BACKGROUND: The highest rate of invasive meningococcal disease is among children under 2 years of age. There is currently no licensed quadrivalent (serogroups A, C, W-135, and Y) meningococcal glycoconjugate vaccine approved for infants. We evaluated the immunogenicity and reactogenicity of a novel quadrivalent nonadjuvanted meningococcal glycoconjugate vaccine (MenACWY-CRM) in healthy infants. METHODS: One hundred eighty infants (90 in Canada and 90 in the United Kingdom) received 2 doses of MenACWY-CRM at 2 and 4 months of age administered concomitantly with routine infant vaccines. At 12 months of age, the Canadian infants received either MenACWY-CRM or a reduced dose of a licensed meningococcal polysaccharide vaccine. In the United Kingdom, all infants received a further dose of MenACWY-CRM. The serological marker of protection was a titer of \textgreater or =1:4 using a serum bactericidal assay with human complement (hSBA). RESULTS: Two doses of MenACWY-CRM induced hSBA titers \textgreater or =1:4 in 57\% (95\% confidence interval CI: 45-67) and 50\% (95\% CI: 38-62) of infants against serogroup A in Canada and the United Kingdom, respectively, 93\% (95\% CI: 85-97) and 86\% (95\% CI: 46-93) against serogroup C, 95\% (95\% CI: 87-99) and 82\% (95\% CI: 71-90) against serogroup W-135, and 91\% (95\% CI: 82-96) and 74\% (95\% CI: 63-83) against serogroup Y. After a booster dose of MenACWY-CRM at 12 months, at least 94\% of participants achieved hSBA titers \textgreater or =1:4 against each of the serogroups C, W-135, and Y and more than 79\% against serogroup A. The vaccine was well tolerated. CONCLUSIONS: The nonadjuvanted MenACWY-CRM is immunogenic and well tolerated in infancy and could provide broad protection against meningococcal disease in this vulnerable age group.
%0 Journal Article
%1 perrett_immunogenicity_2009
%A Perrett, Kirsten P
%A Snape, Matthew D
%A Ford, Karen J
%A John, Tessa M
%A Yu, Ly-Mee M
%A Langley, Joanne M
%A McNeil, Shelly
%A Dull, Peter M
%A Ceddia, Francesca
%A Anemona, Alessandra
%A Halperin, Scott A
%A Dobson, Simon
%A Pollard, Andrew J
%D 2009
%J The Pediatric Infectious Disease Journal
%K Adjuvants, Antibodies, Bacterial, Conjugate Female, Humans, Immunologic Immunologic, Infant, Infections, Male, Memory, Meningococcal Neisseria Outcome, Serotyping, Treatment Vaccines, meningitidis,
%N 3
%P 186--193
%R 10.1097/INF.0b013e31818e037d
%T Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants
%U http://www.ncbi.nlm.nih.gov/pubmed/19209097
%V 28
%X BACKGROUND: The highest rate of invasive meningococcal disease is among children under 2 years of age. There is currently no licensed quadrivalent (serogroups A, C, W-135, and Y) meningococcal glycoconjugate vaccine approved for infants. We evaluated the immunogenicity and reactogenicity of a novel quadrivalent nonadjuvanted meningococcal glycoconjugate vaccine (MenACWY-CRM) in healthy infants. METHODS: One hundred eighty infants (90 in Canada and 90 in the United Kingdom) received 2 doses of MenACWY-CRM at 2 and 4 months of age administered concomitantly with routine infant vaccines. At 12 months of age, the Canadian infants received either MenACWY-CRM or a reduced dose of a licensed meningococcal polysaccharide vaccine. In the United Kingdom, all infants received a further dose of MenACWY-CRM. The serological marker of protection was a titer of \textgreater or =1:4 using a serum bactericidal assay with human complement (hSBA). RESULTS: Two doses of MenACWY-CRM induced hSBA titers \textgreater or =1:4 in 57\% (95\% confidence interval CI: 45-67) and 50\% (95\% CI: 38-62) of infants against serogroup A in Canada and the United Kingdom, respectively, 93\% (95\% CI: 85-97) and 86\% (95\% CI: 46-93) against serogroup C, 95\% (95\% CI: 87-99) and 82\% (95\% CI: 71-90) against serogroup W-135, and 91\% (95\% CI: 82-96) and 74\% (95\% CI: 63-83) against serogroup Y. After a booster dose of MenACWY-CRM at 12 months, at least 94\% of participants achieved hSBA titers \textgreater or =1:4 against each of the serogroups C, W-135, and Y and more than 79\% against serogroup A. The vaccine was well tolerated. CONCLUSIONS: The nonadjuvanted MenACWY-CRM is immunogenic and well tolerated in infancy and could provide broad protection against meningococcal disease in this vulnerable age group.
@article{perrett_immunogenicity_2009,
abstract = {{BACKGROUND:} The highest rate of invasive meningococcal disease is among children under 2 years of age. There is currently no licensed quadrivalent (serogroups A, C, W-135, and Y) meningococcal glycoconjugate vaccine approved for infants. We evaluated the immunogenicity and reactogenicity of a novel quadrivalent nonadjuvanted meningococcal glycoconjugate vaccine {(MenACWY-CRM)} in healthy infants. {METHODS:} One hundred eighty infants (90 in Canada and 90 in the United Kingdom) received 2 doses of {MenACWY-CRM} at 2 and 4 months of age administered concomitantly with routine infant vaccines. At 12 months of age, the Canadian infants received either {MenACWY-CRM} or a reduced dose of a licensed meningococcal polysaccharide vaccine. In the United Kingdom, all infants received a further dose of {MenACWY-CRM.} The serological marker of protection was a titer of {\textgreater} or =1:4 using a serum bactericidal assay with human complement {(hSBA).} {RESULTS:} Two doses of {MenACWY-CRM} induced {hSBA} titers {\textgreater} or =1:4 in 57\% (95\% confidence interval {[CI]:} 45-67) and 50\% (95\% {CI:} 38-62) of infants against serogroup A in Canada and the United Kingdom, respectively, 93\% (95\% {CI:} 85-97) and 86\% (95\% {CI:} 46-93) against serogroup C, 95\% (95\% {CI:} 87-99) and 82\% (95\% {CI:} 71-90) against serogroup W-135, and 91\% (95\% {CI:} 82-96) and 74\% (95\% {CI:} 63-83) against serogroup Y. After a booster dose of {MenACWY-CRM} at 12 months, at least 94\% of participants achieved {hSBA} titers {\textgreater} or =1:4 against each of the serogroups C, W-135, and Y and more than 79\% against serogroup A. The vaccine was well tolerated. {CONCLUSIONS:} The nonadjuvanted {MenACWY-CRM} is immunogenic and well tolerated in infancy and could provide broad protection against meningococcal disease in this vulnerable age group.},
added-at = {2011-03-11T10:05:34.000+0100},
author = {Perrett, Kirsten P and Snape, Matthew D and Ford, Karen J and John, Tessa M and Yu, {Ly-Mee} M and Langley, Joanne M and {McNeil}, Shelly and Dull, Peter M and Ceddia, Francesca and Anemona, Alessandra and Halperin, Scott A and Dobson, Simon and Pollard, Andrew J},
biburl = {https://www.bibsonomy.org/bibtex/23cd547c2fd1801d0480bf9379dad9fc5/jelias},
doi = {10.1097/INF.0b013e31818e037d},
interhash = {c924a5697174073afb1640002c775818},
intrahash = {3cd547c2fd1801d0480bf9379dad9fc5},
issn = {0891-3668},
journal = {The Pediatric Infectious Disease Journal},
keywords = {Adjuvants, Antibodies, Bacterial, Conjugate Female, Humans, Immunologic Immunologic, Infant, Infections, Male, Memory, Meningococcal Neisseria Outcome, Serotyping, Treatment Vaccines, meningitidis,},
month = mar,
note = {{PMID:} 19209097},
number = 3,
pages = {186--193},
timestamp = {2011-03-11T10:06:46.000+0100},
title = {Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants},
url = {http://www.ncbi.nlm.nih.gov/pubmed/19209097},
volume = 28,
year = 2009
}