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https://hdl.handle.net/2440/70114
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Type: | Journal article |
Title: | A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers |
Author: | McVernon, J. Nolan, T. Richmond, P. Reynolds, G. Nissen, M. Lambert, S. Marshall, H. Papa, T. Rehm, C. |
Citation: | The Pediatric Infectious Disease Journal, 2012; 31(1):E15-E23 |
Publisher: | Lippincott Williams & Wilkins |
Issue Date: | 2012 |
ISSN: | 0891-3668 1532-0987 |
Statement of Responsibility: | Jodie McVernon, Terry Nolan, Peter Richmond, Graham Reynolds, Michael Nissen, Stephen B. Lambert, Helen Marshall, Thomas Papa and Christine Rehm |
Abstract: | <h4>Background</h4>Neisseria meningitidis is a leading cause of meningitis and septicemia globally. Recent shifts in serogroup dominance in some settings highlight the desirability of polysaccharide-conjugate vaccines with broader meningococcal coverage than serogroup C vaccines in widespread use.<h4>Methods</h4>We assessed the safety and immunogenicity of a single dose of meningococcal quadrivalent (A, C, W-135, Y) tetanus conjugate vaccine (TetraMen-T), administered at 1 year of age. A total of 378 children were randomized to 1 of 6 groups--5 received alternative formulations of TetraMen-T, the sixth licensed adjuvanted serogroup C conjugate vaccine (Neisvac-C). Solicited adverse event reports were collected from day 0 to 7 after vaccination and unsolicited and serious adverse event reports throughout study participation. Immunogenicity was assessed by serum bactericidal assays containing either a human (hSBA) or baby rabbit (rSBA) complement source before and 1 month after immunization.<h4>Results</h4>All vaccine formulations were safe and well tolerated. Using the various measures of immunogenicity, no consistent relationships were observed between the dose of either polysaccharide or carrier and serogroup-specific response for any one antigen. The highest-dose vaccine provided optimal coverage for all 4 serogroups, with the percentage of recipients achieving hSBA titers ≥ 8 against each as follows: A, 92%; C, 96%; W-135, 71%; Y, 82% (corresponding proportions with rSBAs titers >8 all exceeded 90%). The investigational vaccines were less immunogenic against the serogroup C capsular polysaccharide than the licensed comparator.<h4>Conclusions</h4>Studies are ongoing that will help to identify optimal scheduling of quadrivalent meningococcal conjugate vaccines, to facilitate their inclusion into national immunization programs seeking extended serogroup coverage against meningococci. |
Keywords: | vaccines meningococcal tetravalent meningococcal vaccine randomized controlled trial infant |
Rights: | © 2012 Lippincott Williams & Wilkins, Inc. |
DOI: | 10.1097/INF.0b013e31823e1e34 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/566635 http://purl.org/au-research/grants/nhmrc/1016272 |
Published version: | http://www.ncbi.nlm.nih.gov/pubmed/22094636 |
Appears in Collections: | Aurora harvest Paediatrics publications |
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