Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants.
Pediatr Infect Dis J
; 28(3): 186-93, 2009 Mar.
Article
em En
| MEDLINE
| ID: mdl-19209097
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 > or =14 using a serum bactericidal assay with human complement (hSBA).RESULTS:
Two doses of MenACWY-CRM induced hSBA titers > or =14 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 > or =14 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas Conjugadas
/
Vacinas Meningocócicas
/
Memória Imunológica
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Infecções Meningocócicas
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Anticorpos Antibacterianos
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Neisseria meningitidis
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
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Infant
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Male
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article