%0 Journal Article %1 wong_immunogenicity_2009 %A Wong, Sharon H %A Lennon, Diana R %A Jackson, Catherine M %A Stewart, Joanna M %A Reid, Stewart %A Ypma, Ellen %A O'Hallahan, Jane M %A Oster, Philipp %A Mulholland, Kim %A Martin, Diana R %D 2009 %J The Pediatric Infectious Disease Journal %K imported %N 5 %P 385--390 %R 10.1097/INF.0b013e318195205e %T Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine %U http://www.ncbi.nlm.nih.gov/pubmed/19384263 %V 28 %X BACKGROUND: An outer membrane vesicle meningococcal vaccine (MeNZB), was developed for the New Zealand epidemic strain of Neisseria meningitidis B:4:P1.7-2,4. METHODS: A phase II, randomized, observer blind, controlled study evaluating the safety, reactogenicity, and immunogenicity of MeNZB administered with routine New Zealand immunizations at 6 weeks, 3 months, and 5 months of age (n = 375). Group 1 (n = 250) received 25 mug MeNZB and routine immunizations with a fourth MeNZB dose given at 10 months (n = 51). Group 2 (n = 125) received routine immunizations only. Sero-response was a \textgreater or =4-fold rise in vaccine strain serum bactericidal antibody titer compared with baseline or a titer of at least 1:8 for baselines \textless1:4. Reactogenicity was monitored for 7 days after vaccination. RESULTS: Sero-response in Group 1 was achieved in 53\% (95\% Confidence interval CI: 46-59, n = 239) and 69\% (95\% CI: 54-80, n = 45) with geometric mean antibody titers of 9 (95\% CI: 7-10) and 22 (95\% CI: 12-39) after the third and fourth doses, respectively. No negative interference by MeNZB on routine immunizations was detected. There were no serious adverse events judged to be vaccine related. CONCLUSIONS: In this group of New Zealand infants, 4 MeNZB doses were required to demonstrate titers comparable with those achieved after 3 doses in older children. MeNZB was safe when used concomitantly with routine New Zealand immunizations to 5 months of age.

@article{wong_immunogenicity_2009, abstract = {{BACKGROUND:} An outer membrane vesicle meningococcal vaccine {(MeNZB),} was developed for the New Zealand epidemic strain of Neisseria meningitidis {B:4:P1.7-2,4.} {METHODS:} A phase {II,} randomized, observer blind, controlled study evaluating the safety, reactogenicity, and immunogenicity of {MeNZB} administered with routine New Zealand immunizations at 6 weeks, 3 months, and 5 months of age (n = 375). Group 1 (n = 250) received 25 mug {MeNZB} and routine immunizations with a fourth {MeNZB} dose given at 10 months (n = 51). Group 2 (n = 125) received routine immunizations only. Sero-response was a {\textgreater} or =4-fold rise in vaccine strain serum bactericidal antibody titer compared with baseline or a titer of at least 1:8 for baselines {\textless}1:4. Reactogenicity was monitored for 7 days after vaccination. {RESULTS:} Sero-response in Group 1 was achieved in 53\% (95\% Confidence interval {[CI]:} 46-59, n = 239) and 69\% (95\% {CI:} 54-80, n = 45) with geometric mean antibody titers of 9 (95\% {CI:} 7-10) and 22 (95\% {CI:} 12-39) after the third and fourth doses, respectively. No negative interference by {MeNZB} on routine immunizations was detected. There were no serious adverse events judged to be vaccine related. {CONCLUSIONS:} In this group of New Zealand infants, 4 {MeNZB} doses were required to demonstrate titers comparable with those achieved after 3 doses in older children. {MeNZB} was safe when used concomitantly with routine New Zealand immunizations to 5 months of age.}, added-at = {2011-03-11T10:05:34.000+0100}, author = {Wong, Sharon H and Lennon, Diana R and Jackson, Catherine M and Stewart, Joanna M and Reid, Stewart and Ypma, Ellen and {O'Hallahan}, Jane M and Oster, Philipp and Mulholland, Kim and Martin, Diana R}, biburl = {https://www.bibsonomy.org/bibtex/253f1031f667a5788d3b8e0ed68ac86d8/jelias}, doi = {10.1097/INF.0b013e318195205e}, interhash = {7fe7ac09dc68e290c61aaa5c2974125f}, intrahash = {53f1031f667a5788d3b8e0ed68ac86d8}, issn = {0891-3668}, journal = {The Pediatric Infectious Disease Journal}, keywords = {imported}, month = may, note = {{PMID:} 19384263}, number = 5, pages = {385--390}, timestamp = {2011-03-11T10:05:52.000+0100}, title = {Immunogenicity and tolerability in infants of a New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine}, url = {http://www.ncbi.nlm.nih.gov/pubmed/19384263}, volume = 28, year = 2009 }