tetano
Editor, Senior Moderator
Pediatric Infectious Disease Journal:
POST AUTHOR CORRECTIONS, 6 October 2011
doi: 10.1097/INF.0b013e3182372c6a
Drug and Vaccine Phase II-IV Reports: PDF Only
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate Vaccine
Frenck, Robert Jr. MD; Thompson, Allison MD, FAAP; Yeh, Sylvia H. MD; London, Arnold MD; Sidhu, Mohinder S. PhD; Patterson, Scott PhD; Gruber, William C. MD; Emini, Emilio A. PhD; Scott, Daniel A. MD; Gurtman, Alejandra MD; the 3011 Study Group
Published Ahead-of-Print
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Abstract
Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has proven highly effective in preventing diseases caused by Streptococcus pneumoniae; however, in some regions, serotype coverage is limited. A recently licensed 13-valent PCV (PCV13) was developed to provide additional coverage globally. Children previously vaccinated with PCV7 could benefit from supplemental vaccination with PCV13 to provide protection against the 6 additional serotypes in PCV13. This open-label study evaluated the immunogenicity and safety of administering PCV13 to healthy children previously vaccinated with PCV7.
Methods: Children between 15 months and 2 years of age (group 1) received 2 doses of PCV13; children between 2 and 5 years (group 2) received 1 dose. Antibodies (immunoglobulin G) against the polysaccharide antigens in PCV13 were measured before vaccination and 1 month after the final dose. Solicited local and systemic adverse events (AEs) were collected for 7 days postvaccination. Unsolicited and serious AEs were collected throughout.
Results: A total of 284 subjects (group 1: n = 109; group 2: n = 175) had blood available for testing. Antipneumococcal immunoglobulin G geometric mean fold rises ranged from 2- to 19-fold for the PCV7 serotypes and from approximately 2- to 124-fold for the 6 additional serotypes. Additionally, postvaccination titers in excess of 0.35 [mu]g/mL, the serologic correlate of immunity against pneumococcus for children, occurred in >=98% of subjects in both groups for 12 of the 13 serotypes in PCV13. Slightly lower percentage of subjects, 94.5% and 92% of subjects in group 1 and group 2, respectively, had postvaccine titers for serotype 3 exceeding the serologic correlate of immunity. Reactogenicity was typically mild and self-limited, and unsolicited AEs reported were generally consistent with common childhood illnesses.
Conclusion: PCV13 was safe and immunogenic when administered to children who had previously received PCV7, and can be used for supplemental vaccination to provide additional protection against the 6 additional serotypes.
(C) 2011 Lippincott Williams & Wilkins, Inc.
http://journals.lww.com/pidj/Abstract/publishahead/Immunogenicity_and_Safety_of_13_valent.98903.aspx
POST AUTHOR CORRECTIONS, 6 October 2011
doi: 10.1097/INF.0b013e3182372c6a
Drug and Vaccine Phase II-IV Reports: PDF Only
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate Vaccine
Frenck, Robert Jr. MD; Thompson, Allison MD, FAAP; Yeh, Sylvia H. MD; London, Arnold MD; Sidhu, Mohinder S. PhD; Patterson, Scott PhD; Gruber, William C. MD; Emini, Emilio A. PhD; Scott, Daniel A. MD; Gurtman, Alejandra MD; the 3011 Study Group
Published Ahead-of-Print
Collapse Box
Abstract
Background: The 7-valent pneumococcal conjugate vaccine (PCV7) has proven highly effective in preventing diseases caused by Streptococcus pneumoniae; however, in some regions, serotype coverage is limited. A recently licensed 13-valent PCV (PCV13) was developed to provide additional coverage globally. Children previously vaccinated with PCV7 could benefit from supplemental vaccination with PCV13 to provide protection against the 6 additional serotypes in PCV13. This open-label study evaluated the immunogenicity and safety of administering PCV13 to healthy children previously vaccinated with PCV7.
Methods: Children between 15 months and 2 years of age (group 1) received 2 doses of PCV13; children between 2 and 5 years (group 2) received 1 dose. Antibodies (immunoglobulin G) against the polysaccharide antigens in PCV13 were measured before vaccination and 1 month after the final dose. Solicited local and systemic adverse events (AEs) were collected for 7 days postvaccination. Unsolicited and serious AEs were collected throughout.
Results: A total of 284 subjects (group 1: n = 109; group 2: n = 175) had blood available for testing. Antipneumococcal immunoglobulin G geometric mean fold rises ranged from 2- to 19-fold for the PCV7 serotypes and from approximately 2- to 124-fold for the 6 additional serotypes. Additionally, postvaccination titers in excess of 0.35 [mu]g/mL, the serologic correlate of immunity against pneumococcus for children, occurred in >=98% of subjects in both groups for 12 of the 13 serotypes in PCV13. Slightly lower percentage of subjects, 94.5% and 92% of subjects in group 1 and group 2, respectively, had postvaccine titers for serotype 3 exceeding the serologic correlate of immunity. Reactogenicity was typically mild and self-limited, and unsolicited AEs reported were generally consistent with common childhood illnesses.
Conclusion: PCV13 was safe and immunogenic when administered to children who had previously received PCV7, and can be used for supplemental vaccination to provide additional protection against the 6 additional serotypes.
(C) 2011 Lippincott Williams & Wilkins, Inc.
http://journals.lww.com/pidj/Abstract/publishahead/Immunogenicity_and_Safety_of_13_valent.98903.aspx