Kobayashi M, Thompson J, Tollefson S J, Reed G W, Wright P F
Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
J Infect Dis. 1994 Nov;170(5):1260-3. doi: 10.1093/infdis/170.5.1260.
A study of a tetravalent live oral rhesus rotavirus vaccine was conducted in 26 healthy infants 6-22 weeks of age to evaluate safety, viral shedding, and immunogenicity in a double-blind, placebo-controlled fashion. The tetravalent rhesus rotavirus vaccine (RRV-TV) contained equal amounts of RRV (serotype 3) and the VP7 reassortants DxRRV (serotype 1), DS1xRRV (serotype 2), and ST3xRRV (serotype 4). RRV-TV was highly infectious; 16 of 18 recipients shed virus. However, the recovered virus was almost exclusively the parent rhesus strain, RRV. Humoral immune responses were largely limited to the RRV strain. The most consistent response, seen in 14 of 18 vaccines, was an ELISA IgM response to purified RRV. Mucosal antibody responses were not seen. The limited immune response may be a function of age, presence of maternal antibody, timing of the convalescent specimens, or the polyvalent nature of the vaccine.
对26名6至22周龄的健康婴儿进行了一项四价口服恒河猴轮状病毒活疫苗研究，以双盲、安慰剂对照方式评估其安全性、病毒排泄及免疫原性。四价恒河猴轮状病毒疫苗（RRV-TV）含有等量的RRV（血清型3）以及VP7重配株DxRRV（血清型1）、DS1xRRV（血清型2）和ST3xRRV（血清型4）。RRV-TV具有高度传染性；18名接种者中有16人排出病毒。然而，回收的病毒几乎全是亲代恒河猴毒株RRV。体液免疫反应主要局限于RRV毒株。18名接种疫苗者中有14人出现的最一致反应是对纯化RRV的ELISA IgM反应。未观察到黏膜抗体反应。有限的免疫反应可能是年龄、母源抗体的存在、恢复期标本采集时间或疫苗多价性质的作用结果。
