Pondo Tracy, Rose Charles E, Martin Stacey W, Keitel Wendy A, Keyserling Harry L, Babcock Janiine, Parker Scott, Jacobson Robert M, Poland Gregory A, McNeil Michael M
Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Vaccine. 2014 Jun 12;32(28):3548-54. doi: 10.1016/j.vaccine.2014.04.025. Epub 2014 Apr 24.
Anthrax vaccine adsorbed (AVA) administered intramuscularly (IM) results in fewer adverse events (AEs) than subcutaneous (SQ) administration. Women experience more AEs than men. Antibody response, female hormones, race, and body mass index (BMI) may contribute to increased frequency of reported injection site AEs.
We analyzed data from the CDC AVA human clinical trial. This double blind, randomized, placebo controlled trial enrolled 1563 participants and followed them through 8 injections (AVA or placebo) over a period of 42 months. For the trial's vaccinated cohort (n=1267), we used multivariable logistic regression to model the effects of study group (SQ or IM), sex, race, study site, BMI, age, and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade. Also, in a women-only subset (n=227), we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs.
Participants who received SQ injections had significantly higher proportions of itching, redness, swelling, tenderness and warmth compared to the IM study group after adjusting for other risk factors. The proportions of redness, swelling, tenderness and warmth were all significantly lower in blacks vs. non-black participants. We found arm motion limitation, itching, pain, swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations. In the SQ study group, redness and swelling were more common for obese participants compared to participants who were not overweight. Females had significantly higher proportions of all AEs compared to males. Menstrual phase was not associated with any AEs.
Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by sex and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants.
肌肉注射吸附炭疽疫苗（AVA）导致的不良事件（AE）比皮下注射少。女性经历的不良事件比男性多。抗体反应、女性激素、种族和体重指数（BMI）可能导致报告的注射部位不良事件频率增加。
我们分析了美国疾病控制与预防中心AVA人体临床试验的数据。这项双盲、随机、安慰剂对照试验招募了1563名参与者，并在42个月的时间里对他们进行了8次注射（AVA或安慰剂）。对于试验中的接种疫苗队列（n = 1267），我们使用多变量逻辑回归来模拟研究组（皮下或肌肉注射）、性别、种族、研究地点、BMI、年龄和接种疫苗后血清抗保护性抗原（PA）IgG对任何严重程度等级不良事件发生的影响。此外，在仅女性亚组（n = 227）中，我们评估了接种疫苗前血清孕酮水平和月经周期对不良事件的影响。
在调整其他风险因素后，与肌肉注射研究组相比，接受皮下注射的参与者出现瘙痒、发红、肿胀、压痛和发热的比例显著更高。黑人参与者出现发红、肿胀、压痛和发热的比例均显著低于非黑人参与者。我们发现，抗PA IgG浓度最高的参与者更有可能出现手臂活动受限、瘙痒、疼痛、肿胀和压痛。在皮下注射研究组中，肥胖参与者出现发红和肿胀的情况比非超重参与者更常见。女性出现所有不良事件的比例均显著高于男性。月经周期与任何不良事件均无关联。
女性和非黑人参与者出现与AVA相关不良事件的比例更高，且抗PA IgG浓度更高。对其他疫苗的抗体反应也可能因性别和种族而异。进一步的研究可能有助于更好地理解女性和非黑人参与者中不良事件比例较高的原因。
