Safety and Immunogenicity of Neonatal Pneumococcal Conjugate Vaccination in Papua New Guinean Children: A Randomised Controlled Trial
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Mendeley | Further Information

{"title"=>"Safety and Immunogenicity of Neonatal Pneumococcal Conjugate Vaccination in Papua New Guinean Children: A Randomised Controlled Trial", "type"=>"journal", "authors"=>[{"first_name"=>"William S.", "last_name"=>"Pomat"}, {"first_name"=>"Anita H. J.", "last_name"=>"van den Biggelaar"}, {"first_name"=>"Suparat", "last_name"=>"Phuanukoonnon"}, {"first_name"=>"Jacinta", "last_name"=>"Francis"}, {"first_name"=>"Peter", "last_name"=>"Jacoby"}, {"first_name"=>"Peter M.", "last_name"=>"Siba"}, {"first_name"=>"Michael P.", "last_name"=>"Alpers"}, {"first_name"=>"John C.", "last_name"=>"Reeder"}, {"first_name"=>"Patrick G.", "last_name"=>"Holt"}, {"first_name"=>"Peter C.", "last_name"=>"Richmond"}, {"first_name"=>"Deborah", "last_name"=>"Lehmann"}], "year"=>2013, "source"=>"PLoS ONE", "identifiers"=>{"doi"=>"10.1371/journal.pone.0056698", "issn"=>"1932-6203", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "pmid"=>"23451070"}, "id"=>"38c3a27c-df42-32ed-8c6e-86b0137c471a", "abstract"=>"BACKGROUND: Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.\\n\\nMETHODS: We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.\\n\\nRESULTS: We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.\\n\\nCONCLUSIONS: PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.\\n\\nTRIAL REGISTRATION: ClinicalTrials.gov NCT00219401.", "link"=>"http://www.mendeley.com/research/safety-immunogenicity-neonatal-pneumococcal-conjugate-vaccination-papua-new-guinean-children-randomi-1", "reader_count"=>22, "reader_count_by_academic_status"=>{"Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>3, "Student > Master"=>5, "Other"=>3, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_user_role"=>{"Researcher"=>6, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>3, "Student > Master"=>5, "Other"=>3, "Student > Bachelor"=>2, "Lecturer"=>1, "Professor"=>1}, "reader_count_by_subject_area"=>{"Nursing and Health Professions"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>12, "Agricultural and Biological Sciences"=>4, "Immunology and Microbiology"=>3, "Economics, Econometrics and Finance"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>12}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>3}, "Economics, Econometrics and Finance"=>{"Economics, Econometrics and Finance"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Mathematics"=>{"Mathematics"=>1}}, "reader_count_by_country"=>{"Kenya"=>1}, "group_count"=>1}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/968622"], "description"=>"<p>Flow diagram indicating number of women who assented and children enrolled into the study, randomized to neonatal or infant PCV7 or control groups and number excluded or lost to follow-up in the course of the study. PCV = 7-valent pneumococcal conjugate vaccine; N = Neonatal group; I = Infant group; C = control group; LTFU = lost to follow-up (includes not located, withdrew consent, migration). Numbers (n) are total excluding LTFU and protocol violations.</p>", "links"=>[], "tags"=>["diagram"], "article_id"=>638152, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_diagram_of_the_study_31_/638152", "title"=>"Flow diagram of the study [<b>31</b>].", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-23 10:50:37"}
  • {"files"=>["https://ndownloader.figshare.com/files/968627"], "description"=>"<p>Gender-adjusted incidence rates of hospitalization (±95% confidence intervals) during the 1<sup>st</sup> month, 1–<4 months (PCV immunization ongoing), 4–<10 months (PCV immunization completed), and 10–18 months (post-PPV) of life for the neonatal PCV (green bars), infant PCV (red bars) and control group (blue bars).</p>", "links"=>[], "tags"=>["immunology", "Infectious diseases", "public health and epidemiology", "physiology", "pharmacology", "pediatrics and child health"], "article_id"=>638156, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Risk_for_hospitalization_/638156", "title"=>"Risk for hospitalization.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-23 10:51:06"}
  • {"files"=>["https://ndownloader.figshare.com/files/968628"], "description"=>"<p>Geometric mean (GM) concentrations and 95% confidence intervals of serotype-specific IgG antibodies for PCV7 serotypes and non-PCV7 serotypes 2, 5 and 7F in the neonatal (•) (PCV7 at birth, 1 and 2 months), infant (□) (PCV7 at 1, 2, and 3 months) and control group (▵) (no PCV7). All children received PPV at 9 months of age.</p>", "links"=>[], "tags"=>["geometric", "serotype-specific", "antibody", "concentrations", "pre-and", "post-pcv7", "0-1-2", "1-2-3-months"], "article_id"=>638157, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Age_specific_geometric_mean_serotype_specific_antibody_concentrations_pre_and_post_PCV7_at_0_1_2_or_1_2_3_months_or_no_PCV7_/638157", "title"=>"Age-specific geometric mean serotype-specific antibody concentrations pre-and post-PCV7 at 0-1-2 or 1-2-3-months or no PCV7.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-23 10:51:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/968630"], "description"=>"<p>To demonstrate immunological memory, PPV was administered at 9 months of age and the mean (and 95% CI) fold changes in PCV7-serotype-specific GMCs were calculated and compared for the neonatal (•), infant (□) and control group (▴), with significant differences between groups (p<0.05) indicated with *.</p>", "links"=>[], "tags"=>["antibody", "pcv7-serotypes", "ppv"], "article_id"=>638158, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.g004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Geometric_mean_fold_rise_in_antibody_for_PCV7_serotypes_following_PPV_at_age_9_months_/638158", "title"=>"Geometric mean fold rise in antibody for PCV7-serotypes following PPV at age 9 months.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-02-23 10:51:53"}
  • {"files"=>["https://ndownloader.figshare.com/files/968633", "https://ndownloader.figshare.com/files/968635", "https://ndownloader.figshare.com/files/968636", "https://ndownloader.figshare.com/files/968639", "https://ndownloader.figshare.com/files/968644", "https://ndownloader.figshare.com/files/968649", "https://ndownloader.figshare.com/files/968652", "https://ndownloader.figshare.com/files/968674"], "description"=>"<div><p>Background</p><p>Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.</p> <p>Methods</p><p>We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.</p> <p>Results</p><p>We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.</p> <p>Conclusions</p><p>PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.</p> <p>Trial Registration</p><p>ClinicalTrials.gov <a href=\"http://clinicaltrials.gov/ct2/show/NCT00219401\" target=\"_blank\">NCT00219401</a>NCT00219401</p> </div>", "links"=>[], "tags"=>["immunogenicity", "neonatal", "pneumococcal", "conjugate", "vaccination", "papua", "guinean", "randomised", "controlled", "trial"], "article_id"=>638160, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.s001", "https://dx.doi.org/10.1371/journal.pone.0056698.s002", "https://dx.doi.org/10.1371/journal.pone.0056698.s003", "https://dx.doi.org/10.1371/journal.pone.0056698.s004", "https://dx.doi.org/10.1371/journal.pone.0056698.s005", "https://dx.doi.org/10.1371/journal.pone.0056698.s006", "https://dx.doi.org/10.1371/journal.pone.0056698.s007", "https://dx.doi.org/10.1371/journal.pone.0056698.s008"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Safety_and_Immunogenicity_of_Neonatal_Pneumococcal_Conjugate_Vaccination_in_Papua_New_Guinean_Children_A_Randomised_Controlled_Trial__/638160", "title"=>"Safety and Immunogenicity of Neonatal Pneumococcal Conjugate Vaccination in Papua New Guinean Children: A Randomised Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2013-02-23 10:52:24"}
  • {"files"=>["https://ndownloader.figshare.com/files/1005246"], "description"=>"a<p>Number of assays performed.</p>b<p>Number of assays performed for serotype 5: birth 34–42, 2 months 85–89, 3 months 76–84, 4 months 81–84, 9 months 56–58, 10 months 49–57, 18 months 46–60.</p>", "links"=>[], "tags"=>["samples", "tested", "serotype-specific", "antibody", "titre", "neonatal", "pcv7", "groups"], "article_id"=>665860, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Number_of_samples_tested_and_percentage_with_serotype_specific_antibody_titre_8805_0_35_181_g_ml_95_CI_by_age_in_neonatal_and_infant_PCV7_groups_and_controls_/665860", "title"=>"Number of samples tested and percentage with serotype-specific antibody titre ≥0.35 µg/ml (95% CI) by age in neonatal and infant PCV7 groups and controls.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-22 01:37:40"}
  • {"files"=>["https://ndownloader.figshare.com/files/1005270"], "description"=>"<p>Continuous variables are expressed as mean with standard deviation. Missing data resulted in varying denominators for the following variables: age mother, neonatal, n = 100; infant, n = 103; control, n = 108; smoking pregnancy, neonatal, n = 95; infant, n = 93; control, n = 102; tetanus vaccination, neonatal, n = 89; infant, n = 87; control, n = 94; foetal distress, neonatal, n = 89; infant, n = 85; control, n = 94; delivery, neonatal, n = 100; infant, n = 98; control, n = 107; gestational age, neonatal, n = 103; infant, n = 101; control, n = 102; birth weight, neonatal, n = 103; infant, n = 101; control, n = 102; birth length, neonatal, n = 98; infant, n = 97; control, n = 98; head circumference, neonatal, n = 102; infant, n = 94; control, n = 97; maternal haemoglobin, neonatal, n = 91; infant, n = 87; control, n = 83.</p>", "links"=>[], "tags"=>["newborn", "randomization", "neonatal", "pcv7"], "article_id"=>665887, "categories"=>["Medicine", "Pharmacology", "Physiology", "Biotechnology", "Immunology", "Infectious Diseases"], "users"=>["William S. Pomat", "Anita H. J. van den Biggelaar", "Suparat Phuanukoonnon", "Jacinta Francis", "Peter Jacoby", "Peter M. Siba", "Michael P. Alpers", "John C. Reeder", "Patrick G. Holt", "Peter C. Richmond", "Deborah Lehmann"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0056698.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Obstetric_and_newborn_characteristics_according_to_randomization_to_neonatal_or_infant_PCV7_schedule_or_to_control_group_/665887", "title"=>"Obstetric and newborn characteristics according to randomization to neonatal or infant PCV7 schedule or to control group.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-02-22 01:38:07"}

PMC Usage Stats | Further Information

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Relative Metric

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