Kelly Colleen, Arnold Richard, Galloway Yvonne, O'Hallahan Jane
School of Mathematics, Statistics, and Computer Science, Victoria University, Wellington, New Zealand.
Am J Epidemiol. 2007 Oct 1;166(7):817-23. doi: 10.1093/aje/kwm147. Epub 2007 Jul 5.
The effectiveness of a new group B strain-specific meningococcal vaccine referred to as "MeNZB," developed by Chiron Vaccines (Siena, Italy) in collaboration with the Norwegian Institute of Public Health, was assessed in a prospective observational study following a nationwide vaccination program in New Zealand. The vaccination program began in July 2004, and the study uses data from January 2001 to June 2006. A generalized estimating equation model was used to estimate vaccine effectiveness that included potential confounding variables, such as disease progression over time, age, ethnicity, socioeconomic status, seasonality, and geographic region. The model provides strong statistical evidence for a vaccine effect (p < 0.0001), with estimated disease rates 3.7 times higher in the unvaccinated group than in the vaccinated group (95% confidence interval: 2.1, 6.8) and a vaccine effectiveness of 73% (95% confidence interval: 52, 85). An estimated 54 epidemic strain meningococcal cases were prevented in the 2 years since the vaccination program began (95% confidence interval assuming a fixed population size: 22, 115). In a sensitivity analysis, these estimates proved to be robust to modeling assumptions, including population estimates, estimates of the numbers vaccinated, effects of partial vaccination, and temporal autocorrelation.
由赛诺菲疫苗公司(意大利锡耶纳)与挪威公共卫生研究所合作研发的一种新型B群特异性脑膜炎球菌疫苗“MeNZB”的有效性,在新西兰全国疫苗接种计划后的一项前瞻性观察性研究中得到评估。疫苗接种计划于2004年7月开始,该研究使用了2001年1月至2006年6月的数据。采用广义估计方程模型来估计疫苗有效性,该模型纳入了潜在的混杂变量,如疾病随时间的进展、年龄、种族、社会经济地位、季节性和地理区域。该模型为疫苗效果提供了有力的统计学证据(p<0.0001),未接种疫苗组的估计疾病发病率比接种疫苗组高3.7倍(95%置信区间:2.1,6.8),疫苗有效性为73%(95%置信区间:52,85)。自疫苗接种计划开始后的两年内,估计预防了54例流行菌株脑膜炎球菌病例(假设人口规模固定的95%置信区间:22,115)。在敏感性分析中,这些估计结果被证明对建模假设具有稳健性,包括人口估计、接种人数估计、部分接种的影响以及时间自相关。