Menveo (MenACWY-CRM), a vaccine development by Novartis, may protect infants using a schedule beginning at two months of age against four of the most common causes of meningococcal disease. Menveo is the only meningococcal vaccine shown to generate protection against a broad range of serogroups in infants, potentially filling a large unmet medical need.
New data, published in the Journal of the American Medical Association, show that Menveo was well-tolerated and generated high levels of immunogenicity in infants against meningococcal serogroups A, C, W-135 and Y with a standard infant vaccination dosing schedule.
Infants have the highest rate of meningococcal disease, a potentially deadly bacterial infection. However, no currently available quadrivalent vaccine including Menomune and Menactra has demonstrated a strong and lasting immune response for this age group.
"These important data show that this new MenACWY vaccine has the potential to protect infants as part of the routine infant vaccine schedule, expanding the potential serogroup coverage of currently available vaccines," said study investigator Andrew Pollard, FRCPCH, PhD, Reader in Paediatric Infection & Immunity, University of Oxford and Honorary Consultant Pediatrician at Children's Hospital in Oxford, England.
"Infants have the highest rate of meningococcal disease, and to date no quadrivalent vaccine has been immunogenic in this high risk age group," said Steve Black, MD, Adjunct Professor of Pediatric Infectious Disease at Stanford University. "These new data are encouraging and offer promise that we will soon have a vaccine to protect all children against a broad range of serogroups that cause meningococcal disease."
These new results build on numerous other clinical trial findings, which support that Menveo generates a strong immune response across all age groups. Novartis plans regulatory submissions for Menveo in the European Union and the United States in 2008.
"Novartis is making great progress toward our goal of protecting all age groups from all causes of meningococcal disease," said Joerg Reinhardt, CEO, Novartis Vaccines and Diagnostics.
The phase II randomised, open-label trial included 421 infants from the UK and Canada and evaluated multiple schedules including two 3-dose primary schedules, at either 2, 3 and 4 months and 2, 4 and 6 months. Some participants received either an additional dose of MenACWY-CRM or a plain meningococcal polysaccharide at 12 months. One month after the last primary immunization, the percentage of participants with hSBA titers greater than or equal to 1:4 in the 2, 3, 4-month group was 93 per cent or above for all four serogroups. Immunization at 2, 4 and 6 months resulted in a similarly high percentage of participants achieving immune response for serogroups C, W-135 and Y, and 81 per cent for serogroup A. The dose at 12 months generated a strong immune response across all four serogroups, was shown to increase levels of immunity, and is likely to provide sustained protection. The hSBA titer is the human serum bactericidal antibody assay, which measures the body's protective immune response to the meningococcus.
Menveo is currently in multiple phase III clinical trials involving infants, young children, adolescents and adults. It is based on the same technical expertise Novartis used to produce Menjugate, a meningococcal serogroup C conjugate vaccine approved outside the United States since 2000 for use in individuals from two months old through adulthood.