To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Investigational Meningococcal Group B Vaccine Yields Good Responses After 3 Doses: Presented at ESPID URL: http://www.pslgroup.com/dg/221602.htm Doctor's Guide May 15, 2008
By Neil Osterweil GRAZ, Austria -- May 15, 2008 -- An investigational vaccine against Neisseria meningitidis serogroup B (MenB) induced immune responses against 3 strains after the third dose, reported investigators here at the 26th Annual Meeting of the European Society of Paediatric Infectious Diseases (ESPID). Elizabeth Miller, MD, Head, Immunisation Division, Health Protection Agency, London, United Kingdom, and colleagues conducted the multicentre, randomised, phase 2 study of 150 healthy infants aged 2 months. The children were randomised to receive either the MenB vaccine -- containing recombinant surface proteins (rMenB) identified from the meningococcal genome with an outer membrane vesicle (OMV) from N. meningitidis strain NZ98/254 -- or the rMenB proteins alone (without the OMV). Patients were also randomised to receive the vaccine or proteins either according to a 2, 4, and 6 month schedule with a booster dose at 12 months or to a single injection given at the age of 12 months. The randomisation was done using a 2:2:1:1 design. After a series of 3 doses of the vaccine, antibody levels measured by serum bactericidal assay using human complement (hSBA) were 89%, 96%, and 85% against 3 reference strains of N. meningitidis. Routine vaccines given during the study included the standard paediatric immunisations. Immune response for each of the reference strains and vaccine groups was determined as the percentage of subjects with hSBA titre >1:4 and geometric mean titres. The investigators also looked at safety and tolerability of the vaccine with local and systemic reactions as solicited from patients' parents and from other unsolicited adverse events through the first week after administration, as well as serious and medically significant adverse events recorded throughout the trial. A total of 147 healthy infants completed the trial. After the second and third immunisations, responses against strains 44-76/SL and 5/99 were similar between participants who received the rMenB vaccine with or without the OMV. After the third immunisation, titres against the NZ98/254 strain in the recipients of the MenB vaccine were substantially higher compared with recipients of rMenB proteins only (85% vs 5%, respectively). The authors also found that the vaccine induced an immune response against all 3 strains that increased after the third dose. The proportion of participants with antibody titres >1:4 after the third dose were 89% for the 44-76/SL strain, 96% for the 5/99 strain, and 85% for the NZ98/254 strain. Following the 12-month booster dose, response rates were 100%, 98%, and 93%, respectively. Both local and systemic reactions were similar in frequency and intensity to routine infant immunisations with the exception of fever (axillary temperature >38 degrees Celsius), which was more common among MenB vaccine recipients than among rMenB recipients after the first injection. Meningococcal serogroup B accounts for nearly three-quarters of meningococcal disease in Europe, according to the investigators. "The prospect of 1 vaccine that protects infants worldwide against meningococcal serogroup B would be a key achievement in global disease prevention of our time," stated Ray Borrow, PhD, MRCPath, Head, Vaccine Evaluation Unit, Health Protection Agency. "Of those infected with the meningococcal B strain, there is a strong likelihood that the bacterium contains at least 1 of the antigens included in the Novartis MenB vaccine. These new findings tell us that the vaccine is likely to kill strains that contain the vaccine's antigens." The vaccine is currently in phase 3 trials. Funding for this study was provided by Novartis Vaccines. [Presentation title: Safety and Immunogenicity of Novartis Meningococcal Serogroup B Vaccine (MenB Vaccine) After Three Doses Administered in Infancy. Abstract 133] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.