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DGDispatch
Quadrivalent Meningococcal Conjugate Vaccine Has Staying Power: Presented at ESPID
By Neil Osterweil
GRAZ, Austria -- May 15, 2008 -- A novel quadrivalent meningococcal conjugate vaccine is both well tolerated and immunogenic in all paediatric age groups, investigators reported here at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID).
Data from phase 2 and 3 studies suggest that the vaccine, evokes good immunogenic responses when given to infants, toddlers, school children, and adolescents, according to Steven Black, MD, Professor of Paediatrics and Infectious Diseases, Cincinnati Children's Hospital Medical Center in Cincinnati, Ohio, and colleague Peter M. Dull, MD, Head, Development of Meningococcal Conjugate Vaccines, Novartis Vaccines and Diagnostics, Emeryville, California.
The quadrivalent vaccine consists of polysaccharides of Neisseria meningitidis serogroups A, C, W-135, and Y conjugated to diphtheria toxoid cross-reactive material (MenACWY-CRM).
The authors analysed data on tolerability and immunogenicity of the vaccine in 5 separate clinical trials conducted in Canada, the United Kingdom, and the United States and involving a total of 4,364 children aged 2 months to 18 years.
Children received the vaccine as 2 doses (at 6 and 12 months), as 3 doses (at 2, 3, and 4 months or at 2, 4, and 6 months), or as a single dose at 12 months of age.
Immunogenicity was evaluated by serum bactericidal assay using an exogenous human complement source (hSBA) measured, in most cases, 1 month after vaccination.
The researchers determined the vaccine's safety and tolerability using reactions during the 7 days after the vaccination -- solicited from patients' parents -- as well as all adverse events for 1-month postvaccination, all serious and medically significant adverse events, and any adverse event leading to withdrawal from the study.
Results show that the vaccine was immunogenic against all serogroups when it was administered in a 2- or 3-dose schedule, and was also immunogenic when administered as a single dose at 12 months of age.
In the subgroup of patients aged 2 to 10 years, the vaccine produced a higher proportion of hSBA titres 1:4 or greater than did the comparator quadrivalent meningococcal polysaccharide vaccine MPSV4 (already on the market).
Among adolescents, MenACWY-CRM produced a superior response against 3 of the 4 serotypes, except C, compared with the quadrivalent conjugate vaccine MCV4. A superior response also was determined at the 95% confidence interval lower limit of MenACWY-CRM versus MCV4 >0%.
The MenACWY-CRM vaccine, which is in ongoing phase 3 trials, can be given to patients who have already received meningococcal C conjugate vaccine, the authors stated.
Funding for this study was provided by Novartis Vaccines and Diagnostics.
[Presentation title: MenACWY-CRM, a Novel Quadrivalent Meningococcal Vaccine, Is Well Tolerated and Immunogenic in Infancy Through to Adolescence. Abstract 595]
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