Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Vaccine. 2012 Aug 31;30(40):5875-9. doi: 10.1016/j.vaccine.2012.06.076. Epub 2012 Jul 17.
After the Department of Defense implemented a mandatory anthrax vaccination program in 1998 concerns were raised about potential long-term safety effects of the current anthrax vaccine. The CDC multicenter, randomized, double-blind, placebo-controlled Anthrax Vaccine Adsorbed (AVA) Human Clinical Trial to evaluate route change and dose reduction collected data on participants' quality of life. Our objective is to assess the association between receipt of AVA and changes in health-related quality of life, as measured by the SF-36 health survey (Medical Outcomes Trust, Boston, MA), over 42 months after vaccination.
1562 trial participants completed SF-36v2 health surveys at 0, 12, 18, 30 and 42 months. Physical and mental summary scores were obtained from the survey results. We used Generalized Estimating Equations (GEE) analyses to assess the association between physical and mental score difference from baseline and seven study groups receiving either AVA at each dose, saline placebo at each dose, or a reduced AVA schedule substituting saline placebo for some doses.
Overall, mean physical and mental scores tended to decrease after baseline. However, we found no evidence that the score difference from baseline changed significantly differently between the seven study groups.
These results do not favor an association between receipt of AVA and an altered health-related quality of life over a 42-month period.
1998 年，美国国防部实施了强制性炭疽疫苗接种计划，此后人们对当前炭疽疫苗的潜在长期安全性影响表示担忧。疾病预防控制中心（CDC）开展了一项多中心、随机、双盲、安慰剂对照的炭疽疫苗吸附剂（AVA）人体临床试验，以评估接种途径的改变和剂量的减少，该试验收集了参与者生活质量的数据。我们的目的是评估在接种后 42 个月内，接受 AVA 与健康相关生活质量变化之间的关联，该变化通过 SF-36 健康调查（医学成果信托基金会，波士顿，MA）进行测量。
1562 名试验参与者在 0、12、18、30 和 42 个月时完成了 SF-36v2 健康调查。从调查结果中获得了身体和精神综合评分。我们使用广义估计方程（GEE）分析来评估从基线到七个研究组的物理和心理评分差异之间的关联，这些研究组分别接受了每种剂量的 AVA、每种剂量的生理盐水安慰剂或替代了某些剂量的生理盐水安慰剂的减少剂量的 AVA 方案。
总体而言，身体和精神评分的平均值在基线后趋于下降。然而，我们没有发现证据表明七个研究组之间的基线评分差异有显著不同的变化趋势。
这些结果不支持在 42 个月期间接受 AVA 与改变健康相关生活质量之间存在关联。
