Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda
Publication Date
December 02, 2008
Journal
PLOS Neglected Tropical Diseases
Authors
Philippe J. Guerin, Lisbeth M. Næss, Carole Fogg, Einar Rosenqvist, et al
Volume
2
Issue
12
Pages
e342
DOI
https://dx.plos.org/10.1371/journal.pntd.0000342
Publisher URL
http://journals.plos.org/plosntds/article?id=10.1371%2Fjournal.pntd.0000342
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/19048025
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2584372
Europe PMC
http://europepmc.org/abstract/MED/19048025
Web of Science
000263301000005
Scopus
65549083873
Mendeley
http://www.mendeley.com/research/immunogenicity-fractional-doses-tetravalent-acyw135-meningococcal-polysaccharide-vaccine-results-ran
Events
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Mendeley | Further Information

{"title"=>"Immunogenicity of fractional doses of tetravalent A/C/Y/W135 meningococcal polysaccharide vaccine: Results from a randomized non-inferiority controlled trial in Uganda", "type"=>"journal", "authors"=>[{"first_name"=>"Philippe J.", "last_name"=>"Guerin", "scopus_author_id"=>"7102745903"}, {"first_name"=>"Lisbeth M.", "last_name"=>"Næss", "scopus_author_id"=>"6701496023"}, {"first_name"=>"Carole", "last_name"=>"Fogg", "scopus_author_id"=>"8418182000"}, {"first_name"=>"Einar", "last_name"=>"Rosenqvist", "scopus_author_id"=>"7003621953"}, {"first_name"=>"Loretxu", "last_name"=>"Pinoges", "scopus_author_id"=>"12795176700"}, {"first_name"=>"Francis", "last_name"=>"Bajunirwe", "scopus_author_id"=>"7801410631"}, {"first_name"=>"Carolyn", "last_name"=>"Nabasumba", "scopus_author_id"=>"23019444800"}, {"first_name"=>"Ray", "last_name"=>"Borrow", "scopus_author_id"=>"7005410023"}, {"first_name"=>"Leif O.", "last_name"=>"Frøholm", "scopus_author_id"=>"7006083306"}, {"first_name"=>"Salah", "last_name"=>"Ghabri", "scopus_author_id"=>"12766012500"}, {"first_name"=>"Vincent", "last_name"=>"Batwala", "scopus_author_id"=>"13004809200"}, {"first_name"=>"Rogers", "last_name"=>"Twesigye", "scopus_author_id"=>"14632608200"}, {"first_name"=>"Ingeborg S.", "last_name"=>"Aaberge", "scopus_author_id"=>"56664206300"}, {"first_name"=>"John Arne", "last_name"=>"Røttingen", "scopus_author_id"=>"7003529676"}, {"first_name"=>"Patrice", "last_name"=>"Piola", "scopus_author_id"=>"6602332229"}, {"first_name"=>"Dominique A.", "last_name"=>"Caugant", "scopus_author_id"=>"7004469951"}], "year"=>2008, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"scopus"=>"2-s2.0-65549083873", "pmid"=>"19048025", "sgr"=>"65549083873", "doi"=>"10.1371/journal.pntd.0000342", "isbn"=>"1935-2735 (Electronic)\\r1935-2727 (Linking)", "issn"=>"1935-2735", "pui"=>"354579401"}, "id"=>"d18b346b-99ee-3698-a3eb-827e7f0662d0", "abstract"=>"Background: Neisseria meningitidis serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine. Methods and Findings: We conducted a randomized, non-inferiority trial in 750 healthy volunteers 219 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10). Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA) with baby rabbit complement. A responder was defined as a subject with a 4-fold increase in SBA against a target strain from each serogroup and SBA titer 128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies. Conclusions: While the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire Meningitis Belt target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa, the use of 1/5 fractional doses should be considered as an alternative in mass vaccination campaigns. Trial Registration: ClinicalTrials.gov NCT00271479", "link"=>"http://www.mendeley.com/research/immunogenicity-fractional-doses-tetravalent-acyw135-meningococcal-polysaccharide-vaccine-results-ran", "reader_count"=>24, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>8, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Other"=>1, "Student > Master"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Professor > Associate Professor"=>2, "Researcher"=>8, "Student > Ph. D. Student"=>6, "Student > Postgraduate"=>1, "Other"=>1, "Student > Master"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Mathematics"=>2, "Agricultural and Biological Sciences"=>4, "Medicine and Dentistry"=>14, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Mathematics"=>{"Mathematics"=>2}, "Unspecified"=>{"Unspecified"=>2}}, "reader_count_by_country"=>{"United Kingdom"=>1}, "group_count"=>2}

Scopus | Further Information

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  • {"month"=>"12", "year"=>"2018", "pdf_views"=>"2", "xml_views"=>"0", "html_views"=>"5"}
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  • {"month"=>"5", "year"=>"2019", "pdf_views"=>"3", "xml_views"=>"0", "html_views"=>"2"}
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  • {"month"=>"12", "year"=>"2019", "pdf_views"=>"3", "xml_views"=>"0", "html_views"=>"4"}

Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/914741"], "description"=>"<p>Distribution of adverse events following vaccination</p>", "links"=>[], "tags"=>["adverse", "events"], "article_id"=>585186, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t006", "stats"=>{"downloads"=>3, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Distribution_of_adverse_events_following_vaccination_/585186", "title"=>"Distribution of adverse events following vaccination", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:26:26"}
  • {"files"=>["https://ndownloader.figshare.com/files/914840"], "description"=>"<p>Proportion of responders per serogroup and per population and SBA GMT at 4 weeks after vaccination</p>", "links"=>[], "tags"=>["responders", "serogroup", "sba", "gmt", "weeks"], "article_id"=>585279, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t003", "stats"=>{"downloads"=>0, "page_views"=>7, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Proportion_of_responders_per_serogroup_and_per_population_and_SBA_GMT_at_4_weeks_after_vaccination_/585279", "title"=>"Proportion of responders per serogroup and per population and SBA GMT at 4 weeks after vaccination", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:27:59"}
  • {"files"=>["https://ndownloader.figshare.com/files/914697"], "description"=>"<p>Non-inferiority analysis results of SBA responders per serogroup and analyses</p>", "links"=>[], "tags"=>["sba", "responders", "serogroup"], "article_id"=>585133, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t004", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Non_inferiority_analysis_results_of_SBA_responders_per_serogroup_and_analyses_/585133", "title"=>"Non-inferiority analysis results of SBA responders per serogroup and analyses", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:25:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/914794"], "description"=>"*<p>One patient randomized in the 1/5-dose group received 1/10 of the dose.</p><p>GSD: Geometric Standard Deviation.</p>", "links"=>[], "tags"=>["serological", "baseline"], "article_id"=>585229, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t001", "stats"=>{"downloads"=>2, "page_views"=>4, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographic_and_serological_baseline_characteristics_/585229", "title"=>"Demographic and serological baseline characteristics", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:27:09"}
  • {"files"=>["https://ndownloader.figshare.com/files/914887"], "description"=>"*<p>Allocated to the wrong age group.</p>**<p>Volunteers presenting a carriage of W135 between the vaccination and four weeks later.</p>", "links"=>[], "tags"=>["exclusions", "randomized"], "article_id"=>585329, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t002", "stats"=>{"downloads"=>6, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Description_of_individual_exclusions_by_population_MITT_PP_Safety_population_and_randomized_group_/585329", "title"=>"Description of individual exclusions by population (MITT, PP, Safety population) and randomized group", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:28:49"}
  • {"files"=>["https://ndownloader.figshare.com/files/914582"], "description"=>"<p>GMC = geometric mean concentration. <i>P</i><0.001 for all comparisons between the vaccination and four weeks later for all serogroups.</p>", "links"=>[], "tags"=>["igg", "concentrations", "serogroup", "vaccination", "weeks", "mitt"], "article_id"=>585017, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.g002", "stats"=>{"downloads"=>1, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_ELISA_IgG_concentrations_per_serogroup_and_per_arm_before_the_vaccination_and_four_weeks_later_in_the_MITT_population_GMC_with_superior_limit_of_95_CI_/585017", "title"=>"ELISA IgG concentrations per serogroup and per arm before the vaccination and four weeks later in the MITT population (GMC with superior limit of 95%CI).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-12-02 01:23:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/914485"], "description"=>"<p>Consort flowchart.</p>", "links"=>[], "tags"=>["immunology/immune response", "immunology/immunity to infections", "infectious diseases/bacterial infections", "infectious diseases/infectious diseases of the nervous system", "infectious diseases/neglected tropical diseases", "infectious diseases/tropical and travel-associated diseases", "neurological disorders/infectious diseases of the nervous system", "pediatrics and child health", "public health and epidemiology/immunization", "public health and epidemiology/infectious diseases"], "article_id"=>584911, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.g001", "stats"=>{"downloads"=>1, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Consort_flowchart_/584911", "title"=>"Consort flowchart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-12-02 01:21:51"}
  • {"files"=>["https://ndownloader.figshare.com/files/452278", "https://ndownloader.figshare.com/files/452297", "https://ndownloader.figshare.com/files/452332"], "description"=>"<div><h3>Background</h3><p><em>Neisseria meningitidis</em> serogroup A is the main causative pathogen of meningitis epidemics in sub-Saharan Africa. In recent years, serogroup W135 has also been the cause of epidemics. Mass vaccination campaigns with polysaccharide vaccines are key elements in controlling these epidemics. Facing global vaccine shortage, we explored the use of fractional doses of a licensed A/C/Y/W135 polysaccharide meningococcal vaccine.</p><h3>Methods and Findings</h3><p>We conducted a randomized, non-inferiority trial in 750 healthy volunteers 2–19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or 1/10). Safety and tolerability data were collected for all subjects during the 4 weeks following the injection. Pre- and post-vaccination sera were analyzed by measuring serum bactericidal activity (SBA) with baby rabbit complement. A responder was defined as a subject with a ≥4-fold increase in SBA against a target strain from each serogroup and SBA titer ≥128. For serogroup W135, 94% and 97% of the vaccinees in the 1/5- and 1/10-dose arms, respectively, were responders, versus 94% in the full-dose arm; for serogroup A, 92% and 88% were responders, respectively, versus 95%. Non-inferiority was demonstrated between the full dose and both fractional doses in SBA seroresponse against serogroups W135 and Y, in total population analysis. Non-inferiority was shown between the full and 1/5 doses for serogroup A in the population non-immune prior to vaccination. Non-inferiority was not shown for any of the fractionate doses for serogroup C. Safety and tolerability data were favourable, as observed in other studies.</p><h3>Conclusions</h3><p>While the advent of conjugate A vaccine is anticipated to largely contribute to control serogroup A outbreaks in Africa, the scale-up of its production will not cover the entire “Meningitis Belt” target population for at least the next 3 to 5 years. In view of the current shortage of meningococcal vaccines for Africa, the use of 1/5 fractional doses should be considered as an alternative in mass vaccination campaigns.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct2/show/NCT00271479?term=NCT00271479&rank=1\">NCT00271479</a></p></div>", "links"=>[], "tags"=>["immunogenicity", "fractional", "doses", "tetravalent", "meningococcal", "polysaccharide", "results", "randomized", "non-inferiority", "controlled", "uganda"], "article_id"=>149084, "categories"=>["Immunology", "Biological Sciences", "Medicine", "Cancer", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0000342.s001", "https://dx.doi.org/10.1371/journal.pntd.0000342.s002", "https://dx.doi.org/10.1371/journal.pntd.0000342.s003"], "stats"=>{"downloads"=>9, "page_views"=>9, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Immunogenicity_of_Fractional_Doses_of_Tetravalent_A_C_Y_W135_Meningococcal_Polysaccharide_Vaccine_Results_from_a_Randomized_Non_Inferiority_Controlled_Trial_in_Uganda/149084", "title"=>"Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2008-12-02 02:31:24"}
  • {"files"=>["https://ndownloader.figshare.com/files/914651"], "description"=>"<p>Logistic regression results of age effect on responder per serogroup and per arm–MITT population</p>", "links"=>[], "tags"=>["regression", "responder", "serogroup"], "article_id"=>585087, "categories"=>["Immunology", "Computational Biology", "Medicine", "Infectious Diseases", "Neuroscience"], "users"=>["Philippe J. Guerin", "Lisbeth M. Næss", "Carole Fogg", "Einar Rosenqvist", "Loretxu Pinoges", "Francis Bajunirwe", "Carolyn Nabasumba", "Ray Borrow", "Leif O. Frøholm", "Salah Ghabri", "Vincent Batwala", "Rogers Twesigye", "Ingeborg S. Aaberge", "John-Arne Røttingen", "Patrice Piola", "Dominique A. Caugant"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0000342.t005", "stats"=>{"downloads"=>1, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Logistic_regression_results_of_age_effect_on_responder_per_serogroup_and_per_arm_8211_MITT_population_/585087", "title"=>"Logistic regression results of age effect on responder per serogroup and per arm–MITT population", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-12-02 01:24:47"}

PMC Usage Stats | Further Information

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Relative Metric

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