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首页> 外文期刊>Infection and immunity >Enteric Immunization with Live Adenovirus Type 21 Vaccine I. Tests for Safety, Infectivity, Immunogenicity, and Potency in Volunteers
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Enteric Immunization with Live Adenovirus Type 21 Vaccine I. Tests for Safety, Infectivity, Immunogenicity, and Potency in Volunteers

机译：用21型腺病毒活疫苗进行肠内免疫I.志愿者的安全性，传染性，免疫原性和效力测试

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Studies were undertaken in volunteers to determine whether living adenovirus type 21 (ADV-21) vaccine could be safely administered orally to susceptible young adults. In the first study, ten volunteers were fed 106.4 tissue culture infectious dose50 (TCID50) of ADV-21 vaccine virus, and five received placebo tablets. Nine of ten infected volunteers shed ADV-21 in stools (mean duration, 10.1 days; range, 4 to 17 days). No pharyngeal excretion of ADV-21 was observed in any of these volunteers. Each of the nine developed type-specific neutralizing (N) antibodies to ADV-21. No evidence for person-to-person transmission of vaccine was observed. In a second study, volunteers were immunized with ADV-21 vaccines containing 106.8, 104.6, and 102.4 TCID50. ADV-21 N antibody responses were detected in nine of eleven who received the highest dose, six of twelve who received the middle dose, and two of twelve who were fed the lowest dose. None of twelve susceptible volunteers receiving the placebo capsule developed ADV-21 N antibodies postimmunization. This study established that the human infectious dose50 for these lots of ADV-21 vaccine was approximately 104.6 TCID50 and that the dose response to ADV-21 vaccine was lower than those previously reported for live ADV-4 and ADV-7 enteric vaccines.
机译：在志愿者中进行了研究，以确定是否可以对易感染的年轻人安全地口服21型腺病毒（ADV-21）活疫苗。在第一项研究中，向十名志愿者喂食10 6.4 组织培养感染剂量 50 （TCID 50 ）ADV-21疫苗病毒，五名接受安慰剂片。 10名受感染的志愿者中有9名在粪便中脱落了ADV-21（平均持续时间10.1天;范围4至17天）。这些志愿者中均未观察到ADV-21的咽部排泄。九种开发的针对ADV-21的类型特异性中和（N）抗体中的每一种。没有观察到人对人传播疫苗的证据。在第二项研究中，志愿者接受了含有10 6.8 ，10 4.6 和10 2.4 TCID 50 < / sub>。在接受最高剂量的11人中，有9人检测到ADV-21 N抗体反应，接受中等剂量的12人中有6人，接受最低剂量的12人中有2人检测到。接受安慰剂胶囊的十二名易感志愿者中没有一个在免疫后产生ADV-21 N抗体。这项研究确定，这些批次的ADV-21疫苗的人感染剂量 50 约为10 4.6 TCID 50 ，并且对ADV-21疫苗的活性低于先前报道的ADV-4和ADV-7肠溶性活疫苗。

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