NONRESPONDERS TO HUMAN DIPLOID CELL RABIES VACCINE, INTRADERMAL

年，人二倍体细胞狂犬病疫苗获得肌肉注射许可 1980年的美国。六年后，该疫苗被批准用于 皮内使用仅用于暴露前免疫和加强剂量。全 在获得许可之前进行的研究表明，疫苗是 效力很强，几乎每个人都接种了血清转换的疫苗。因为 关于对疫苗的信心，免疫咨询委员会 建议使用狂犬病疫苗的做法 抗体检测只需要对那些在 持续的感染风险，每6个月做一次，并且 对于经常有风险的人，每两年或一年检测一次血清 给出了增强剂量。美国疾病控制与预防中心审查为另一项研究收集的数据 发现有几个人接种了暴露前方案的疫苗 皮内途径在免疫后一年内没有滴度。 我们正在与疾控中心和制造商合作分析这一发现。我们 将测试与非疫苗相关的疫苗的效力 应答性疫苗和由同一批次生产的对应疫苗 用于肌肉内路径。此外，还发放了一份调查问卷 制定用于案例的电话采访。案例定义为 任何接受狂犬病暴露前免疫课程的人 效价为&lt；1：5的皮内注射途径 免疫接种。如果疫苗的效力不是我们要探讨的问题 皮内注射的宿主因素和给药技术。 目前还不清楚是否有未被检测到的个体 抗体是否被激活，或者抗体是否只是减弱了；或者如果这些 个人对狂犬病疫苗没有反应。在一次 对这些不良反应(即无反应)的调查决定 是否应该将血清学随访作为 皮内免疫。将考虑以确定是否 皮内接种应仅限于加强剂量。

Human Diploid Cell Rabies Vaccine was licensed for intramuscular use in the United States in 1980. Six years later the vaccine was licensed for intradermal use for pre-exposure immunization and booster doses only. All of the studies conducted prior to licensure indicated that the vaccine was highly potent and virtually every person vaccinated seroconverted. Because of the confidence in the vaccine, the Advisory Committee for Immunization Practices in their Recommendations for Use of Rabies Vaccine suggested that testing for antibodies was only necessary for those persons at continuous risk of infection and this was to be done every 6 months, and for persons at frequent risk sera was to be tested every two years or a booster dose given. CDC in reviewing data collected for another study found several persons immunized with the pre-exposure regimen by the intradermal route did not have a titer within one year of immunization. We are working with CDC and the manufacturer to analyze this finding. We will be testing the potency of the vaccines associated with the non- response and the counterpart vaccine made from the same bulk but produced for the intramuscular route. In addition, a questionnaire has been formulated to use in a telephone interview of cases. A case is defined as anyone receiving a rabies pre-exposure immunization course by the intradermal route whose titer is <1:5 within one year of completion of the immunization. If potency of the vaccine is not the issue we will explore host factors and technique of administration of the intradermal injection. It is not clear at this time if the individuals without detectable antibody were primed or whether the antibody had merely waned; or if these individuals failed to respond to the rabies vaccine. After an investigation into these adverse reactions (i.e. non-response) a decision will be made as to whether serological follow-up should be part of intradermal immunization.Consideration will be given to determine if intradermal inoculation should be restricted to booster doses only.