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曾有人提议或正在发展几种疫苗,以预防人类轮状病毒性腹泻,但仅RIT株在儿童中达到了试验领域的阶段。RIT4237株来源于牛,生长至高滴度并能在细胞基质中繁殖以产生人体疫苗。在成人和儿童的初步试验表明,疫苗能刺激同种抗体反应而无任何副作用,本文对年龄6～12个月的331例婴儿,接受口服两剂RIT4237活减毒疫苗或安慰剂,间隔1月。进行随机双盲对照试验以观察疫苗的效率。结果:在9月～11月非轮状病毒流行期口服疫苗,研究组在接种完成之后收集血清标本之前,仅3例发生了轮状病毒腹泻。其余328例婴儿,168例接受疫苗,160例接受安慰剂。婴儿对疫苗耐受良好,在接种后初10日内未见发生腹泻。5%的婴儿在接种当日及次日有烦燥不安,但疫苗组与安慰剂组无差别,许多婴儿接种时有轻度鼻炎,随访期两组鼻涕均增多,两组均有少数中耳炎病例。接种后69例发生了急性腹泻或其它急性胃肠道疾病。45例需要治疗,39例(56.5%)大便中培养出轮状病毒,其中31例发生临床显著的腹泻,占需治疗者
Several vaccines have been proposed or are being developed to prevent human rotavirus diarrhea, but only RIT strains have reached the test field in children. The RIT4237 strain is derived from cattle, grows to high titers and can multiply in the cell matrix to produce human vaccines. Preliminary trials in adults and children showed that the vaccine stimulated alloantibody responses without any side effects. In this study, 331 infants aged 6 to 12 months received either two doses of the live attenuated RIT 4237 live attenuated vaccine or placebo at intervals of January . A randomized double-blind controlled trial was conducted to observe the efficiency of the vaccine. RESULTS: Before oral administration of the vaccine during non-rotavirus seasons from September to November, rotavirus diarrhea occurred in only 3 patients before the study group collected serum samples after vaccination was completed. The remaining 328 infants, 168 received the vaccine and 160 received placebo. The baby was well tolerated of the vaccine and no diarrhea occurred within the first 10 days after vaccination. Five percent of infants were annoyed on the day of vaccination and the next day, but there was no difference between the vaccine group and the placebo group. Many infants had mild rhinitis at vaccination. Both groups had increased nasal discharge during follow-up, with a small number of otitis media cases in both groups. 69 cases of acute diarrhea or other acute gastrointestinal disease occurred after inoculation. Of the 45 patients requiring treatment, 39 (56.5%) developed rotavirus stools, 31 of whom developed clinically significant diarrhea, accounting for the need for treatment