Oster Philipp, Lennon Diana, O'Hallahan Jane, Mulholland Kim, Reid Stewart, Martin Diana
Chiron Vaccines, Siena, Italy.
Vaccine. 2005 Mar 18;23(17-18):2191-6. doi: 10.1016/j.vaccine.2005.01.063.
Clinical studies have been conducted in New Zealand evaluating the safety and immunogenicity of an outer membrane vesicle (OMV) vaccine, MeNZB, developed to control epidemic disease caused by group B meningococci, subtype P1.7b,4. MeNZB, administered in a three-dose regimen, was well tolerated and induced a seroresponse, defined as a four-fold rise (> or =titre 8) in serum bactericidal antibodies against the vaccine strain 4-6 weeks after the third vaccination, in 96% (95% confidence interval (CI): 79-100%) of adults, 76% (95% CI: 72-80%) of children, 75% (95% CI: 69-80%) of toddlers and 74% (95% CI: 67-80%) of infants receiving MeNZB. In conclusion, these findings suggest that MeNZB is safe and is likely to confer protection against systemic group B meningococcal disease caused by the epidemic strain.
在新西兰开展了临床研究,评估一种外膜囊泡(OMV)疫苗MeNZB的安全性和免疫原性。该疫苗是为控制由B群脑膜炎奈瑟菌P1.7b,4亚型引起的流行病而研发的。以三剂方案接种的MeNZB耐受性良好,并能诱导血清反应,即第三次接种后4至6周,针对疫苗菌株的血清杀菌抗体出现四倍增长(滴度≥8)。在接种MeNZB的成年人中,96%(95%置信区间(CI):79 - 100%)出现血清反应;儿童中为76%(95% CI:72 - 80%);幼儿中为75%(95% CI:69 - 80%);婴儿中为74%(95% CI:67 - 80%)。总之,这些研究结果表明MeNZB是安全的,并且可能对由流行菌株引起的全身性B群脑膜炎球菌病提供保护。