Crick J, Brown F
Dev Biol Stand. 1978;40:179-82.
In pre-exposure immunization the protective effect of rabies vaccines can be correlated with their ability to stimulate the production of neutralizing antibodies and in post-exposure therapy also antibodies would appear to have a major role. Therefore, the potency of the vaccines may conveniently be compared by measuring their antigenicity in animals or by serum blocking tests. Nevertheless, most authorities will license, for human and veterinary use, only those vaccines which reach the required standards in the Habel or NIH tests, both of which depend upon the inoculation of more than 1 dose of vaccine followed by an intracerebral challenge. We have been involved recently in testing batches of vaccine imported into Britain for use in animals and man. Since the U.K. authorities have adopted the NIH test for this purpose we have taken the opportunity to compare some of these vaccines in the NIH test, in a modified NIH test in which the same amount of vaccine was given in a single dose, and in a test in which the production of serum neutralizing antibodies was measured. We have found that one dose of vaccine given on day 0 gave less protection and less neutralizing antibody than the same amount of vaccine given as two separate doses on day 0 and day 7. The greater effect obtained by inoculating the vaccine in two doses could thus be misleading and we suggest the adoption of a test in which a single dose is given.
在暴露前免疫中,狂犬病疫苗的保护作用与其刺激产生中和抗体的能力相关,在暴露后治疗中,抗体似乎也起主要作用。因此,通过在动物中测量疫苗的抗原性或通过血清阻断试验,可以方便地比较疫苗的效力。然而,大多数权威机构仅会批准在哈贝尔试验或国立卫生研究院试验中达到要求标准的疫苗用于人和兽医,这两种试验都需要接种超过1剂疫苗,随后进行脑内攻毒。我们最近参与了对进口到英国用于动物和人类的一批批疫苗的检测。由于英国当局为此采用了国立卫生研究院试验,我们借此机会在国立卫生研究院试验、在单剂量给予相同量疫苗的改良国立卫生研究院试验以及在测量血清中和抗体产生的试验中对其中一些疫苗进行了比较。我们发现,与在第0天和第7天分两剂给予相同量疫苗相比,在第0天给予一剂疫苗提供的保护和中和抗体更少。因此,分两剂接种疫苗所获得的更大效果可能会产生误导,我们建议采用给予单剂量的试验。