Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age
BACKGROUND:A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines. METHODS:Healthy infants randomized in a previous study for priming at 2, 4, and 6 mon...
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| Veröffentlicht in: | The Pediatric infectious disease journal 2008-07, Vol.27 (7), p.579-588 |
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| creator | Tejedor, Juan C Moro, Manuel Merino, José Manuel Gómez-Campderá, José Antonio García-del-Rio, Manuel Jurado, Antonio Díez-Delgado, Francisco Javier Omeñaca, Félix García-Sicilia, José Ruiz-Contreras, Jesús Martin-Ancel, Ana Roca, Joan Boceta, Reyes García-Corbeira, Pilar Maechler, Gudrun Boutriau, Dominique |
| description | BACKGROUND:A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.
METHODS:Healthy infants randomized in a previous study for priming at 2, 4, and 6 monthsHib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C™; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec™; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.
RESULTS:Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration ≥0.15 μg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers ≥1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels ≥1 μg/mL, and 99.6% had SBA-MenC titers ≥1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers ≥1:8 persisted in 92.7% subjects and anti-PRP ≥0.15 μg/mL persisted in 99.4%.
CONCLUSIONS:Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile. |
| doi_str_mv | 10.1097/INF.0b013e31816b4561 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_69305836</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>69305836</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3801-7259279b8f4131edf4ac7e83494117955f60089e88e99228cdfffde01d6c2a563</originalsourceid><addsrcrecordid>eNpdks1uEzEUhQdERUPhDRDyBnZTfMfz41mWQNtIJSBIYTny2HcSlxk72J6WsOIdeEOeBIdERLCyfPSd42sfJ8lToKdA6-rlbH5-SlsKDBlwKNu8KOF-MoGCZSmtefUgmVBeQ8rKkh8nj7y_oZSyHOjD5Bh4EWWoJ_eOZsMwGrtEo6UOGyKMIh9QyHCQbEcEeWWtD-jIa-txp8ztLfZkaodWG1TkUuBg1yvdj55o0_Ujmu8CyWKzRtKmc9Teo9OCDDHWLHXQSnvyEZ1dOjuuyTRdYBAmmhf2m9UqBpubcSkCkk9CyngEudC3aEiwkVCqR-e3cwD79eMn5OStNWH1RzlbIvmsw4qcmaBbqzbkfWR1nN5IJNfrbQKDfw2Pk6NO9B6f7NeT5Pr8zWJ6mV69u5hNz65SyTiFtMqKOqvqlnc5MEDV5UJWyFle5wBVXRRdSeObI-dY11nGpeq6TiEFVcpMFCU7SV7sctfOfh3Rh2bQXmLfC4N29E1ZM1pwtgXzHSid9d5h16ydHoTbNECbbf1NrL_5v_5oe7bPH9sB1cG07zsCz_eA8FL0nRNGav-Xy2jOGVT8cP6d7WPt_ks_3qFrVij6sGriR6JlXuRpFq9Lq7hLtxKw3yrzy94</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>69305836</pqid></control><display><type>article</type><title>Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Tejedor, Juan C ; Moro, Manuel ; Merino, José Manuel ; Gómez-Campderá, José Antonio ; García-del-Rio, Manuel ; Jurado, Antonio ; Díez-Delgado, Francisco Javier ; Omeñaca, Félix ; García-Sicilia, José ; Ruiz-Contreras, Jesús ; Martin-Ancel, Ana ; Roca, Joan ; Boceta, Reyes ; García-Corbeira, Pilar ; Maechler, Gudrun ; Boutriau, Dominique</creator><creatorcontrib>Tejedor, Juan C ; Moro, Manuel ; Merino, José Manuel ; Gómez-Campderá, José Antonio ; García-del-Rio, Manuel ; Jurado, Antonio ; Díez-Delgado, Francisco Javier ; Omeñaca, Félix ; García-Sicilia, José ; Ruiz-Contreras, Jesús ; Martin-Ancel, Ana ; Roca, Joan ; Boceta, Reyes ; García-Corbeira, Pilar ; Maechler, Gudrun ; Boutriau, Dominique ; Spanish 102547 Study Group</creatorcontrib><description>BACKGROUND:A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.
METHODS:Healthy infants randomized in a previous study for priming at 2, 4, and 6 monthsHib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C™; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec™; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.
RESULTS:Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration ≥0.15 μg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers ≥1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels ≥1 μg/mL, and 99.6% had SBA-MenC titers ≥1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers ≥1:8 persisted in 92.7% subjects and anti-PRP ≥0.15 μg/mL persisted in 99.4%.
CONCLUSIONS:Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile.</description><identifier>ISSN: 0891-3668</identifier><identifier>EISSN: 1532-0987</identifier><identifier>DOI: 10.1097/INF.0b013e31816b4561</identifier><identifier>PMID: 18536619</identifier><identifier>CODEN: PIDJEV</identifier><language>eng</language><publisher>Baltimore, MD: Lippincott Williams & Wilkins, Inc</publisher><subject>Antibodies, Bacterial - blood ; Bacterial diseases ; Bacterial diseases of the nervous system. Bacterial myositis ; Biological and medical sciences ; Female ; General aspects ; Haemophilus Vaccines - adverse effects ; Haemophilus Vaccines - immunology ; Human bacterial diseases ; Humans ; Immunization, Secondary ; Infant ; Infectious diseases ; Longitudinal Studies ; Male ; Medical sciences ; Microbial Viability ; Neutralization Tests ; Polysaccharides - immunology ; Tetanus Toxoid - adverse effects ; Tetanus Toxoid - immunology ; Time Factors ; Vaccines, Conjugate - adverse effects ; Vaccines, Conjugate - immunology</subject><ispartof>The Pediatric infectious disease journal, 2008-07, Vol.27 (7), p.579-588</ispartof><rights>2008 Lippincott Williams & Wilkins, Inc.</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3801-7259279b8f4131edf4ac7e83494117955f60089e88e99228cdfffde01d6c2a563</citedby><cites>FETCH-LOGICAL-c3801-7259279b8f4131edf4ac7e83494117955f60089e88e99228cdfffde01d6c2a563</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20483178$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18536619$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tejedor, Juan C</creatorcontrib><creatorcontrib>Moro, Manuel</creatorcontrib><creatorcontrib>Merino, José Manuel</creatorcontrib><creatorcontrib>Gómez-Campderá, José Antonio</creatorcontrib><creatorcontrib>García-del-Rio, Manuel</creatorcontrib><creatorcontrib>Jurado, Antonio</creatorcontrib><creatorcontrib>Díez-Delgado, Francisco Javier</creatorcontrib><creatorcontrib>Omeñaca, Félix</creatorcontrib><creatorcontrib>García-Sicilia, José</creatorcontrib><creatorcontrib>Ruiz-Contreras, Jesús</creatorcontrib><creatorcontrib>Martin-Ancel, Ana</creatorcontrib><creatorcontrib>Roca, Joan</creatorcontrib><creatorcontrib>Boceta, Reyes</creatorcontrib><creatorcontrib>García-Corbeira, Pilar</creatorcontrib><creatorcontrib>Maechler, Gudrun</creatorcontrib><creatorcontrib>Boutriau, Dominique</creatorcontrib><creatorcontrib>Spanish 102547 Study Group</creatorcontrib><title>Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age</title><title>The Pediatric infectious disease journal</title><addtitle>Pediatr Infect Dis J</addtitle><description>BACKGROUND:A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.
METHODS:Healthy infants randomized in a previous study for priming at 2, 4, and 6 monthsHib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C™; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec™; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.
RESULTS:Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration ≥0.15 μg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers ≥1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels ≥1 μg/mL, and 99.6% had SBA-MenC titers ≥1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers ≥1:8 persisted in 92.7% subjects and anti-PRP ≥0.15 μg/mL persisted in 99.4%.
CONCLUSIONS:Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile.</description><subject>Antibodies, Bacterial - blood</subject><subject>Bacterial diseases</subject><subject>Bacterial diseases of the nervous system. Bacterial myositis</subject><subject>Biological and medical sciences</subject><subject>Female</subject><subject>General aspects</subject><subject>Haemophilus Vaccines - adverse effects</subject><subject>Haemophilus Vaccines - immunology</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Immunization, Secondary</subject><subject>Infant</subject><subject>Infectious diseases</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbial Viability</subject><subject>Neutralization Tests</subject><subject>Polysaccharides - immunology</subject><subject>Tetanus Toxoid - adverse effects</subject><subject>Tetanus Toxoid - immunology</subject><subject>Time Factors</subject><subject>Vaccines, Conjugate - adverse effects</subject><subject>Vaccines, Conjugate - immunology</subject><issn>0891-3668</issn><issn>1532-0987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdks1uEzEUhQdERUPhDRDyBnZTfMfz41mWQNtIJSBIYTny2HcSlxk72J6WsOIdeEOeBIdERLCyfPSd42sfJ8lToKdA6-rlbH5-SlsKDBlwKNu8KOF-MoGCZSmtefUgmVBeQ8rKkh8nj7y_oZSyHOjD5Bh4EWWoJ_eOZsMwGrtEo6UOGyKMIh9QyHCQbEcEeWWtD-jIa-txp8ztLfZkaodWG1TkUuBg1yvdj55o0_Ujmu8CyWKzRtKmc9Teo9OCDDHWLHXQSnvyEZ1dOjuuyTRdYBAmmhf2m9UqBpubcSkCkk9CyngEudC3aEiwkVCqR-e3cwD79eMn5OStNWH1RzlbIvmsw4qcmaBbqzbkfWR1nN5IJNfrbQKDfw2Pk6NO9B6f7NeT5Pr8zWJ6mV69u5hNz65SyTiFtMqKOqvqlnc5MEDV5UJWyFle5wBVXRRdSeObI-dY11nGpeq6TiEFVcpMFCU7SV7sctfOfh3Rh2bQXmLfC4N29E1ZM1pwtgXzHSid9d5h16ydHoTbNECbbf1NrL_5v_5oe7bPH9sB1cG07zsCz_eA8FL0nRNGav-Xy2jOGVT8cP6d7WPt_ks_3qFrVij6sGriR6JlXuRpFq9Lq7hLtxKw3yrzy94</recordid><startdate>200807</startdate><enddate>200807</enddate><creator>Tejedor, Juan C</creator><creator>Moro, Manuel</creator><creator>Merino, José Manuel</creator><creator>Gómez-Campderá, José Antonio</creator><creator>García-del-Rio, Manuel</creator><creator>Jurado, Antonio</creator><creator>Díez-Delgado, Francisco Javier</creator><creator>Omeñaca, Félix</creator><creator>García-Sicilia, José</creator><creator>Ruiz-Contreras, Jesús</creator><creator>Martin-Ancel, Ana</creator><creator>Roca, Joan</creator><creator>Boceta, Reyes</creator><creator>García-Corbeira, Pilar</creator><creator>Maechler, Gudrun</creator><creator>Boutriau, Dominique</creator><general>Lippincott Williams & Wilkins, Inc</general><general>Lippincott</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200807</creationdate><title>Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age</title><author>Tejedor, Juan C ; Moro, Manuel ; Merino, José Manuel ; Gómez-Campderá, José Antonio ; García-del-Rio, Manuel ; Jurado, Antonio ; Díez-Delgado, Francisco Javier ; Omeñaca, Félix ; García-Sicilia, José ; Ruiz-Contreras, Jesús ; Martin-Ancel, Ana ; Roca, Joan ; Boceta, Reyes ; García-Corbeira, Pilar ; Maechler, Gudrun ; Boutriau, Dominique</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3801-7259279b8f4131edf4ac7e83494117955f60089e88e99228cdfffde01d6c2a563</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Antibodies, Bacterial - blood</topic><topic>Bacterial diseases</topic><topic>Bacterial diseases of the nervous system. Bacterial myositis</topic><topic>Biological and medical sciences</topic><topic>Female</topic><topic>General aspects</topic><topic>Haemophilus Vaccines - adverse effects</topic><topic>Haemophilus Vaccines - immunology</topic><topic>Human bacterial diseases</topic><topic>Humans</topic><topic>Immunization, Secondary</topic><topic>Infant</topic><topic>Infectious diseases</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbial Viability</topic><topic>Neutralization Tests</topic><topic>Polysaccharides - immunology</topic><topic>Tetanus Toxoid - adverse effects</topic><topic>Tetanus Toxoid - immunology</topic><topic>Time Factors</topic><topic>Vaccines, Conjugate - adverse effects</topic><topic>Vaccines, Conjugate - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tejedor, Juan C</creatorcontrib><creatorcontrib>Moro, Manuel</creatorcontrib><creatorcontrib>Merino, José Manuel</creatorcontrib><creatorcontrib>Gómez-Campderá, José Antonio</creatorcontrib><creatorcontrib>García-del-Rio, Manuel</creatorcontrib><creatorcontrib>Jurado, Antonio</creatorcontrib><creatorcontrib>Díez-Delgado, Francisco Javier</creatorcontrib><creatorcontrib>Omeñaca, Félix</creatorcontrib><creatorcontrib>García-Sicilia, José</creatorcontrib><creatorcontrib>Ruiz-Contreras, Jesús</creatorcontrib><creatorcontrib>Martin-Ancel, Ana</creatorcontrib><creatorcontrib>Roca, Joan</creatorcontrib><creatorcontrib>Boceta, Reyes</creatorcontrib><creatorcontrib>García-Corbeira, Pilar</creatorcontrib><creatorcontrib>Maechler, Gudrun</creatorcontrib><creatorcontrib>Boutriau, Dominique</creatorcontrib><creatorcontrib>Spanish 102547 Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Pediatric infectious disease journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tejedor, Juan C</au><au>Moro, Manuel</au><au>Merino, José Manuel</au><au>Gómez-Campderá, José Antonio</au><au>García-del-Rio, Manuel</au><au>Jurado, Antonio</au><au>Díez-Delgado, Francisco Javier</au><au>Omeñaca, Félix</au><au>García-Sicilia, José</au><au>Ruiz-Contreras, Jesús</au><au>Martin-Ancel, Ana</au><au>Roca, Joan</au><au>Boceta, Reyes</au><au>García-Corbeira, Pilar</au><au>Maechler, Gudrun</au><au>Boutriau, Dominique</au><aucorp>Spanish 102547 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age</atitle><jtitle>The Pediatric infectious disease journal</jtitle><addtitle>Pediatr Infect Dis J</addtitle><date>2008-07</date><risdate>2008</risdate><volume>27</volume><issue>7</issue><spage>579</spage><epage>588</epage><pages>579-588</pages><issn>0891-3668</issn><eissn>1532-0987</eissn><coden>PIDJEV</coden><abstract>BACKGROUND:A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines.
METHODS:Healthy infants randomized in a previous study for priming at 2, 4, and 6 monthsHib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV (N = 87); MenC-TT primed group, 2 doses of MenC-TT (NeisVac-C™; Baxter Healthcare SA, Zuürich, Switzerland) + 3 doses of DTPa/Hib containing vaccines (N = 178); MenC-CRM primed group, 3 doses of MenC-CRM197(Meningitec™; Wyeth Corporation Delaware, Madison, NJ) + DTPa-HBV-IPV/Hib (N = 93). At 13-14 months of age, Hib-MenC-TT and MenC-TT primed groups received a Hib-MenC-TT booster dose and the MenC-CRM primed group a booster dose of DTPa-HBV-IPV/Hib. Blood samples were taken before and at 1 and 18 months postbooster.
RESULTS:Before the booster dose, persistence of anti-polyribosyl ribitol phosphate (PRP) antibody concentration ≥0.15 μg/mL in the Hib-MenC-TT (96.4%) and MenC-TT (96.1%) primed groups and of MenC bactericidal titers ≥1:8 in the Hib-MenC-TT primed group (96.3%) was statistically significantly higher than in the MenC-CRM primed group (86.4% and 85.4%, respectively). One month after the Hib-MenC-TT booster, 99.2% subjects in the Hib-MenC-TT primed + MenC-TT primed pooled groups had anti-PRP levels ≥1 μg/mL, and 99.6% had SBA-MenC titers ≥1:128. The Hib-MenC-TT booster tended to be less reactogenic than the DTPa-HBV-IPV/Hib control and no serious adverse events related to vaccination were reported. Eighteen months after boosting with Hib-MenC-TT, SBA-MenC titers ≥1:8 persisted in 92.7% subjects and anti-PRP ≥0.15 μg/mL persisted in 99.4%.
CONCLUSIONS:Primary immunization with 3 doses of Hib-MenC-TT coadministered with DTPa-HBV-IPV induced antibodies that persisted up to the second year of life. The Hib-MenC-TT booster administered to primed toddlers induced robust and persistent antibody responses to both the Hib and MenC components and had an acceptable safety profile.</abstract><cop>Baltimore, MD</cop><cop>Philadelphia, PA</cop><cop>Hagerstown, MD</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>18536619</pmid><doi>10.1097/INF.0b013e31816b4561</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0891-3668 |
| ispartof | The Pediatric infectious disease journal, 2008-07, Vol.27 (7), p.579-588 |
| issn | 0891-3668 1532-0987 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_69305836 |
| source | MEDLINE; Journals@Ovid Complete |
| subjects | Antibodies, Bacterial - blood Bacterial diseases Bacterial diseases of the nervous system. Bacterial myositis Biological and medical sciences Female General aspects Haemophilus Vaccines - adverse effects Haemophilus Vaccines - immunology Human bacterial diseases Humans Immunization, Secondary Infant Infectious diseases Longitudinal Studies Male Medical sciences Microbial Viability Neutralization Tests Polysaccharides - immunology Tetanus Toxoid - adverse effects Tetanus Toxoid - immunology Time Factors Vaccines, Conjugate - adverse effects Vaccines, Conjugate - immunology |
| title | Immunogenicity and Reactogenicity of a Booster Dose of a Novel Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C-Tetanus Toxoid Conjugate Vaccine Given to Toddlers of 13–14 Months of Age With Antibody Persistence Up to 31 Months of Age |
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