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Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants.
Pediatr Infect Dis J. 2009 Mar; 28(3):186-93.PI

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 =1:4 using a serum bactericidal assay with human complement (hSBA).

RESULTS

Two doses of MenACWY-CRM induced hSBA titers > 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 > 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.

Authors+Show Affiliations

Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Centre for Vaccinology and Tropical Medicine, Churchill Hospital, Oxford, UK. Kirsten.perrett@paediatrics.ox.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19209097

Citation

Perrett, Kirsten P., et al. "Immunogenicity and Immune Memory of a Nonadjuvanted Quadrivalent Meningococcal Glycoconjugate Vaccine in Infants." The Pediatric Infectious Disease Journal, vol. 28, no. 3, 2009, pp. 186-93.
Perrett KP, Snape MD, Ford KJ, et al. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009;28(3):186-93.
Perrett, K. P., Snape, M. D., Ford, K. J., John, T. M., Yu, L. M., Langley, J. M., McNeil, S., Dull, P. M., Ceddia, F., Anemona, A., Halperin, S. A., Dobson, S., & Pollard, A. J. (2009). Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. The Pediatric Infectious Disease Journal, 28(3), 186-93. https://doi.org/10.1097/INF.0b013e31818e037d
Perrett KP, et al. Immunogenicity and Immune Memory of a Nonadjuvanted Quadrivalent Meningococcal Glycoconjugate Vaccine in Infants. Pediatr Infect Dis J. 2009;28(3):186-93. PubMed PMID: 19209097.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. AU - Perrett,Kirsten P, AU - Snape,Matthew D, AU - Ford,Karen J, AU - John,Tessa M, AU - Yu,Ly-Mee M, AU - Langley,Joanne M, AU - McNeil,Shelly, AU - Dull,Peter M, AU - Ceddia,Francesca, AU - Anemona,Alessandra, AU - Halperin,Scott A, AU - Dobson,Simon, AU - Pollard,Andrew J, PY - 2009/2/12/entrez PY - 2009/2/12/pubmed PY - 2009/4/4/medline SP - 186 EP - 93 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 28 IS - 3 N2 - 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 =1:4 using a serum bactericidal assay with human complement (hSBA). RESULTS: Two doses of MenACWY-CRM induced hSBA titers > 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 > 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. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/19209097/Immunogenicity_and_immune_memory_of_a_nonadjuvanted_quadrivalent_meningococcal_glycoconjugate_vaccine_in_infants_ L2 - https://doi.org/10.1097/INF.0b013e31818e037d DB - PRIME DP - Unbound Medicine ER -