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Pivotal study confirms potential of Novartis candidate vaccine Bexsero to help protect infants against meningococcal serogroup B disease
10-02-2012: The Journal of the American Medical Association (JAMA) published a study that shows Bexsero induced a robust immune response against meningococcal B disease in the vast majority of infants vaccinated. These results also show that Bexsero can fit into various vaccination schedules in the first year of life when the likelihood of contracting this often-deadly disease is greatest. The study also demonstrated that Bexsero has an acceptable tolerability profile. These data were first presented in 2011 at the 29th Annual Meeting of the European Society of Paediatric Infectious Diseases (ESPID).
"The publication of these results in JAMA add to the growing body of evidence supporting Bexsero's potential to help protect all age groups, from infants to adults, against this devastating disease." said Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. "Bexsero holds great promise in providing a solution to a major public health concern - the lack of a routine vaccine providing broad protection against MenB,"
"The development of a broadly protective vaccine against MenB disease has been a formidable challenge and, if successful, would represent an enormous step forward in the prevention of childhood meningitis," said Dr Matthew Snape, Consultant in Vaccinology and General Paediatrics, University of Oxford, UK. "This study provides important data on how well infants' immune systems respond to this new MenB vaccine when given in a variety of schedules. This information is vital when considering how the vaccine could be incorporated into different immunization regimens around the world."
This pivotal Phase IIb open-label immunogenicity study randomized 1,885 infants to receive Bexsero at 2, 4, 6 months together with routine infant vaccines; at 2, 4, 6 months with routine vaccines given separately at 3, 5, 7 months; or at 2, 3, 4 months together with routine infant vaccines. A control group received the routine vaccines only at 2, 3, 4 months. The routine vaccines used were 7-valent pneumococcal glycoconjugate vaccine and a combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and Haemophilus influenzae type b vaccine.
Immune response was measured using the human serum bactericidal antibody (hSBA) assay with a titer >= 1:5, which is the accepted level that correlates with protection. The study met all of its primary endpoints, and showed that the majority of infants vaccinated with Bexsero, at either dosing schedule with or without routine vaccines, achieved hSBA >= 1:5 against all vaccine antigens in tested MenB strains (H44/76, 5/99, NZ98/254). More than 99% of participants receiving Bexsero at 2, 4, 6 months (with or without routine vaccines) or at 2, 3 and 4 months (with routine vaccines) developed hSBA titers >= 1:5 against the reference strains 44/76 and 5/99. For NZ98/254 the >= 1:5 result was reached or exceeded in 79% (2, 4, 6 months with routine vaccines), 87% (2, 4, 6 months without routine vaccines) and 81% (2, 3, 4 months with routine vaccines) of patients on the corresponding schedules.
The immune response to routine vaccine antigens when co-administered with Bexsero was similar to that in the control group, except for slightly lower immune responses to pneumococcal serotype 6B and pertactin, comparable with other licensed vaccines.
The data also showed that Bexsero, when administered alone, had a reactogenicity profile that was comparable to those of the routine vaccines. Fever, which is a common event following routine childhood immunizations, was observed more frequently in infants who received Bexsero together with routine infant vaccines compared to infants receiving routine vaccines alone. Fever was generally mild-to-moderate and of short duration, with more than 95% of cases resolving within 24-48 hours.
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