter Andersen", "Gavin J. Churchyard"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0114602.g003", "stats"=>{"downloads"=>4, "page_views"=>14, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Kinetics_of_Ag85B_ESAT_6_and_H1_specific_CD4_and_CD8_T_cells_expressing_IFN_947_TNF_945_or_IL_2_for_day_0_for_the_placebo_arm_P_day_0_and_over_a_6_month_period_day_0_8211_182_in_the_vaccine_H1_IC31_arm_detected_by_a_short_term_whole_blood_intracellular_c/1265380", "title"=>"Kinetics of Ag85B, ESAT-6 and H1 specific CD4+ and CD8+ T cells expressing IFN-γ, TNF-α or IL-2 for day 0 for the placebo arm (P: day 0) and over a 6-month period (day 0–182) in the vaccine (H1/IC31) arm detected by a short-term whole blood intracellular cytokine assay.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-12-09 02:42:07"}

PMC Usage Stats | Further Information

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