Safety and immunogenicity of CRM197-conjugated pneumococcal-meningococcal C combination vaccine (9vPnC-MnCC) whether given in two or three primary doses

2.50
Hdl Handle:
http://hdl.handle.net/2336/32852
Title:
Safety and immunogenicity of CRM197-conjugated pneumococcal-meningococcal C combination vaccine (9vPnC-MnCC) whether given in two or three primary doses
Authors:
Sigurdardottir, Sigurveig Th; Davidsdottir, Katrin; Arason, Vilhjalmur A; Jonsdottir, Olof; Laudat, France; Gruber, William C; Jonsdottir, Ingileif
Citation:
Vaccine 2008, 26(33):4178-86
Issue Date:
5-Aug-2008
Abstract:
This randomized trial compares safety and immunogenicity when vaccinating infants with a pneumococcal-meningococcal conjugate vaccine in two doses vs. three doses. Infants (N=223) received 9vPnC-MnCC (CRM197-conjugated pneumococcal serotypes 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F and meningococcal C polysaccharides) either at 3 and 5 or 3, 4 and 5 months and a booster with either 9vPnC-MnCC or 23-valent pneumococcal-polysaccharide vaccine (23vPPS) and CRM197-MnCC, at 12 months. Safety was monitored and IgG measured at 3, 6, 12 and 13 months in all subjects and serum bactericidal activity (SBA) in half. The 9vPnC-MnCC vaccine was safe and induced significant IgG to all components. Three doses induced higher antibody GMCs (geometric mean concentrations) at 6 months to seven of nine pneumococcal serotypes. This was most significant for 6B and 23F (p<0.001), that also showed lower rate of responders >0.35 (6B, 23F) and >0.5mug/mL (6B). Antibody GMCs remained lower following 9vPnC-MnCC booster in subjects primed with two doses although only significant for serotype 18C. Significant memory responses were observed 1 week after the 23vPPS toddler dose. MnCC-IgG GMC was lower after two doses, however with comparable SBA. This study shows that the 9vPnC-MnCC vaccine is safe and induces successful immunological memory, whether given in two or three primary doses.
Description:
To access publisher full text version of this article. Please click on the hyperlink in Additional Links field
Additional Links:
http://www.sciencedirect.com/science/article/B6TD4-4SSG6XF-5/1/f21dd10431044f615c73d6fa4cca34b8

Full metadata record

DC FieldValue Language
dc.contributor.authorSigurdardottir, Sigurveig Th-
dc.contributor.authorDavidsdottir, Katrin-
dc.contributor.authorArason, Vilhjalmur A-
dc.contributor.authorJonsdottir, Olof-
dc.contributor.authorLaudat, France-
dc.contributor.authorGruber, William C-
dc.contributor.authorJonsdottir, Ingileif-
dc.date.accessioned2008-07-23T14:07:30Z-
dc.date.available2008-07-23T14:07:30Z-
dc.date.issued2008-08-05-
dc.date.submitted2008-07-22-
dc.identifier.citationVaccine 2008, 26(33):4178-86en
dc.identifier.issn0264-410X-
dc.identifier.pmid18606481-
dc.identifier.doi10.1016/j.vaccine.2008.05.072-
dc.identifier.urihttp://hdl.handle.net/2336/32852-
dc.descriptionTo access publisher full text version of this article. Please click on the hyperlink in Additional Links fielden
dc.description.abstractThis randomized trial compares safety and immunogenicity when vaccinating infants with a pneumococcal-meningococcal conjugate vaccine in two doses vs. three doses. Infants (N=223) received 9vPnC-MnCC (CRM197-conjugated pneumococcal serotypes 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F and meningococcal C polysaccharides) either at 3 and 5 or 3, 4 and 5 months and a booster with either 9vPnC-MnCC or 23-valent pneumococcal-polysaccharide vaccine (23vPPS) and CRM197-MnCC, at 12 months. Safety was monitored and IgG measured at 3, 6, 12 and 13 months in all subjects and serum bactericidal activity (SBA) in half. The 9vPnC-MnCC vaccine was safe and induced significant IgG to all components. Three doses induced higher antibody GMCs (geometric mean concentrations) at 6 months to seven of nine pneumococcal serotypes. This was most significant for 6B and 23F (p<0.001), that also showed lower rate of responders >0.35 (6B, 23F) and >0.5mug/mL (6B). Antibody GMCs remained lower following 9vPnC-MnCC booster in subjects primed with two doses although only significant for serotype 18C. Significant memory responses were observed 1 week after the 23vPPS toddler dose. MnCC-IgG GMC was lower after two doses, however with comparable SBA. This study shows that the 9vPnC-MnCC vaccine is safe and induces successful immunological memory, whether given in two or three primary doses.en
dc.language.isoenen
dc.publisherElsevier Scienceen
dc.relation.urlhttp://www.sciencedirect.com/science/article/B6TD4-4SSG6XF-5/1/f21dd10431044f615c73d6fa4cca34b8en
dc.subject.meshImmunization, Secondaryen
dc.subject.meshMeningococcal Vaccinesen
dc.subject.meshPneumococcal Vaccinesen
dc.subject.meshAntibodies, Bacterialen
dc.titleSafety and immunogenicity of CRM197-conjugated pneumococcal-meningococcal C combination vaccine (9vPnC-MnCC) whether given in two or three primary dosesen
dc.typeArticleen
dc.contributor.departmentDepartment of Immunology, Landspitali University Hospital, Reykjavik, Iceland; Faculty of Medicine, University of Iceland, Reykjavik, Iceland.en
dc.identifier.journalVaccineen

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