Rennels M B, Losonsky G A, Young A E, Shindledecker C L, Kapikian A Z, Levine M M
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Am J Dis Child. 1990 May;144(5):601-4. doi: 10.1001/archpedi.1990.02150290095037.
A double-blind, placebo-controlled trial of oral rhesus rotavirus vaccine at a dose of 10(4) plaque-forming units was performed in 114 young infants in Maryland. Significantly more vaccinees than controls had fever and vomiting during the week after vaccination, but these reactions were mild. Of the vaccinees, 83% had a fourfold or greater rise in neutralizing antibody to rhesus rotavirus vaccine and 69% shed vaccine virus. Seventeen percent of the vaccinees and 24% of controls had rotavirus-positive diarrhea during the 2 years of surveillance. Vaccine efficacy was therefore 29% (95% confidence limits, -31% to +66%). Stools from 12 of 13 episodes containing sufficient antigen to type were serotype 1. We conclude that rhesus rotavirus vaccine was infective, immunogenic, and probably acceptably attenuated but that this serotype 3 vaccine provided little heterotypic protection during serotype 1 outbreaks in the community.
在马里兰州，对114名幼儿进行了一项双盲、安慰剂对照试验，口服剂量为10⁴蚀斑形成单位的恒河猴轮状病毒疫苗。接种疫苗后的一周内，出现发热和呕吐的疫苗接种者显著多于对照组，但这些反应较为轻微。在疫苗接种者中，83%对恒河猴轮状病毒疫苗的中和抗体有四倍或更高的增长，69%排出了疫苗病毒。在两年的监测期内，17%的疫苗接种者和24%的对照组出现了轮状病毒阳性腹泻。因此，疫苗效力为29%（95%置信区间，-31%至+66%）。13次发作中有12次的粪便含有足够用于分型的抗原，均为1型血清型。我们得出结论，恒河猴轮状病毒疫苗具有感染性、免疫原性，并且可能减毒程度可接受，但这种3型疫苗在社区1型血清型爆发期间几乎没有提供异型保护。
