Immunopotentiation of Trivalent Influenza Vaccine When Given with VAX102, a Recombinant Influenza M2e Vaccine Fused to the TLR5 Ligand Flagellin
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{"title"=>"Immunopotentiation of Trivalent Influenza Vaccine When Given with VAX102, a Recombinant Influenza M2e Vaccine Fused to the TLR5 Ligand Flagellin", "type"=>"journal", "authors"=>[{"first_name"=>"H.", "last_name"=>"Keipp Talbot", "scopus_author_id"=>"35487596500"}, {"first_name"=>"Michael T.", "last_name"=>"Rock", "scopus_author_id"=>"7103386899"}, {"first_name"=>"Casey", "last_name"=>"Johnson", "scopus_author_id"=>"35613206000"}, {"first_name"=>"Lynda", "last_name"=>"Tussey", "scopus_author_id"=>"6603742350"}, {"first_name"=>"Uma", "last_name"=>"Kavita", "scopus_author_id"=>"6507377487"}, {"first_name"=>"Anita", "last_name"=>"Shanker", "scopus_author_id"=>"37085636800"}, {"first_name"=>"Alan R.", "last_name"=>"Shaw", "scopus_author_id"=>"7402249224"}, {"first_name"=>"David N.", "last_name"=>"Taylor", "scopus_author_id"=>"7406867559"}], "year"=>2010, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "pmid"=>"21203437", "pui"=>"361034496", "scopus"=>"2-s2.0-78650827526", "doi"=>"10.1371/journal.pone.0014442", "isbn"=>"1932-6203 (Electronic) 1932-6203 (Linking)", "sgr"=>"78650827526"}, "id"=>"5fe623dd-b5ef-3ab0-ab9b-de0324608239", "abstract"=>"BACKGROUND: Currently controversy exists about the immunogenicity of seasonal trivalent influenza vaccine in certain populations, especially the elderly. STF2.4×M2e (VAX102) is a recombinant fusion protein that links four copies of the ectodomain of influenza virus matrix protein 2 (M2e) antigen to Salmonella typhimurium flagellin, a TLR5 ligand. The objectives of this study were to assess the feasibility of giving VAX102 and TIV in combination in an effort to achieve greater immunogenicity and to provide cross-protection.\\n\\nMETHODOLOGY/PRINCIPAL FINDINGS: Eighty healthy subjects, 18-49 years old, were enrolled in May and June 2009 in a double-blind, randomized, controlled trial at two clinical sites. Subjects were randomized to receive either TIV + VAX102 or TIV + placebo. Both arms tolerated the vaccines. Pain at the injection site was more severe with TIV + VAX102. Two weeks after immunization the HAI responses to the H1 and H3 antigens of TIV were higher in those that received TIV + VAX102 than in TIV + placebo (309 vs 200 and 269 vs 185, respectively), although statistically non-significant. There was no difference in the HAI of the B antigen. In the TIV + VAX102 arm, the geometric mean M2e antibody concentration was 0.5 µg/ml and 73% seroconverted.\\n\\nCONCLUSIONS/SIGNIFICANCE: The combination of TIV + VAX102 has the potential to increase the immune response to the influenza A components of TIV and to provide M2e immunity which may protect against influenza A strains not contained in seasonal TIV.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00921973.", "link"=>"http://www.mendeley.com/research/immunopotentiation-trivalent-influenza-vaccine-given-vax102-recombinant-influenza-m2e-vaccine-fused", "reader_count"=>36, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>1, "Researcher"=>11, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>4, "Other"=>2, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>3}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>1, "Researcher"=>11, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>4, "Other"=>2, "Student > Bachelor"=>3, "Lecturer > Senior Lecturer"=>3}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Biochemistry, Genetics and Molecular Biology"=>5, "Nursing and Health Professions"=>1, "Materials Science"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>11, "Agricultural and Biological Sciences"=>10, "Psychology"=>2, "Immunology and Microbiology"=>4}, "reader_count_by_subdiscipline"=>{"Materials Science"=>{"Materials Science"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>11}, "Psychology"=>{"Psychology"=>2}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>4}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>10}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>5}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>1}}, "reader_count_by_country"=>{"Sweden"=>1, "United States"=>2, "India"=>1}, "group_count"=>3}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/404059", "https://ndownloader.figshare.com/files/404111"], "description"=>"<div><h3>Background</h3><p>Currently controversy exists about the immunogenicity of seasonal trivalent influenza vaccine in certain populations, especially the elderly. STF2.4×M2e (VAX102) is a recombinant fusion protein that links four copies of the ectodomain of influenza virus matrix protein 2 (M2e) antigen to <em>Salmonella typhimurium</em> flagellin, a TLR5 ligand. The objectives of this study were to assess the feasibility of giving VAX102 and TIV in combination in an effort to achieve greater immunogenicity and to provide cross-protection.</p><h3>Methodology/Principal Findings</h3><p>Eighty healthy subjects, 18-49 years old, were enrolled in May and June 2009 in a double-blind, randomized, controlled trial at two clinical sites. Subjects were randomized to receive either TIV + VAX102 or TIV + placebo. Both arms tolerated the vaccines. Pain at the injection site was more severe with TIV + VAX102. Two weeks after immunization the HAI responses to the H1 and H3 antigens of TIV were higher in those that received TIV + VAX102 than in TIV + placebo (309 vs 200 and 269 vs 185, respectively), although statistically non-significant. There was no difference in the HAI of the B antigen. In the TIV + VAX102 arm, the geometric mean M2e antibody concentration was 0.5 µg/ml and 73% seroconverted.</p><h3>Conclusions/Significance</h3><p>The combination of TIV + VAX102 has the potential to increase the immune response to the influenza A components of TIV and to provide M2e immunity which may protect against influenza A strains not contained in seasonal TIV.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://clinicaltrials.gov/show/NCT00921973\">NCT00921973</a></p></div>", "links"=>[], "tags"=>["immunopotentiation", "trivalent", "influenza", "recombinant", "m2e", "fused", "tlr5", "ligand", "flagellin"], "article_id"=>139844, "categories"=>["Cancer", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0014442.s001", "https://dx.doi.org/10.1371/journal.pone.0014442.s002"], "stats"=>{"downloads"=>28, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Immunopotentiation_of_Trivalent_Influenza_Vaccine_When_Given_with_VAX102_a_Recombinant_Influenza_M2e_Vaccine_Fused_to_the_TLR5_Ligand_Flagellin/139844", "title"=>"Immunopotentiation of Trivalent Influenza Vaccine When Given with VAX102, a Recombinant Influenza M2e Vaccine Fused to the TLR5 Ligand Flagellin", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-12-28 02:44:04"}
  • {"files"=>["https://ndownloader.figshare.com/files/809993"], "description"=>"<p>*For Day 28 values N = 36.</p><p>**For Day 28 values N = 39.</p>†<p>Seroconversion to M2e was defined as a serum IgG anti-M2e antibody value ≥0.174 µg/ml and a four-fold rise in titer.</p>", "links"=>[], "tags"=>["antibody", "m2e", "flagellin", "crp"], "article_id"=>480359, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t005", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Geometric_Mean_Concentration_GMC_Antibody_Response_to_M2e_and_flagellin_and_CRP_response_after_one_dose_of_VAX102_/480359", "title"=>"Geometric Mean Concentration (GMC) Antibody Response to M2e and flagellin and CRP response after one dose of VAX102.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:05:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/809955"], "description"=>"<p>GMT  =  Geometric Mean Titer.</p>", "links"=>[], "tags"=>["geometric", "immunologic", "responses", "subjects", "received", "tiv", "co-administered", "placebo", "vax102", "injection", "anatomical"], "article_id"=>480303, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t002", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_HAI_Geometric_Mean_Immunologic_Responses_among_subjects_who_received_one_dose_of_TIV_co_administered_with_placebo_or_VAX102_as_a_separate_injection_at_the_same_anatomical_location_/480303", "title"=>"HAI Geometric Mean Immunologic Responses among subjects who received one dose of TIV co-administered with placebo or VAX102 as a separate injection at the same anatomical location.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:05:03"}
  • {"files"=>["https://ndownloader.figshare.com/files/810042"], "description"=>"<p>Seroprotection is post-vaccination HAI titer of ≥1∶40.</p><p>Seroresponse is either an initial HAI <10 and a post vaccination titer ≥40 or an initial titer ≥10 and a 4-fold or greater increase in titer compared to baseline.</p>", "links"=>[], "tags"=>["seroresponse", "rates", "subjects", "received", "tiv", "co-administered", "placebo", "vax102", "injection", "anatomical"], "article_id"=>480401, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t004", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Seroprotection_SP_and_seroresponse_SR_rates_among_subjects_who_received_one_dose_of_TIV_co_administered_with_placebo_or_VAX102_as_a_separate_injection_at_the_same_anatomical_location_/480401", "title"=>"Seroprotection (SP) and seroresponse (SR) rates among subjects who received one dose of TIV co-administered with placebo or VAX102 as a separate injection at the same anatomical location.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:06:41"}
  • {"files"=>["https://ndownloader.figshare.com/files/809853"], "description"=>"<p>Baseline characteristics of the study subjects according to study arm comparing standard trivalent influenza vaccine and placebo to TIV and VAX102 (STF2.4×M2e).</p>", "links"=>[], "tags"=>["characteristics", "subjects", "comparing", "trivalent", "influenza", "placebo", "tiv", "vax102"], "article_id"=>480210, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t001", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_characteristics_of_the_study_subjects_according_to_study_arm_comparing_standard_trivalent_influenza_vaccine_and_placebo_to_TIV_and_VAX102_STF2_4_215_M2e_/480210", "title"=>"Baseline characteristics of the study subjects according to study arm comparing standard trivalent influenza vaccine and placebo to TIV and VAX102 (STF2.4×M2e).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:03:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/810088"], "description"=>"<p>Solicited local and systemic reactogenicity within 7 days of either trivalent influenza vaccine (TIV) and placebo or TIV and VAX102 given in the same arm.</p>", "links"=>[], "tags"=>["systemic", "reactogenicity", "days", "trivalent", "influenza", "placebo", "tiv", "vax102"], "article_id"=>480441, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t006", "stats"=>{"downloads"=>1, "page_views"=>19, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Solicited_local_and_systemic_reactogenicity_within_7_days_of_either_trivalent_influenza_vaccine_TIV_and_placebo_or_TIV_and_VAX102_given_in_the_same_arm_/480441", "title"=>"Solicited local and systemic reactogenicity within 7 days of either trivalent influenza vaccine (TIV) and placebo or TIV and VAX102 given in the same arm.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:07:21"}
  • {"files"=>["https://ndownloader.figshare.com/files/809787"], "description"=>"<p>Comparison of Geometric Mean HAI Titers among subjects who received TIV +placebo or TIV plus VAX102.</p>", "links"=>[], "tags"=>["geometric", "hai", "titers", "subjects", "received", "tiv"], "article_id"=>480143, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.g001", "stats"=>{"downloads"=>1, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_Geometric_Mean_HAI_Titers_among_subjects_who_received_TIV_placebo_or_TIV_plus_VAX102_/480143", "title"=>"Comparison of Geometric Mean HAI Titers among subjects who received TIV +placebo or TIV plus VAX102.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-12-28 00:02:23"}
  • {"files"=>["https://ndownloader.figshare.com/files/809908"], "description"=>"<p>CRP and HAI Geometric Mean Immunologic Responses among subjects who received one dose of TIV co-administered with placebo or VAX102 as a separate injection at the same anatomical location, stratified by gender for each study arm.</p>", "links"=>[], "tags"=>["hai", "geometric", "immunologic", "responses", "subjects", "received", "tiv", "co-administered", "placebo", "vax102", "injection", "anatomical", "stratified"], "article_id"=>480254, "categories"=>["Infectious Diseases", "Immunology"], "users"=>["H. Keipp Talbot", "Michael T. Rock", "Casey Johnson", "Lynda Tussey", "Uma Kavita", "Anita Shanker", "Alan R. Shaw", "David N. Taylor"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0014442.t003", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_CRP_and_HAI_Geometric_Mean_Immunologic_Responses_among_subjects_who_received_one_dose_of_TIV_co_administered_with_placebo_or_VAX102_as_a_separate_injection_at_the_same_anatomical_location_stratified_by_gender_for_each_study_arm_/480254", "title"=>"CRP and HAI Geometric Mean Immunologic Responses among subjects who received one dose of TIV co-administered with placebo or VAX102 as a separate injection at the same anatomical location, stratified by gender for each study arm.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-12-28 00:04:14"}

PMC Usage Stats | Further Information

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