NONRESPONDERS TO HUMAN DIPLOID CELL RABIES VACCINE, INTRADERMAL

对人二倍体细胞狂犬病皮内疫苗无反应者

• 批准号: 3804819
• 负责人: L A SAWYER
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3804819
• 关键词: active immunization; antibody titering; antiserum; drug administration routes; drug adverse effect; drug quality /standard; epidemiology; human subject; human therapy evaluation; interview; questionnaires; rabies vaccines

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.

人二倍体细胞狂犬病疫苗获准肌肉注射 1980 年在美国上市。六年后，该疫苗获得许可用于 皮内仅用于暴露前免疫和加强剂量。全部 在获得许可之前进行的研究表明，该疫苗 非常有效，几乎每个接种疫苗的人都发生了血清转化。因为 免疫咨询委员会对疫苗的信心 狂犬病疫苗使用建议中建议的做法 仅对那些处于以下情况的人才需要进行抗体检测 持续存在感染风险，每 6 个月进行一次，并且 对于高危人群，每两年或每两年检测一次血清 给予加强剂量。疾病预防控制中心正在审查另一项研究收集的数据 发现一些人接受了暴露前方案的免疫接种 皮内途径在免疫后一年内没有效价。 我们正在与 CDC 和制造商合作分析这一发现。我们 将测试与非相关疫苗的效力 反应和对应的疫苗由相同的原料制成，但生产 为肌内途径。此外，还做了一份调查问卷 制定用于案件电话访谈。案例定义为 任何接受狂犬病暴露前免疫课程的人 完成治疗后一年内滴度<1:5的皮内途径 免疫接种。如果疫苗的效力不是我们将探讨的问题 宿主因素和皮内注射给药技术。 目前尚不清楚这些未检测到的个体是否 抗体已引发或抗体是否只是减弱；或者如果这些 个人对狂犬病疫苗没有反应。经过一个 对这些不良反应（即无反应）进行调查并做出决定 将确定是否应将血清学随访纳入其中 皮内免疫。将考虑确定是否 皮内接种应仅限于加强剂量。