BACKGROUND: New Zealand has experienced an epidemic of Neisseria meningitidis dominated by strain B:4:P1.7b,4 since 1991. Children younger than 5 years are at highest risk. Previous serogroup B outer membrane vesicle (OMV) strain specific vaccines have shown variable efficacy in this age group. OBJECTIVE: To evaluate the immunogenicity, reactogenicity and safety in 16-24-month-old children of an OMV vaccine developed against the New Zealand epidemic strain. METHODS: Children (332) aged 16-24 months were randomized to receive the New Zealand candidate vaccine made using strain NZ98/254 (B:4:P1.7b,4) or the Norwegian parent vaccine made using strain 44/76 (B:15:P1.7,16). Vaccines (25 microg/dose) were administered at 0, 6 and 12 weeks in this observer-blind trial. Immune response was measured by serum bactericidal assay and enzyme-linked immunosorbent assay. Sero-response was defined as a 4-fold or greater rise in serum bactericidal antibody titer compared with baseline, with titers <1:4 required to increase to >or=1:8 to be considered a sero-response. Local and systemic reactions were monitored for 7 days after vaccination. RESULTS: Sero-response against NZ98/254 was achieved after 3 doses in 75% (95% CI: 69-80%) receiving the New Zealand candidate vaccine by both intention to treat (ITT) and per protocol (PP) analyses. In Norwegian parent vaccinees this was seen in 3% (0-12%) (ITT) and 4% (0-13%) (PP). Vaccines were well tolerated with no vaccine-related serious adverse events. CONCLUSION: The New Zealand candidate vaccine administered to these 16-24-month-old children in 3 doses was safe and elicited a promising immune response against the candidate vaccinestrain NZ98/254 (N. meningitidis B:4:P1.7b,4) contributing to vaccine licensure for this age group.
RCT Entities:
BACKGROUND: New Zealand has experienced an epidemic of Neisseria meningitidis dominated by strain B:4:P1.7b,4 since 1991. Children younger than 5 years are at highest risk. Previous serogroup B outer membrane vesicle (OMV) strain specific vaccines have shown variable efficacy in this age group. OBJECTIVE: To evaluate the immunogenicity, reactogenicity and safety in 16-24-month-old children of an OMV vaccine developed against the New Zealand epidemic strain. METHODS:Children (332) aged 16-24 months were randomized to receive the New Zealand candidate vaccine made using strain NZ98/254 (B:4:P1.7b,4) or the Norwegian parent vaccine made using strain 44/76 (B:15:P1.7,16). Vaccines (25 microg/dose) were administered at 0, 6 and 12 weeks in this observer-blind trial. Immune response was measured by serum bactericidal assay and enzyme-linked immunosorbent assay. Sero-response was defined as a 4-fold or greater rise in serum bactericidal antibody titer compared with baseline, with titers <1:4 required to increase to >or=1:8 to be considered a sero-response. Local and systemic reactions were monitored for 7 days after vaccination. RESULTS:Sero-response against NZ98/254 was achieved after 3 doses in 75% (95% CI: 69-80%) receiving the New Zealand candidate vaccine by both intention to treat (ITT) and per protocol (PP) analyses. In Norwegian parent vaccinees this was seen in 3% (0-12%) (ITT) and 4% (0-13%) (PP). Vaccines were well tolerated with no vaccine-related serious adverse events. CONCLUSION: The New Zealand candidate vaccine administered to these 16-24-month-old children in 3 doses was safe and elicited a promising immune response against the candidate vaccine strain NZ98/254 (N. meningitidis B:4:P1.7b,4) contributing to vaccine licensure for this age group.
Authors: V Weynants; P Denoël; N Devos; D Janssens; C Feron; K Goraj; P Momin; D Monnom; C Tans; A Vandercammen; F Wauters; Jan T Poolman Journal: Infect Immun Date: 2009-03-16 Impact factor: 3.441
Authors: Vincent E Weynants; Christiane M Feron; Karine K Goraj; Martine P Bos; Philippe A Denoël; Vincent G Verlant; Jan Tommassen; Ian R A Peak; Ralph C Judd; Michael P Jennings; Jan T Poolman Journal: Infect Immun Date: 2007-07-30 Impact factor: 3.441
Authors: Johan Holst; Philipp Oster; Richard Arnold; Michael V Tatley; Lisbeth M Næss; Ingeborg S Aaberge; Yvonne Galloway; Anne McNicholas; Jane O'Hallahan; Einar Rosenqvist; Steven Black Journal: Hum Vaccin Immunother Date: 2013-03-07 Impact factor: 3.452
Authors: Asad Ali; Rabab Zehra Jafri; Nancy Messonnier; Carol Tevi-Benissan; David Durrheim; Juhani Eskola; Florence Fermon; Keith P Klugman; Mary Ramsay; Samba Sow; Shao Zhujun; Zulfiqar Bhutta; Jon Abramson Journal: Pathog Glob Health Date: 2014-01 Impact factor: 2.894