A Randomized, Placebo-Controlled Trial of the Bivalent Killed, Whole-Cell, Oral Cholera Vaccine in Adults and Children in a Cholera Endemic Area in Kolkata, India
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{"title"=>"A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India", "type"=>"journal", "authors"=>[{"first_name"=>"Dilip", "last_name"=>"Mahalanabis", "scopus_author_id"=>"7005004199"}, {"first_name"=>"Anna Lena", "last_name"=>"Lopez", "scopus_author_id"=>"7401455382"}, {"first_name"=>"Dipika", "last_name"=>"Sur", "scopus_author_id"=>"7003718515"}, {"first_name"=>"Jacqueline", "last_name"=>"Deen", "scopus_author_id"=>"7005754743"}, {"first_name"=>"Byomkesh", "last_name"=>"Manna", "scopus_author_id"=>"7004221617"}, {"first_name"=>"Suman", "last_name"=>"Kanungo", "scopus_author_id"=>"14014057700"}, {"first_name"=>"Lorenz", "last_name"=>"von Seidlein", "scopus_author_id"=>"7003391764"}, {"first_name"=>"Rodney", "last_name"=>"Carbis", "scopus_author_id"=>"15729363800"}, {"first_name"=>"Seung Hyun", "last_name"=>"Han", "scopus_author_id"=>"9243903200"}, {"first_name"=>"Seong Hye", "last_name"=>"Shin", "scopus_author_id"=>"24578054500"}, {"first_name"=>"Stephen", "last_name"=>"Attridge", "scopus_author_id"=>"7004589693"}, {"first_name"=>"Raman", "last_name"=>"Rao", "scopus_author_id"=>"8452695900"}, {"first_name"=>"Jan", "last_name"=>"Holmgren", "scopus_author_id"=>"7101945779"}, {"first_name"=>"John", "last_name"=>"Clemens", "scopus_author_id"=>"7202170508"}, {"first_name"=>"Sujit K.", "last_name"=>"Bhattacharya", "scopus_author_id"=>"7404284693"}], "year"=>2008, "source"=>"PLoS ONE", "identifiers"=>{"issn"=>"19326203", "scopus"=>"2-s2.0-48449101248", "sgr"=>"48449101248", "pui"=>"352094526", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"18523643", "doi"=>"10.1371/journal.pone.0002323"}, "id"=>"2f836f5f-96bb-35eb-a005-c64ee677891b", "abstract"=>"OBJECTIVES: An effective vaccine against cholera has been used for public health purposes in Vietnam since the 1990s. This vaccine was reformulated to meet WHO requirements. We assessed the safety and immunogenicity of the reformulated bivalent (Vibrio cholerae 01 and 0139) killed whole cell oral vaccine in a cholera endemic area in Kolkata, India.\\n\\nDESIGN: Double-blind, randomized, placebo controlled trial.\\n\\nSETTING: The trial was conducted in the clinical trial ward of the Infectious Diseases Hospital in Kolkata, India.\\n\\nPARTICIPANTS: The participants were 101 healthy adults (males and non-pregnant females) aged 18-40 years and 100 healthy children (males and non-pregnant females) aged 1-17 years.\\n\\nINTERVENTIONS: Participants were randomized to receive either the bivalent killed whole cell oral cholera vaccine or placebo (killed oral Escherichia coli K12).\\n\\nOUTCOME MEASURES: For safety: proportion of subjects with adverse events during the duration of study participation. For immunogenicity: Proportion of subjects who had a > or = 4-fold rise in serum vibriocidal antibody titers 14 days after the second dose of vaccine or placebo.\\n\\nRESULTS: Adverse reactions were observed with similar frequency among vaccine and placebo recipients in both age groups. Among adults 4% of vaccine and 8% of placebo recipients and among children 4% of vaccine and 2% of placebo recipients had at least one adverse event within 28 days of the first dose of the vaccine. Following immunization, 53% of adult and 80% of children vaccinees showed a > or = 4 fold rise in serum V. cholerae O1 vibriocidal antibody titers. A less pronounced response to V. cholerae O139 vibriocidal antibody titers post-immunization was noted among vaccinees.\\n\\nCONCLUSIONS: We found the vaccine to be safe and immunogenic in a cholera-endemic area in India.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00119197.", "link"=>"http://www.mendeley.com/research/randomized-placebocontrolled-trial-bivalent-killed-wholecell-oral-cholera-vaccine-adults-children-ch", "reader_count"=>48, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>4, "Student > Doctoral Student"=>5, "Researcher"=>13, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>8, "Other"=>4, "Student > Bachelor"=>5, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>4, "Student > Doctoral Student"=>5, "Researcher"=>13, "Student > Ph. D. Student"=>4, "Student > Postgraduate"=>1, "Student > Master"=>8, "Other"=>4, "Student > Bachelor"=>5, "Lecturer > Senior Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Engineering"=>1, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Medicine and Dentistry"=>22, "Agricultural and Biological Sciences"=>8, "Business, Management and Accounting"=>1, "Psychology"=>1, "Social Sciences"=>2, "Immunology and Microbiology"=>2, "Economics, Econometrics and Finance"=>3}, "reader_count_by_subdiscipline"=>{"Engineering"=>{"Engineering"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>22}, "Social Sciences"=>{"Social Sciences"=>2}, "Psychology"=>{"Psychology"=>1}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>3}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>8}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Environmental Science"=>{"Environmental Science"=>1}}, "reader_count_by_country"=>{"Bangladesh"=>1, "United States"=>1, "Ireland"=>1, "Japan"=>1, "Tanzania"=>1, "United Kingdom"=>1, "India"=>1}, "group_count"=>2}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/929610"], "description"=>"<p>Characteristics of adult and children vaccine and placebo recipients</p>", "links"=>[], "tags"=>["children", "placebo"], "article_id"=>600044, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0002323.t001", "stats"=>{"downloads"=>3, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_adult_and_children_vaccine_and_placebo_recipients_/600044", "title"=>"Characteristics of adult and children vaccine and placebo recipients", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-06-04 00:00:44"}
  • {"files"=>["https://ndownloader.figshare.com/files/929717"], "description"=>"a<p>Geometric mean reciprocal titer for the cited bleed</p>b<p>Geometric mean-fold rise between first and second bleed.</p>c<p>Number of subjects with ≥4 fold rise in titers between first and second bleed</p>d<p>Lower boundary of the one-tailed, 95% confidence intervals for the percentage of vaccinees that seroconverted compared to the placebo recipients (shown because the primary hypotheses for the trial included this lower boundary, see text).</p>", "links"=>[], "tags"=>["vibriocidal", "antibody", "titers", "o1", "inaba", "o139", "baseline", "14", "days", "subjects", "paired"], "article_id"=>600135, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0002323.t003", "stats"=>{"downloads"=>1, "page_views"=>10, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Serum_vibriocidal_antibody_titers_to_V_cholerae_O1_Inaba_and_V_cholerae_O139_at_baseline_and_14_days_after_the_second_dose_among_subjects_with_paired_blood_specimens_/600135", "title"=>"Serum vibriocidal antibody titers to <i>V. cholerae</i> O1 Inaba and <i>V. cholerae</i> O139 at baseline and 14 days after the second dose among subjects with paired blood specimens", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-06-04 00:02:15"}
  • {"files"=>["https://ndownloader.figshare.com/files/458396", "https://ndownloader.figshare.com/files/458549"], "description"=>"<div><h3>Objectives</h3><p>An effective vaccine against cholera has been used for public health purposes in Vietnam since the 1990s. This vaccine was reformulated to meet WHO requirements. We assessed the safety and immunogenicity of the reformulated bivalent (<em>Vibrio cholerae</em> 01 and 0139) killed whole cell oral vaccine in a cholera endemic area in Kolkata, India.</p><h3>Design</h3><p>Double-blind, randomized, placebo controlled trial</p><h3>Setting</h3><p>The trial was conducted in the clinical trial ward of the Infectious Diseases Hospital in Kolkata, India</p><h3>Participants</h3><p>The participants were 101 healthy adults (males and non-pregnant females) aged 18–40 years and 100 healthy children (males and non-pregnant females) aged 1–17 years.</p><h3>Interventions</h3><p>Participants were randomized to receive either the bivalent killed whole cell oral cholera vaccine or placebo (killed oral <em>Escherichia coli</em> K12)</p><h3>Outcome Measures</h3><p>For safety: proportion of subjects with adverse events during the duration of study participation. For immunogenicity: Proportion of subjects who had a ≥4-fold rise in serum vibriocidal antibody titers 14 days after the second dose of vaccine or placebo.</p><h3>Results</h3><p>Adverse reactions were observed with similar frequency among vaccine and placebo recipients in both age groups. Among adults 4% of vaccine and 8% of placebo recipients and among children 4% of vaccine and 2% of placebo recipients had at least one adverse event within 28 days of the first dose of the vaccine. Following immunization, 53% of adult and 80% of children vaccinees showed a ≥4 fold rise in serum <em>V. cholerae</em> O1 vibriocidal antibody titers. A less pronounced response to <em>V. cholerae</em> O139 vibriocidal antibody titers post-immunization was noted among vaccinees.</p><h3>Conclusions</h3><p>We found the vaccine to be safe and immunogenic in a cholera-endemic area in India.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://www.clinicaltrials.gov/ct/show/NCT00119197order3\">NCT00119197</a></p></div>", "links"=>[], "tags"=>["placebo-controlled", "bivalent", "cholera", "adults", "children", "endemic", "india"], "article_id"=>150301, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0002323.s001", "https://dx.doi.org/10.1371/journal.pone.0002323.s002"], "stats"=>{"downloads"=>16, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/A_Randomized_Placebo_Controlled_Trial_of_the_Bivalent_Killed_Whole_Cell_Oral_Cholera_Vaccine_in_Adults_and_Children_in_a_Cholera_Endemic_Area_in_Kolkata_India/150301", "title"=>"A Randomized, Placebo-Controlled Trial of the Bivalent Killed, Whole-Cell, Oral Cholera Vaccine in Adults and Children in a Cholera Endemic Area in Kolkata, India", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2008-06-04 00:05:01"}
  • {"files"=>["https://ndownloader.figshare.com/files/929566"], "description"=>"*<p>Titers to V. cholerae O139 were rounded up</p>", "links"=>[], "tags"=>["fold-increase", "serum", "vibriocidal", "antibody", "titers", "o1", "inaba", "o139", "baseline", "14", "days", "post-second", "children"], "article_id"=>599982, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0002323.t004", "stats"=>{"downloads"=>1, "page_views"=>13, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Frequency_table_of_fold_increase_of_serum_vibriocidal_antibody_titers_to_V_cholerae_O1_Inaba_and_O139_from_baseline_and_14_days_post_second_dose_among_adult_and_children_vaccinees_/599982", "title"=>"Frequency table of fold-increase of serum vibriocidal antibody titers to <i>V. cholerae</i> O1 Inaba and O139 from baseline and 14 days post-second dose among adult and children vaccinees", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-06-04 02:46:22"}
  • {"files"=>["https://ndownloader.figshare.com/files/929481"], "description"=>"<p>Flowchart of adult and children participants in the study.</p>", "links"=>[], "tags"=>["children"], "article_id"=>599914, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0002323.g001", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flowchart_of_adult_and_children_participants_in_the_study_/599914", "title"=>"Flowchart of adult and children participants in the study.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2008-06-04 02:45:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/929663"], "description"=>"a<p>Values in brackets represent the upper boundaries for one tailed 95% confidence interval for the differences in the diarrheal adverse events among vaccinees compared to placebo recipients</p>b<p>Values in parenthesis represent the percentage of group total</p>", "links"=>[], "tags"=>["solicited", "adverse", "adults", "children", "receipt", "doses"], "article_id"=>600093, "categories"=>["Medicine", "Cancer"], "users"=>["Dilip Mahalanabis", "Anna Lena Lopez", "Dipika Sur", "Jacqueline Deen", "Byomkesh Manna", "Suman Kanungo", "Lorenz von Seidlein", "Rodney Carbis", "Seung Hyun Han", "Seong Hye Shin", "Stephen Attridge", "Raman Rao", "Jan Holmgren", "John Clemens", "Sujit K. Bhattacharya"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0002323.t002", "stats"=>{"downloads"=>1, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Comparison_of_solicited_adverse_events_among_adults_and_children_following_receipt_of_the_first_and_second_doses_of_vaccine_and_placebo_/600093", "title"=>"Comparison of solicited adverse events among adults and children following receipt of the first and second doses of vaccine and placebo", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2008-06-04 00:01:33"}

PMC Usage Stats | Further Information

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Relative Metric

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