[流感减毒活疫苗(Gripovax)反复专题应用后致敏性的研究[作者译]。

J Werner, E K Kuwert
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引用次数: 0

摘要

对18名既往无蛋蛋白过敏史的受试者进行了一项长期的二价流感活疫苗研究。实验条件包括九次疫苗接种计划,收集血清和鼻液。研究的参数是血清和局部抗体形成的测定以及血清和鼻液中特异性IgE抗体的证明。我们的主要兴趣是针对重复剂量的非纯化口服疫苗后的潜在致敏问题。对受试者的密切医学随访未发现特应性反应的临床体征。通常在当地接种流感活疫苗后,没有关于不良反应的投诉。试验前、试验中和试验后血清总IgE升高水平的测定;一名接种疫苗的受试者在接种前显示出高浓度,在实验期间没有显著变化。该个体最终被归类为特应性过敏症,对鸡蛋蛋白明显过敏。尽管如此,这个人耐受了九剂疫苗,没有出现副作用,也没有显示出总或特异性IgE抗体的显著增加。非特应性受试者鼻分泌物中的IgE浓度低于2U/ml,而过敏患者的IgE浓度通常较高,并且在鼻腔IgE水平大于4u /ml的情况下,可能会出现挑战过敏原的特异性反应。在我们的疫苗接种者中,鼻IgE值始终在正常范围内,没有超过2.6 U/ml,即使是特应性受试者的鼻液中也没有出现更高的水平。全身性和局部性IgE抗体的相关性显示没有病理关系;此外,在RAST中测量的针对卵清蛋白过敏原的特异性ige血清抗体未显示出与疫苗接种的任何相关性。这些数据为疫苗在人体内的反复应用提供了良好的证据。
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[Studies on sensitization after repeated topic application of live attenuated influenza vaccine (Gripovax) (author's transl)].

A long term study with bivalent live influenza vaccine was carried out in 18 subjects with no previous history of egg protein hypersensitivity. Experimental conditions included a nine-fold vaccination schedule with collection of serum and nasal fluid. The parameters studied were determination of serium and local antibody formation as well as the demonstration of specific IgE antibodies in serum and nasal fluid. Our major interest was directed towards the question of potential sensitization after repeated doses of non-purified oral vaccine. The close medical follow-up of the subjects revealed no clinical signs of atopic reaction. There were no complaints regarding adverse reactions usually following local application of live influenza vaccines. Determination of total serum IgE rederately elevated levels before, during und after the trial; one vaccinated subject showed high concentrations prior to vaccination with no significant change during the experiment. That individual was ultimately classified atopic with a pronounced hypersensitivity to egg protein. Nevertheless this person tolerated nine doses of vaccine without side reactions and showed no significant increase in total or specific IgE antibodies. Concentrations of IgE in nasal secretion of non-atopic subjects are less than 2U/ml, whereas they are frequently higher in allergic patients and in the presence of nasal IgE levels greater than 4 U/ml one would expect a specific reaction to challenge allergens. In our vaccinees nasal IgE values were consistently within normal range, at no time exceeding 2.6 U/ml, even the atopic subject did not exhibit higher levels in nasal fluid. A correlation between systemic and local IgE antibodies revealed no pathognostic relations; in addition to this, specific IgE-serum-antibodies as measured in the RAST against ovalbumin allergen did not show any correlation to vaccination. These data present good evidence for the innocuity of the vaccine with regard to its repeated application in man.

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