White W G, Barnes G M, Barker E, Gall D, Knight P, Griffith A H, Morris-Owen R M, Smith J W
J Hyg (Lond). 1973 Jun;71(2):283-97. doi: 10.1017/s0022172400022750.
In a factory population the occurrence of reactions to tetanus toxoid was recorded after 6740 injections. The incidence of general reactions was 0.3% and of local reactions 2.6%. The local reaction rate to the first injection of the basic immunization course was 0.9%, to the second injection 2.7%, and to the third injection 7.4%. To booster injections the rate was 1.6%. The local reaction rate was appreciably higher in women than in men - 14.4% and 5.7% respectively in the case of the third injection - and the incidence among women increased with age.Tetanus vaccine containing 10 Lf of toxoid caused fewer reactions than one containing 20 Lf, but a reduction in the content of aluminium adjuvant did not affect the reaction rate.Almost all reactors were found to have a satisfactory serum antitoxin concentration at the time of the reaction or developed a satisfactory immunity within 1-6 months.Skin tests were made in 32 hypersensitive patients. Neither the diluent, thiomersal preservative, nor the culture medium appeared to be responsible for hypersensitivity. The degree of hypersensitivity elicited by a special highly purified toxoid was only very slightly less than that elicited by the commercially pure toxoid. It is suggested that reactions are largely due to the toxoid antigen itself rather than to impurities or other components of the vaccine.
在一个工厂人群中，记录了6740次破伤风类毒素注射后的反应发生情况。全身反应发生率为0.3%，局部反应发生率为2.6%。基础免疫程序首次注射的局部反应率为0.9%，第二次注射为2.7%，第三次注射为7.4%。加强注射的反应率为1.6%。女性的局部反应率明显高于男性——第三次注射时分别为14.4%和5.7%——且女性中的发生率随年龄增长而增加。含10Lf类毒素的破伤风疫苗引起的反应比含20Lf的少，但铝佐剂含量的降低并未影响反应率。几乎所有有反应者在反应时血清抗毒素浓度都令人满意，或在1至6个月内产生了令人满意的免疫力。对32名过敏患者进行了皮肤试验。稀释剂、硫柳汞防腐剂和培养基似乎都不是过敏的原因。一种特殊的高度纯化类毒素引发的过敏程度仅比市售纯类毒素引发的略低。提示反应很大程度上是由于类毒素抗原本身，而非疫苗的杂质或其他成分。
