Novartis Menveo® vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial

* First Phase III, head-to-head data show Menveo may offer greater protection for adolescents compared to Menactra*

* Novartis expects Menveo to be first quadrivalent meningococcal vaccine to protect from early infancy through adulthood

* More than 8 million infants and adolescents in the US and a significant number of children and travellers globally could benefit from Menveo[1]

New Phase III data for Menveo® (MenACWY-CRM) show that the vaccine produced a greater immune response against meningococcal serogroups A, C, W-135 and Y in adolescents 11-18 years of age compared to Menactra®. Infection with any of these four vaccine-preventable serogroups can lead to bacterial meningitis, an infection of the membrane around the brain and spinal cord, or sepsis, a serious infection of the blood stream.
Results of this first head-to-head trial of Menveo compared to Menactra, show that adolescents who were immunized with Menveo generated higher levels of antibodies against all four serogroups[2].
Notably for serogroup Y, among adolescents with low levels of immunity at the time of vaccination, 81% of subjects receiving Menveo generated a protective immune response vs. 54% with Menactra[2], as measured by the hSBA assay. Serogroup Y causes approximately 39% of meningococcal disease cases in the US[3].
“To protect children against all major serogroups of meningococcal disease, we need vaccines that provide broad coverage and that can be used in all at-risk age groups,” said Keith S. Reisinger, MD, MPH, Medical Director, Primary Physicians Research, Inc. Pittsburgh, PA. “These data are encouraging because they show that Menveo may provide greater protection for the more than 8 million infants and adolescents in the US against these four vaccine-preventable serogroups than the currently available vaccine.”
Menveo is an investigational quadrivalent meningococcal conjugate vaccine in Phase III clinical development by Novartis Vaccines. The data were presented at a late-breaker platform session on May 5 during the 2008 Pediatric Academic Societies (PAS) Annual Meeting in Honolulu, Hawaii.
Meningococcal disease, a leading cause of bacterial meningitis, is a rare but contagious and potentially life-threatening infection. Infants and adolescents have the highest rates of disease[4a], which can be fatal. Each year approximately 1,400 to 2,800 cases of disease occur in the US[4b], and about 10-14 percent of patients die[4c]. The currently available vaccines are not licensed for use in infants, in whom the highest rates of meningococcal disease are observed. Phase II data published in the January 9, 2008, issue of the Journal of the American Medical Association demonstrated Menveo to be the first meningococcal vaccine to produce a strong immune response in infants[5].
The US Centers for Disease Control and Prevention (CDC) recommends routine immunization with a quadrivalent meningococcal conjugate vaccine for all adolescents 11-18 years of age, college freshmen living in dormitories and people in other high risk groups who are two to ten or 19 to 55 years of age[6,7].
“The patient need for vaccines for meningococcal disease remains substantial. We appear to be quickly realizing our goal of providing broad coverage against all serogroups of meningococcal disease across all age groups,” said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics. “Given the broad range of age groups this vaccine is expected to protect, Menveo could truly fulfill an unmet need in the meningitis vaccine market.”
Study details[2]
This Phase III trial involved more than 2,100 11-18 year olds who received a single vaccination with either Menveo or Menactra. One month after vaccination, geometric mean titers (a measure of immune response) for Menveo vs. Menactra were: serogroup A, 29 vs. 18; serogroup C, 59 vs. 47; serogroup W-135, 87 vs. 44; and serogroup Y, 51 vs. 18. Additionally, the percentage of participants who achieved a protective immune response, determined by a human serum bactericidal antibody titer (hSBA) - 1:8, with Menveo vs. Menactra was: serogroup A, 75% vs. 67%; serogroup C, 84% vs. 84%; serogroup W-135, 96% vs 88%; and serogroup Y, 88% vs. 69%. Similar results were seen in the large subset of sero-negative participants, who are the participants without any natural immunity to the bacteria before vaccination. The hSBA assay measures the body’s protective immune response to the meningococcus based on the ability of antibodies to kill the bacteria.